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Keraatoconnus
Frrequen
ntly Asked
A d Questionss
and Artic
A les

Beverlly Hills, CA
310--860-19000
in
nfo@boxxerwachller.com

www
w.Kerato
oconusInnserts.coom
 
 

 
Olympic Go old Medalist, Steve Holcom
mb 
 
Steve Holcomb won Olym mpic Gold in 2
2010  Tommy P Pham 
Winter Gam mes, after undergoing C3‐R® in  Cardinals Ou utfielder 
2007 and Vissian ICL in 2008. He previo
ously   
had retiredd in 2007 due to Keratoconnus.  “It makes you feel com mfortable thatt your 
After his historic win Dr. Brian renam
med  eyes are stabilized froom Keratocon nus!” 
C3‐R® to HHolcomb C3‐R R® in his honnor.  Ho
olcomb C3‐R® ® in 2011
Holcomb C3-R®
Proprietary, Non-Invasive Crosslinking
Keratoconus is more common now than ever before. Once thought to occur in 1
in 2000 people, it is now 1 in 500 people (400% more common than in the
past). The good news is there is a way to help treat your Keratoconus and stop
it "in it's tracks" from progressing. Imagine the peace-of-mind you would
have knowing your Keratoconus is stable. How wonderful would it be to
never lose sleep over worrying about having a cornea transplant at some point
in the future!

The solution for already thousands of Keratoconus patients been a non-invasive


procedure called Holcomb C3-R® Crosslinking System.

Dr. Brian is considered the "Guru of Modern Crosslinking." People


On April 9, 2010 when Olympic Gold
regularly come from all over the United States, Canada, and other countries
Medalist Bobsledder Steve Holcomb and
because he invented the non--invasive Holcomb C3-R® Crosslinking
Dr. Brian were on Dr. Phil’s The Doctors
System in 2003 that can strengthen the weakened corneal structure in
television show, Dr. Brian announced the
keratoconus (see Presentation and Research Articles link). This unique method
name modification of “C3-R” to
works by non-invasively increasing collagen cross-linking, which are the
“Holcomb C3-R” in honor of Steve
natural "anchors" within the cornea. These anchors are responsible for
Holcomb. This marked the first time in
preventing the cornea from bulging out and becoming more steep and irregular
history that a treatment for a disease was
(which is the cause of keratoconus).
named after an Olympic athlete who
made the treatment world-famous.
The only place to have the Holcomb C3-R® Crosslinking System is at the
Boxer Wachler Vision Institute in Beverly Hills, California.

The figures above show the parallel corneal layers (white) and the collagen cross-linking (red) which are increased after
Holcomb C3-R®treatment.

In 2003, Dr. Brian invented the Holcomb C3-R® Crosslinking System- the non-invasive 30-minute, in-office procedure to
be better and safer for people than CXL which requires disruption of the epithelium. Holcomb C3-R® Crosslinking System
SAVES patients from significant pain and increased blurred vision during the first month that would otherwise occur with
removal of the epithelium. When Dr. Brian invented the "epi-on" or transepithelial crosslinking technique, he did so
because he saw the pain and problems were having from crosslinking with removal of the epithelium.

During Holcomb C3-R®, our proprietary Crosslinking Solution (containing riboflavin and other compounds) is applied to the
cornea, which is then activated by a special light.

Being invented in 2003, the Holcomb C3-R® Crosslinking System has the longest track record of all crosslinking
techniques in the United States, Canada, Latin America & South America, Asia, and Europe (with the exception of Germany).
With the Holcomb C3-R® Crosslinking System you know you are getting “the real thing” developed by modern crosslinking guru,
Dr. Brian.

Dr. Brian also developed a unique bilateral technique that allows both eyes to be treated at the same time. With the Holcomb
C3-R® Crosslinking System you won't have to come back on another day for the second eye to be stabilized (which people find to
be very inconvenient to take extra days off work or from their routine).
Removing the epithelium (as done with CXL) creates a painful recovery and
significantly increases risk of infection, corneal haze, scarring, and corneal
nerve trauma requiring 6 months to recover. The non-invasive Holcomb
C3-R® allows patients to return to their normal routine the very next day!

Our studies and studies of other eye doctors in outside countries have shown
patient results are not significantly different with crosslinking with removal of
epithelium vs. leaving epithelium undisturbed in its place. Therefore, it is not
necessary to scrape off the epithelium for crosslinking and is safer without
scraping off epithelium. Please visit www.KeratoconusInserts.com for more
information on results of Holcomb C3-R® vs epi-off (CXL) corneal crosslinking.

The risk of the Holcomb C3-R® Crosslinking System is mild irritation for a
couple of days.

The known risks of the "epi-off" (removal of epithelium) CXL crosslinking


procedure include:

1) corneal infection and ulceration


2) corneal haze
3) delayed epithelial healing
4) blurred vision
5) delay in corneal nerve regeneration
6) permanent corneal scarring
7) induced visual distortions
8) peripheral flap melting in patients who had previous LASIK

The above CXL complications have NEVER occurred with the Holcomb C3-R®Crosslinking System.

The retreatment rate is about 1% with either epi-on and epi-off techniques.

The non-surgical Holcomb C3-R® Crosslinking System is a routine part of our practice and has been so for over 8 years..

Another advantage of the Holcomb C3-R® Crosslinking System over other crosslinking methods (eg. CXL) is the Holcomb
C3-R® Crosslinking System covers the greatest corneal area for crosslinking - it covers over 150% more surface area of the
cornea compared to other techniques. This allows for a more complete area of treatment which is important since Keratoconus
extends into the periphery of the cornea. We make sure we treat the far periphery of your corneas as well as central areas with the
Holcomb C3-R® Crosslinking System.

The Holcomb C3-R® Crosslinking System can also be combined with Intacs®to flatten the Keratoconus cone even more than with
Intacs alone. We routinely perform these both procedures on the same day. In these cases, the Holcomb C3-R®Crosslinking
System can stabilize keratoconus from getting worse as well as help the Intacs® reverse part of the keratoconus steepening that
had already occurred up to the time of the treatment. The combination of same-day Intacs and the Holcomb C3-R® Crosslinking
System can give you the ideal results of improved vision AND stability.

Dr. Brian is credited as the first doctor in the world (except Germany) to use corneal crosslinking treatments for keratoconus as
well as being the first doctor in the world to combine this treatment with Intacs®. As the inventor of transepithelial Holcomb C3-
R® Crosslinking in 2003 - Dr. Brian has the longest crosslinking track record of any doctor in the United States, Canada,
Asia, Latin America & South America, and Europe (except for Germany).

Dr. Brian is considered the "Guru of Modern Crosslinking" because of his extensive experience and expertise. Would you
trust your precious eyes and the future of your vision to someone who just learned how to do the procedure?

The Holcomb C3-R® Crosslinking System is the only crosslinking procedure with an Olympic Gold Medal behind it. The United
States Olympic Committee effectively endorsed the procedure when they paid 100% of the fee for U.S. Olympic
Bobsledder Steve Holcomb to have it to save his eyesight - the procedure now bears his name in honor of what Steve
accomplished after overcoming his Keratoconus.

Finally, you can overcome your Keratoconus as well.


Right Eye Initial Eye Exam

Vision without glasses 20/40

Best Glasses Prescription gets 20/20 vision

-0.50 -0.75 x 055 (very little astigmatism) 


 

 
 
 
Note: small YELLOW cone, barely detectable

Patient was told by primary eye doctor, that possibly the keratoconus wouldn’t progress,
just wait and see.

Patient was told contacts are the first treatment choice and explained contacts could
possible stop or slow vision changes.

Patient at the advice of the primary eye doctor canceled scheduled Holcomb C3-R
Crosslinking treatment.

Original recommendation: Holcomb C3R® Crosslinking System


$3300 initial cost to preserve vision

Message should have been: Keratoconus is a progression condition. This is not a


condition to “wait and see” if it progresses. It will progress, seek Holcomb C3-R®.

Holcomb C3-R Crosslinking System is the first line defense to preserve vision.
Right Eye Exam less than 2 years later

Vision without glasses 20/150

Best glasses Prescription gets 20/25 vision

+1.25 -4.50 x 070 (significant astigmatism) 


 

 
 
 
Note: now significant RED cone and astigmatism has developed

Less than 2 years later patient returned to primary eye doctor due to significant decline
in vision, the doctor was surprised and told the patient the keratoconus had progressed.

The doctor explained he had previously learned options were contacts or transplants; he
went on to say “maybe I should look into crosslinking as option.”

The doctor apologized and told patient seek treatment ASAP.

Patient had to undergo Holcomb C3R® with INTACS and CK


$11,000 cost to improve vision & stabilize moderate Keratoconus

Take away message: Keratoconus is a progression condition. This is not a condition to


“wait and see” if it progresses. It will progress. Seek Holcomb C3-R® upon diagnosis.

Holcomb C3-R Crosslinking System is the first line defense to preserve vision. 
Keratoconus -What You Need to Know
Is there a website with more information about procedures that can help keratoconus
patients?

www.KeratoconusInserts.com

I am fine wearing my contacts right now; doesn’t that mean I don’t need to do anything?

Keratoconus is a degenerative condition that can lead to further loss of your vision and decreased
ability for good vision in glasses and/or contacts. Left untreated, keratoconus can result in the
need for you to have a cornea transplant. Even if you may not be having a problem right now, the
condition silently progresses. The longer you wait to treat keratoconus, the harder it is to treat,
and the less chance there is that you will remain comfortable in your contacts.

We like the analogy of treating the condition while it’s still a mole hill instead of waiting and
then trying to treat Mt. Everest. This is the reason at the earliest sign of keratoconus to consider
having HOLCOMB C3-R.® HOLCOMB C3-R®can “lock in” the keratoconus to prevent future
disease progression. Imagine the peace-of-mind you would have at night if you didn’t worry
about your keratoconus getting worse.

Is HOLCOMB C3-R®a surgery?

No. HOLCOMB C3-R®is a one-time non-invasive procedure/treatment, not a surgery. In 2003


Dr. Brian invented the 30 minute, non-surgical HOLCOMB C3-R®that strengthens your cornea.
HOLCOMB C3-R®addresses the underlying cause of keratoconus, weakened collagen fibers.
This treatment literally helps to strengthen those fibers by creating new crosslinks. The amazing
aspect is your recovery is just one day. The day after your procedure, you can be back to all
your normal activities.

How did Dr. Brian invent HOLCOMB C3-R®?

Many people have referred to Dr. Brian as a “genius” or the “Steve Jobs of Eye Surgery.”

Dr. Brian has a natural gift for seeing the potential in specific aspects of different surgical
techniques, then “connecting the dots” in such a way to create a “break-through” procedure that
goes on to change the lives of thousands of people.

He developed a proprietary technique for non-invasively strengthening the cornea that has given
thousands of people the peace-of-mind that their Keratoconus is not progressing and they will
likely not ever worry about a cornea transplant.

Dr. Brian authored the landmark book MODERN MANAGEMENT OF KERATOCONUS and the
forthcoming book MASTERY OF CORNEAL CROSSLINKING FOR KERATOCONUS AND
OTHER DISORDERS.
Is there a doctor close to me that preforms Holcomb C3-R®?

Because of the proprietary nature of HOLCOMB C3-R,® it is ONLY available at the Boxer
Wachler Vision Institute in Beverly Hills. Along with HOLCOMB C3-R,® Dr. Brian has used
his genius to create Intacs® for Keratoconus in 1999 and I-Brite® Eye Whitening as well as
Fortified LASIK.™ He is often referred to as the Michelangelo of eye doctors.

How did procedure ‘HOLCOMB C3-R®’ get its name?

In 2003 when Dr. Brian invented the non-invasive procedure, it was called C3-R®(representing
corneal collagen crosslinking). His patient Steve Holcomb had previously retired from bobsled
driving due to his keratoconus. Steve was treated by Dr. Brian with C3-R®and Visian ICL™ to
regain his vision and career.

At the 2010 Winter Olympics in Vancouver Steve won the Olympic Gold in 4-man bobsled,
which was the first for the United States in 62 years. Dr. Brian renamed the procedure to honor
Steve’s accomplishments as “HOLCOMB C3-R®”on Dr. Phil’s The Doctors daytime talk show.

My eye doctor told me that my RGP (hard) contact lenses hold my keratoconus back from
progressing. Is that really true?

No. This is a myth, some optometrists think that somehow a contact balancing on top of a cornea
can magically push the cornea back or stop it from bulging. To say that a contact stops
keratoconus from progressing is like saying wearing a baseball cap will prevent someone’s skull
from expanding or that a surfer pushes the wave back with the surfboard. It doesn’t happen and
that is the reason when keratoconus progresses, contacts need to be updated. The only proven
way to stop keratoconus in its tracks from progressing is with HOLCOMB C3-R.®

Is Intacs® a vision correction procedure? What is the success rate?

Intacs® are plastic rings placed under the surface of the cornea to alter its shape. Intacs® help to
reshape the steep cone. You typically won’t feel them in the same way you don’t feel a dental
filling for a cavity. Although some patients may experience some improvement in their
uncorrected (natural) visual acuity, the main purpose of the Intacs® procedure is to help flatten
the area of the cornea that is irregularly steepened and improve “best corrected” vision with
glasses or contact lenses.

Every patient is different; some patients are highly progressed and cannot wear contacts or
glasses comfortably; their goal would be to be able to wear contact lenses and/or glasses
successfully. Other patients may be newly diagnosed and wearing soft contact lenses; their goal
would be to flatten the cornea (with Intacs®) and stop the progression of keratoconus (with
HOLCOMB C3-R®) helping to remain comfortable in soft lenses and have a better quality of
vision in soft contacts or glasses.

If you don’t live locally, Dr. Brian can perform a complimentary record review for preliminary
determination of being a candidate for Intacs.®
Which is done first, Intacs® or HOLCOMB C3-R®? Can I do them both at the same time?

We routinely perform both on the same day. Dr. Brian invented that technique too. First we place
the Intacs® and then we perform the HOLCOMB C3-R.® We found that doing both procedures
on the same day can provide additional lines of improvement on the reading chart and increased
flattening of the cornea versus performing these procedures on different days. Maximum results
are obtained when doing Intacs® and HOLCOMB C3-R®on the same day, in that order.
When both procedures are performed on the same day, the Intacs® are implanted and then the
HOLCOMB C3-R®treatment is done. It takes about 50 minutes to do both procedures on one
eye, and only slightly longer if we do both eyes on the same day. You will be in our office for
approximately 3-4 hours on the day of the treatments between check in and check out.

Is there anyone near me that performs Intacs®?

Dr. Brian is regarded as the inventor of these procedures and has likely performed more of them
than any other eye surgeon in the world (he has performed thousands upon thousands of them).
Dr. Brian has been performing Intacs® since 1999 and HOLCOMB C3R® since 2003.

At the end of July, 2004 the FDA officially recognized Intacs® as a treatment for Keratoconus,
using in part his peer-reviewed published study. That same recognition with HOLCOMB C3-R®
should come shortly.

While there are some doctors who have recently undertaken the Intacs® procedure, they likely do
not have the same level of experience as Dr. Brian. These doctors usually are unaware of the
rational for using 1 segment versus 2 segments of Intacs.® In addition, they often do not realize
the location for placement of Intacs® varies patient to patient. It is critical that Intacs® are rotated
and placed differently for each patient based on location and severity of keratoconus. The
question you might want to ask is: Do you want an expert who knows how to place Intacs®?

Patients fly in from all over the country all the time specifically to have Intacs® performed by Dr.
Brian, since he is the expert. He is also the only doctor in the United States performing the
companion HOLCOMB C3-R® procedure which is aimed at halting the progression of the
keratoconus condition.

You can read more about both procedures at www.KeratoconusInserts.com.

Does the Intacs® procedure alone (without HOLCOMB C3-R®) stop the progression of
keratoconus?

No. On its own, Intacs® flattens the cornea, but does not prevent the cornea from further
steepening in the future. HOLCOMB C3-R,® on its own or combined with Intacs,® is the
procedure that can stop the progression and corneal thinning. Current data shows a 99.03%
success rate of halting the progression of keratoconus after HOLCOMB C3-R®.
How long do the side effects from Intacs® last?

There are minimal side effects from Intacs.® Some patients note some light sensitivity during the
first 1-4 weeks after the procedure as well as some fluctuations of vision the first 1-3 months.

The advantage with Intacs® is that they are removable and exchangeable. There is no significant
scar tissue and the Intacs® are placed outside of the visual axis so there is no risk of scarring in
the visual axis (middle are of the cornea where light focuses through the eye). The Intacs® can
remain implanted in your eye indefinitely. They are made from a material that has been
implanted in eyes for over 50 years. Dr. Brian has even performed Intacs® on his brother-in-law
and sister-in-law, so you know Dr. Brian trusts the safety of this procedure.

We have had great success in helping to avoid or delay cornea transplants in most patients. There
are a handful of patients who had a cornea transplant after Intacs,® in these cases these patients
had very severe keratoconus and were advised to have a transplant. They decided to have Intacs®
placed to delay the need for a transplant, which in most of these cases gave the patient 1-2 years
of delaying the need for the transplant.

Can I wear contact lenses after having Intacs®?

The cornea takes time to heal. During the first month after the procedure, the Intacs® will
continue to heal and the shape of the cornea will change; meaning that your prescription may
fluctuate during this healing process. Wear glasses during the first 2-4 weeks of the healing.
After 2 weeks of healing, you can begin the process of being fit with new contact lenses. Most
often you will need to wait until one month after your procedure to resume wearing them on a
regular basis. During the rest of the three month healing process, your prescription may continue
to change; you may need several fittings to reach your final contact lens prescription. Remember,
Intacs® and HOLCOMB C3-R® procedures are performed to control your keratoconus and
patience is necessary during this important healing time.

After HOLCOMB C3-R®only (no Intacs®) you can resume use of your current contact lenses the
day after the procedure. You may need to be re-fitted for contact lenses after 3 months.

Can I come in for a free consultation for HOLCOMB C3-R® and Intacs®?

Keratoconus is a progressive medical condition that requires extensive testing through a


comprehensive examination to determine eligibility for any surgical procedures. This is a much
more detailed office visit than a free consultation. The fee for a comprehensive cornea exam with
Dr. Brian is $395.00. PPO/POS insurance plans may reimburse 40-70% of this exam to you.

How long does the exam take?

The initial exam takes about 2-3 hours. You will have extensive tests and measurements, meet
with Dr. Brian personally to discuss the test results, discuss with Dr. Brian the best procedure
option and have all your questions answered. You will complete your visit with our keratoconus
counselor who will go over pricing and scheduling questions.
How do I prepare for this procedure?

There is no special preparation for this procedure. At the time of your initial examination our
friendly keratoconus counselor will provide you with a possible list of eye drops to bring to the
day of the procedure/treatment and go over what to expect the day of your procedure.

Can you tell from my prescription if I am a candidate?

Your glasses or contact lens prescription alone is not enough information to make this important
decision; we would need to see your optometrist’s records, including color maps (topography).

Reviewing your prescription along with color cornea maps can provide preliminary decision on
whether you are might be a candidate. A concrete decision is made by a full comprehensive
testing completed in our office allowing Dr. Brian to determine the severity of your keratoconus
and location of your keratoconus.

What if I don’t live locally?

For our out of town patients we routinely offer a complimentary records review to make a
preliminary determination of candidacy. If Dr. Brian preliminarily determines that you are a
good candidate from his review of your records, you could then schedule a 3 day visit to Beverly
Hills.

During a 3 day visit to our office you can expect the following:

Day 1 – tests/measurements, review of tests/measurements & questions answered by Dr. Brian


Day 2 – treatment/procedure
Day 3 – follow-up exam; return home, yes even fly, after your follow-up exam on the 3 day

After returning home you will see a local ophthalmologist at 3 months and annually thereafter.

If you have the Intacs® procedure you can see your local eye doctor for a new contact lens or
glasses prescription 2 weeks after the procedure.

We routinely help coordinate follow doctors for out-of-town patients.

Can Keratoconus patients be candidates for Insertable Contact lens (Visian ICL™)?

Some keratoconus patients are candidates for the Visian ICL™ lens, based on stabilized
keratoconus and amount of nearsightedness. Generally, the best outcomes are with patients with
less than 5 diopters of astigmatism. Prior to the ICL™ most patients would need to undergo
Holcomb C3-R® with/without Intacs® to stabilize keratoconus 3-6 months prior to Visian ICL.™
Are there any other treatments that can improve my vision?

Dr. Brian can perform a procedure called CK® (conductive keratoplasty) to help reduce some of
the astigmatism and further improve vision. This can help improve the quality of vision and
assist with obtaining lower levels of postoperative astigmatism. This can help for fitting of soft
toric contact lenses or improving vision with RGP contact lenses. This procedure will not
permanently eliminate your need for contact lenses or glasses, but may improve the overall
quality of vision you obtain with contact lenses or glasses.

How much do the procedures cost?

Many of our patients enjoy the flexibility of financing their procedures, it’s very popular. The
monthly payments are typically about $150-200 per month for each procedure. You can learn
more about this option by visiting: www.CareCredit.com. Many patients like the option of the 24
interest free payment plan or 5 years low interest plan.

For the total procedure fees, please contact the office for a current fee schedule.

Does insurance cover Intacs®?

Patients have had some success with some PPO or POS insurance plans reimbursing patients
who pay out of pocket for a portion of the Intacs® procedure.

You would pay the full amount of the procedure at the time of service. We will provide you a
billing statement and a packet explaining medically necessity. We encourage you to submit this
to your insurance for consideration. Your insurance will review the information. If they make a
determination that you have benefits to cover this procedure, they would reimburse you directly.

Please be aware we cannot guarantee that your insurance will reimburse any portion of your
procedure. Each plan is different.

On average, patients are reimbursed around $1000/per eye. Many insurance companies equate
this procedure to a small eye procedure; so the reimbursement is rather low. In addition they may
deny, due to policy coverage only after the patient has lost their vision.

Unfortunately due to the insurance companies run around on payments we are no longer able to
directly bill your insurance.

If you want to have a preliminary idea of whether your insurance might reimburse the procedure,
you would inquire on benefits for out-patient procedures for procedure code 0099T with a
diagnosis keratoconus code of 371.60.

Regrettably, we do not have an insurance billing department so we are unable to talk to your
insurance company directly or provide them with a prior authorization request.
What do I do if my insurance company denies the Intacs® procedure?

There are excellent form letters you can use for an appeal that are posted on the Intacs®
manufacturer website – http://www.Intacsforkeratoconus.com/main/kcdenial.html

Does insurance cover HOLCOMB C3-R®?

Most insurance companies view this as preventive medicine. Therefore, they typically do not
cover the procedure. We will provide you a billing statement and a packet explaining medically
necessity. We encourage you to submit this to your insurance for consideration.

Does insurance cover CK®?

Most insurance companies view this as a vision correction procedure to reduce astigmatism.
Therefore, they typically do not cover the procedure. We will provide you with a billing
statement and a packet explaining medically necessity. We encourage you to submit this to your
insurance for consideration.

Does insurance cover the insertable contact lens (Visian ICL™)?

Most insurance companies view this as a vision correction procedure to reduce nearsightedness.
Therefore, they typically do not cover the procedure. We will provide you with a billing
statement. You can submit this to your insurance for consideration.

You fees seem higher than I expected?

After all Dr. Brian’s expertise, when he sees a patient with Keratoconus, he know exactly
what needs to be done AND how to do it - in the same way when a jet fighter pilots steps into
the cockpit, he knows what to do with the complex instrument panels of gauges, screens, and
knobs. This is where many other eye surgeons fall short – they simply don’t see that many
patients with Keratoconus.  

We could easily reduce our fees, but the question and ethical dilemma is: what do we leave out
of the process? This is how fees could be lower:

 trade in equipment for less expensive, lower quality technology that doesn’t work as well

 switch out staff for inferior ones, who wouldn’t be as accurate with measurements or
concerned about providing excellent care

 hire a junior surgeon to do the surgeries

People fly to us from all over the world for their Keratoconus treatments not because they can
easily afford to do so. They do so because it’s their eyes and they want the most experienced
surgeon who invented these Keratoconus treatments to do their surgery to get the best results.
How Holcomb C3-R® Was Developed
By Brian S. Boxer Wachler, MD

The first 1998 publication of crosslinking was with epithelium removal and it showed ability to stabilize the
disease, but it reported a painful recovery and corneal swelling side effects (future studies would show there many
more side effects from epithelium-removal crosslinking such as corneal ulcers, cornea haze, very slow recovery,
partial loss of vision, etc). Nonetheless after this publication, there was one peculiar thing: no one was performing
crosslinking. The publication was out there, but went largely unnoticed by the ophthalmology community and
medical societies. It was the equivalent of a "silent shot in the dark." I just couldn’t understand why no one else
seemed to pay any attention to this publication in 1998. It was golden.

I was fascinated when I read this study as I was already was pioneering the use of Intacs® for Keratoconus as
an alternative to invasive corneal transplants (which carry significant risks). After my own research into
crosslinking, I quickly realized that scaping off the epithelium will cause a lot of pain during the recovery and other
potential problems. I thought, "there MUST be a better way!"

I worked to develop a way to perform crosslinking WITHOUT needing to do the


invasive step of scraping off the cornea's epithelium top layer (aka transepithelial
crosslinking). After many, many nights working on this after-hours, I finally
discovered a method to obtain successful results.

Was it possible to have a completely non-invasive, epithelium-on (transepithelial)


procedure that stops Keratoconus in its tracks without the risks that epithelium
removal crosslinking inherently carries?

The answer was a resounding "YES!"

After my discovery, I could hardly sleep that night back in 2003.

I very vividly remember our first patient in January of 2004. He is a very famous
movie producer in Hollywood (due to patient privacy, I cannot mention his name, but
you would know his movies and the A-list celebrities in those movies). He
unfortunately had Keratoconus develop after LASIK done elsewhere. I explained the
nature of this new procedure that I invented. (I hadn't given it a name then).

He was open to it and trusted me.

The results were incredible: we stopped his Keratoconus from progressing and he was very happy. And best of
all: he was back at work the very next day after the procedure, no discomfort, no time off work, no change in his life.
It was amazing, just a one-day recovery.

I discussed with my wife Selina my excitement. On a plane flight with her shortly afterwards, I explained the nature
of the procedure and that it needed to have a simple name. It would be hard for people to say, “riboflavin in the
cornea for collagen crosslinking.”
A lot of good ideas have been written on the back of a napkin. I suppose we can add the naming of this procedure to
that list. Years ago I learned a process to help with creativity from the book, What a Great Idea. You draw the words
of interest in a circle and then keep looking at the words. Usually with time the solution will hit you. On the back of
a United Airlines napkin I did this with Selina at my side.

Suddenly, the name of the procedure jumped out like a jack-in-box from the circle of
words: C3-R®. There were three words with letter "C" (corneal collagen crosslinking)
and one word with "R" (riboflavin). Eventually I obtained a United States Trademark
for C3-R®.

C3-R® procedure is distinctly different from invasive epithelium removal


crosslinking and other "home grown" epithelium-on crosslinking that some other
doctors are trying to do now. I wanted to be sure we protected our established
crosslinking C3-R® brand that uses our proprietary Crosslinking Solution (that
contains riboflavin and other compounds).

By doing this, the proprietary C3-R® procedure could never be confused with less
desirable or other unproven “epi-on” crosslinking techniques. C3-R® now has over 9
years behind it – significantly longer than any other crosslinking procedure in United
States, Canada, and all countries in the world (except for Germany). And C3-R® is
ONLY available at our office.

Since 2003, people know and trust C3-R®. Why? Because it has stood the test of time and has an Olympic
Gold medal behind it.
®
[Why bother to trademark C3-R ? It's like with Coke® that is a protected brand owned by The Coca-Cola Company. When you
® ®
buy a Coke , you know exactly what you're getting. You know it won't taste different from what you expect. You know Coke is
made from the secret formula locked in a vault somewhere deep in The Coca-Cola Company headquarters in Atlanta, Georgia.
®
You know if you buy a Coke , it's not an unauthentic knockoff from another company – they can’t call their cola "Coke" because
®
The Coca-Cola Company owns the trademark for Coke . These are all the same reasons that C3-R® is trademarked (and yes,
our secret formula for our proprietary Crosslinking Solution is also locked in a vault). So that YOU know with C3-R® you
are getting the "real thing."]

After retiring from the sport of bobsled due to being legally blind from Keratoconus,
our patient Steve Holcomb, the top bobsled driver on the United States Olympic team,
regained 20/20 vision in 2007 after C3-R® and implants and made a miraculous
comeback to the sport.

At the 2010 Winter Olympics in Vancouver, history was made as Steve won the first
Olympic Gold in bobsled for the U.S. in 62 years. His story was broadcast around the
world and it created global awareness that there are minimally involved procedures,
in contrast to cornea transplants, to help people with Keratoconus.

Then on April 9, 2010 when Steve and I were on Dr. Phil's The Doctors television
show, I announced the name modification of "C3-R®" to "Holcomb C3-R®" in honor of Steve Holcomb. This marked
the first time in history that a procedure treatment was named after an Olympic athlete who made the treatment
world-famous. Because of the massive media exposure about Steve's Olympic accomplishment and his comeback
from Keratoconus, people around the world now know there are options besides invasive and painful cornea
transplants.
12 Most Common Myths
About Keratoconus and Treatments

Myth #1: “Hard contacts will prevent my Keratoconus from getting worse.”
The truth is no contact lens stops or slows down Keratoconus progression. Contacts merely sit
on top of the cornea, like a hat on your head. If your head was expanding, the hat will not stop
that expansion. Eventually you’ll need a new hat size. The same thing is with hard contact
lenses and Keratoconus. Saying hard contact lenses hold the cornea back is like saying a surfer
somehow pushes the wave back. The only means to prevent Keratoconus from progressing is
with crosslinking, namely Holcomb C3-R® – 99% of people are stabilized after just a single
treatment.

Myth #2: “Keratoconus only occurs in young people.”

Although most people diagnosed with Keratoconus are younger than 30 years old, there are
plenty of patients in their 30s, 40s, and even 50s with newly diagnosed Keratoconus. For
reasons unclear to us, Keratoconus now occurs in 1 in 500 compared to 1 in 2000 in the past.

Myth #3: “When I turn 40, my Keratoconus will stabilize on its own.”

There is no crystal ball to predict when someone’s Keratoconus will “burn out.” Sometimes it
keeps progressing until a cornea transplant is needed. If Keratoconus “burns out”, by then many
people have already lost a considerable degree of vision. It makes sense to stop the progression
and preserve vision as soon as one is diagnosed which includes children too.

Myth #4: “Holcomb C3-R® is painful and will make me have cataract sooner”

Traditional crosslinking is painful since the epithelium is scraped off. With the invention of the
non-invasive Holcomb C3-R® in 2003, our proprietary crosslinking is typically a 100% no-pain
procedure with full recovery by the very next day.

All the studies show crosslinking has no effect on cataract development later in life.

Myth #5: “If I have Intacs®, I will feel them floating around.”

Intacs® are well healed below the surface in the cornea. Intacs® are immediately locked in
place by natural tissue forces and strongly sealed by the healing process. They never “float”
around.

Patients typically do not feel Intacs® since they are positioned below the surface – you won’t
feel the Intacs® much like a dental filling is not felt because the filling is inside the tooth.
Myth #6: “Intacs® need to be replaced every few years.”

The truth is Intacs® never degrade nor wear out and don’t need to replace for those reasons.
They are stronger than the cornea and won’t break even if you get hit in the eye.

Myth #7: “If I have Intacs® alone, that will stop the progression of my Keratoconus.”

Years ago Dr. Brian discovered the power of Intacs® in reshaping Keratoconus corneas and
improving vision. However he understood that they did not strengthen the weakened collagen
fibers. That’s the reason he invented Holcomb C3-R® as a vital partner to Intacs® to stabilize
Keratoconus. When used together, Intacs® and Holcomb C3-R® can improve vision AND
stabilize Keratoconus.

Myth #8: “Intacs® and Holcomb C3-R® are too expensive and I can’t afford them.”

This probably won’t surprise you: a lot of people who can easily afford their Keratoconus
treatments secretly feel guilty about spending money on themselves rather than on their kids or
others in their lives. Well, the truth is your loved ones want you to enjoy your life. And you
certainly work hard and deserve to take care of yourself now. Going through life without seeing
as well as you can, not fully enjoying your life, hobbies, job, school, sports is just not fair. Your
Keratoconus treatments are expected to serve you the rest of your life. Depending on your
situation, your treatments could wind up costing you less than a few hundred dollars a month
through patient financing programs that we offer. You may also use your own VISA or
MasterCard. As to the cost of the procedures, it’s much more than “vitamins and light” and “a
piece of plastic”. It is the end-product of scientific research spanning more than 20 years and
requiring more than $20 million dollars. Our Intacs® and Holcomb C3-R® techniques are
“state-of-the-art”. We expect you to be amazed at how much better you see from driving
(especially night driving), seeing people’s faces, watching TV, playing sports, and weekend
activities to name a few. We expect you’ll surprise yourself and be proud to have the
procedures, proud that you did something good for your health, well-being, and your future.

Myth #9: “I can save money by going to a nearby clinic who takes insurance for Intacs®.”

There are cheap versions of every kind of medical procedure. People come to us all the time
telling us how unhappy there are that they tried to save a few dollars by going to a cheaper eye
center or one that took their insurance. You know the saying, “penny wise, pound foolish.”
When it comes to your health, you certainly don’t want a false bargain. Frankly, Intacs® and
Holcomb C3-R® are not the lowest priced Keratoconus procedures out there. They are, in fact,
premium procedures from one of the world’s leaders in Keratoconus – Brian S. Boxer Wachler,
MD. There are many reasons for our fees, including our proprietary technology, our high quality
standards, and our exceptional service for our patients. Even to the point that our patients have
Dr. Brian’s cell phone in case they need him after hours. Saving money by having cheaper
Intacs® and crosslinking is no savings at all if it fails to help your vision and your Keratoconus
or disappoints you so much you with wished you never had them performed by another doctor.
Myth #10: “My Keratoconus is too far gone and CAN’T be helped.”

In the past, many people with Keratoconus have been told – by optometrists and
ophthalmologists – that their only options were hard contact lenses or an invasive and painful
cornea transplant. This medical advice is “10 years ago” thinking and is NO LONGER TRUE
TODAY! At the Boxer Wachler Vision Institute we’ve made amazing technology advances.
Today’s Boxer Wachler Holcomb C3-R® and Intacs® help people who could not be helped
in the past! Best of all, our treatments typically give people the peace of mind of never needing
to worry about having a cornea transplant in the future.

Myth #11: “I can book my flight and hotel, fly out to Beverly Hills then be told that I’m NOT a
candidate for any procedures.”

This virtually never happens and here’s the reason: Dr. Brian routinely performs complimentary
record reviews for out-of-town patients to make preliminary recommendations regarding whether
or not you are a candidate. This gives us a 99.9% certainty that we can help you BEFORE you
arrive here - so you can confidently schedule your travel arrangements for a 3 day trip to 1) see
Dr. Brian, 2) have your Keratoconus treatments with him, and 3) have him examine you at the 1
day checkup. We will help coordinate your follow up doctor visits back home too. Patients
routinely come to us from all over the country and the world. Coordinating your aftercare back
home with a local doctor is a normal routine for us.

Myth #12: “All Intacs® and crosslinking procedures are the same.”

Do NOT make this mistake. There are no shortage of eye surgeons jumping on the “Keratoconus
bandwagon” who are now offering Intacs® and crosslinking. The Boxer Wachler Vision Institute
performs more Intacs® and crosslinking procedures every year than any of them. Simply put, no
one matches our combination of advanced technology, quality, and service. No one!

Our Holcomb C3-R® and Intacs® procedures are the result of proprietary extensive and
continuous research. You know, there are some things where quality differences don’t matter
much, but with other things, quality differences matter a lot, and I’m sure you’ll agree with that.
For example - going out for eggs and pancakes in the morning - I don’t think there’s much
difference between breakfast Denny’s or breakfast in the dining room of a fancy hotel. Price
sure is different, but well, sunny side-up eggs are sunny side-up eggs. However, there is a big
difference between a steak dinner at Denny’s or Longhorn Steakhouse, as opposed to a Morton’s
or Ruth's Chris Steakhouse. Well, when it comes to your HEALTH AND WELL-BEING, your
personal SAFETY and your overall ENJOYMENT OF LIFE, the quality, the technology, the
engineering, the function, the comfort of your Keratoconus treatments matters a lot!
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could lead to a poor outcome with decreased vision over
time (e.g. post-LASIK ectasia). This biomechanical pa-
rameter, hysteresis, together with anatomic information
from the Orbscan, may allow surgeons to more accu-
rately identify patients with weak corneas who are at
risk for a poor outcome following LASIK surgery. The
LASIK: Measuring Corneal UCLA Laser Refractive Center is the only center cur-
Biomechanics to Improve Safety rently in the area to offer this valuable diagnostic tool.
The ORA measurement is included in the complimen-
tary screening exam for refractive surgery candidates INTEGRITY INSIGHT INNOVATION
Keratoconus is a non-inflammatory corneal degenera-
tive disorder in which the cornea assumes a conical shape be- at the UCLA Laser Refractive Center.
cause of thinning and protrusion. The disorder is typically bi-
lateral, but asymmetric. The onset generally occurs at the age of
Figure 1: A signal from the Ocular Response
Analyzer. The “Pressure” curve shows the pressure ap-
More Options than Ever
The Keratoconus Renaissance Intacs and C3-R®
puberty and can continue to progress for 10-20 years. As the plied to the cornea versus time during the 25 msec air “Dr. Boxer Wachler has treated several of my
We are familiar with the Italian Renaissance that bore achievements by In another study we performed patients with C3-R. This treatment really works.
cornea steepens, irregular astigmatism, usually in conjunction puff. The “Applanation Signal” curve shows the signal Leonardo DaVinci and Michelangelo among many others. With all the treatments that evaluated the effect of single seg- Following treatment, the topographies shown in
with myopia, results. Contact lenses are the first line of treat- measured by the infrared camera system, demonstrat- now available for keratoconus, I conclude that the treatment of keratoconus is ex- ment Intacs with and without C3-R®, difference between pre- and post-operative treat-
ment. Often, however, the contact lens fit is suboptimal and ing maximal signals when the cornea is in a flattened periencing a renaissance unto itself. In the history of this disease, there are now we found that C3-R® added to the vi- ment are very impressive. There is a marked in-
crease in regularity of shape.
comfort and vision quality becomes an issue. As a result, kera- state. The difference between the maximal applanation more methods that are available for helping patients with their vision than ever sion and topography improvements When combined with Intacs, the topogra-
on the upstroke of pressure (“In” Signal Peak) and the before. compared to Intacs alone. This was phies appear much more normal in the periphery
toconus patients often seek refractive surgery as an alternative Medical Treatments: Surgical Treatments: observed in patients with stable kera- and mid-periphery, allowing for a much easier fit
to glasses and contact lenses. down stroke of pressure (“Out” Signal Peak) gives a of an appropriate soft (or RGP) contact lens. It
Soft toric contact lenses Intacs (double and single segments) toconus as well.
There is a wide variation in the clinical manifestation of measure of the corneal strength or “hysteresis”. also provides improved visual acuity for the pa-
RGP contact lenses Intacs combined with C3-R® CK (Conductive Keratoplasty) tient, both with and without contact lenses in
keratoconus. In some cases, the protrusion or ectasia develops C3-R® (corneal collagen crosslinking) CK (conductive keratoplasty) CK is a thermal procedure that place. In my experience, the actual treatments
rapidly and severely, resulting in decreased best corrected vi- Phakic Intraocular Lenses induces corneal steepening. It is (Intacs and C3-R) do not take a long time to
Halting Progression – Is it Really Possible? FDA-approved for hyperopia and manifest the improvements. Also, once the con-
sion and scarring of the apex of the cone. In many cases, how-
Weakened collagen in the cornea is “C3-R is definitely worth talking to patients presbyopia. We know from earlier tact lenses are fitted, the patients are extremely
ever, keratoconus cannot be detected by a clinical exam and the happy with their vision. I am indeed very im-
the reason that keratoconus develops. about. As an optometrist who treats keratoco- studies of CK in young patients with pressed with the results of Dr. Boxer Wachler’s
patient maintains excellent uncorrected or best corrected vision. Literally, the cone is a hernia in the cor- nus patients, I think it is important to be honest, keratoconus that there is a high like- treatments.
These sub-clinical or forme fruste keratoconus patients are the nea. It stands to reason that if a treat- and present all of the treatment modalities that lihood of regression. We have ob- I would be happy to discuss my experience
are available, even newer ones. It is our obliga-
most problematic from a refractive surgery perspective. Excimer ment could strengthen the corneal col- tion to speak to patients about all of their options. served with our prior work that ther- with co-managing C3-R patients with anyone who
is interested.” — Dr. Wes Wheadon, OD
laser refractive surgery (e.g. LASIK or PRK) removes tissue from lagen, then such a process could prevent We need to be proactive and provide the infor- mal procedures are less likely to re-
further deterioration. Such a treatment mation. Patients will greatly benefit from hearing gress in young patients
the cornea. A cornea that is inherently weak may become even exists. It’s called C3-R®. C3-R® is a non- information from their doctor directly rather than who have had C3-R® to
weaker following LASIK, leading to more rapid progression of stumbling across it on the web, or hearing it from
invasive, one-time procedure where only friends. I even Xerox recent publications and pro- strengthen the cor-
the disorder. Newer corneal topography machines, such as the topical drops of special of riboflavin so- vide them for my patients who are doing their neas. We are now us-
Orbscan and Pentacam, provide imaging of the posterior sur- lution are applied to the cornea which is research on available treatments, because it ing a unique form of
face of the cornea which may aid in the diagnosis of subtle forme Figure 2: Studies have shown a difference in the ORA then exposed to a low amount of ultra- shows that I am acting on behalf of their best CK to address high
interests.
signal from keratoconus, Fuchs’ dystrophy and normal violet-A light. (This procedure was origi- C3-R is a viable option for patients with com-
astigmatism in patients
fruste keratoconus. In addition, a brand new diagnostic instru- nally developed by dermatology research- promised corneas. In a relatively straightforward who have keratoconus
ment called the Ocular Response Analyzer (Reichert, Inc.) pro- populations. (courtesy Reichert, Inc.)
ers as a way to increase skin collagen.) case, Dr. Boxer Wachler was able to treat my and who have had C3-
vides a measure of corneal biomechanics that may further aid The activated riboflavin enhances cor- patient successfully and he is very satisfied with R ® to reduce regres-
surgeons in the diagnosis of subtle forme fruste keratoconus. neal strength and integrity by increasing his results. — Dr. Cecelia Perez, OD sion. The specialized
Surgeons at the UCLA Laser Refractive Center have in- collagen cross-linking and collagen fiber diameter. This has been proven experimen- CK technique involves
tally and published in the peer-reviewed literature. The first patients were treated 8 steepening the flat area
corporated the Ocular Response Analyzer (ORA) into the LASIK
years ago and there have been no reported complications. It is effective in halting the of topography which is
screening process to improve decision making as to patient can- progression of keratoconus. The 30-minute procedure is performed in our office and the complement to the
didacy for the procedure. The ORA measures the biomechanics the day after the procedure, patients can return to work and can resume contact lens or Intacs effect that flat-
or “hysteresis” of the cornea by applying a 25 millisecond puff glasses wear. tens the steep area of the topography.
of air that presses on the cornea in a controlled fashion. Infra- The C3-R® therapy is safe since the riboflavin absorbs the ultraviolet light in the cor- Phakic Intraocular Lenses (IOLs)
red cameras monitor the flattening and concavity of the cornea nea thereby preventing transmission of light past Descemet’s membrane. The crystalline For patients with high myopia from keratoconus, phakic IOLs are an effective
lens and retina are not affected so there are no complications from this treatment. alternative to reduce the burden of high myopia on their contact lenses or glasses.
caused by the air puff over time (Figure 1). The pressure re- Intacs – 1 or 2 Segments? The quality of vision is often better when high myopia is corrected closer to the
quired to flatten the cornea on the inward pressure curve is com- We have a study that is accepted for publication that evaluated that question: nodal point inside the eye as occurs with an IOL. There are two FDA-approved
pared to the pressure measured when the cornea flattens on which gave better results for keratoconus - placement of one or two segments? We phakic IOLs for high myopia: Verisyse lens (made by AMO) and Visian ICL (made
the outward pressure curve. The difference between these 2 found that better corneal and vision changes were found with single segments. We by Staar). Following the procedure, patients can wear either glasses (much weaker
If you have questions about this article or need further discovered placement of a single segment not only flattens the cone in the lower prescription) or contact lenses for residual refractive error.
readings is a measure of the corneal hysteresis or strength. A
information, please contact the UCLA Laser Refractive topography, but also has the unique effect of steepening the upper cornea, which is Conclusion
larger hysteresis indicates a cornea with stronger biomechani-
Center at lrc@jsei.ucla.edu, or 310.UCLASER / relatively flat, like a shelf (Figure 1). Placing two segments leads to unnecessary In my opinion, the year 2006 represents the birth of the renaissance of treat-
cal properties. The distribution of hysteresis measurements in flattening of the upper cornea that is already flat. Single segments have an ideal ments for patients with keratoconus. More information about C3-R®, Intacs, CK
310.825.2737.
keratoconus eyes is distinctly different from that of normal eyes effect on both lower and upper topography regions and produce better corneal op- and phakic IOLs for keratoconus can be found at www.keratoconusinserts.com or
(Figure 2), suggesting hysteresis may be a useful parameter to UCLA LASER REFRACTIVE CENTER, 100 STEIN PLAZA
tics than double segments. If patients are experiencing suboptimal results with two www.boxerwachler.com.
aid in the screening process. segments, the upper segment can be removed to obtain the effect of a single segment.
– UCLA, LOS ANGELES, CA 90095
A cornea that is inherently weak preoperatively may PHONE 310.UCLASER / 310.825.2737, ROXSAN MEDICAL BUILDING, NINTH FLOOR 465 N. ROXBURY DRIVE, SUITE 902 BEVERLY HILLS, CA 90210
PHONE 310.860.1900 FAX 310.860.1902 BBW@BOXERWACHLER.COM WWW.BOXERWACHLER.COM
become significantly weaker following LASIK surgery which LRC@JSEI.UCLA.EDU, WWW.UCLASER.COM © Boxer Wachler Vision Institute, Inc., Medical Associates

6
COVER STORY

Corneal Collagen
Crosslinking
With Riboflavin
A new treatment to strengthen the cornea for keratoectasia and keratoconus.
BY BRIAN S. BOXER WACHLER, MD

he weakened cornea is one of the most challenging though Intacs have been a powerful tool, these ring seg-

T conditions for surgeons to recognize prior to per-


forming LASIK or to treat after LASIK. Naturally
occurring keratoconus can be equally challenging
to manage.
ments have limitations. First, Intacs do not affect the bio-
chemical substance of the corneal tissue. Second, there is
a limit to how much corneal flattening (reversal of kera-
toectasia and keratoconus) the segments can achieve.

BACKGROUND CORNEAL COLLAGEN CROSSLINKING WITH


To understand how to strengthen the cornea, one RIBOFLAVIN
must understand how the cornea becomes weakened by About the Procedure
keratoectasia and keratoconus. Young patients have a A new treatment for keratoconus increases collagen by
propensity to produce high levels of reactive oxygen applying a one-time-only topical dose of riboflavin drops to
species (free radicals) in the cornea. Superoxide dismu- the cornea and exposing the cornea to a low amount of
tase and other enzymes typically prevent the accumula-
tion of these free radicals. Some patients are unable to
produce these protective enzymes, however. As a result,
the free radicals accumulate, causing damage to the
structural integrity of the cornea.1,2 Corneal thinning and
weakening can ensue, and the cornea may herniate and
steepen due to the biomechanics of IOP-induced strain
on the tissue. In other words, keratoconus develops. Out-
lining this process illustrates why my colleague and I have
been able to reverse early ectasia only by lowering IOP
with glaucoma drops.3
Free radicals in the cornea have been shown to increase
with exposure to sunlight and eye rubbing.4 Ophthalmol-
ogists therefore recommend that all patients with kerato-
conus wear sunglasses outside and avoid rubbing their eyes.

INTACS
Surgeons such as myself have found Intacs (Addition Figure 1. Combining corneal collagen crosslinking with ribo-
Technology, Inc., Des Plaines, IL) to be useful for reversing flavin and the placement of Intacs produced 10.00D of cor-
some of the effects of keratoectasia and keratoconus.5 Al- neal flattening in this case of keratoconus.

JANUARY 2005 I CATARACT & REFRACTIVE SURGERY TODAY I 73


CRSToday.com ultraviolet A (UVA) light.6 The activated riboflavin enhances corneal strength and
integrity by increasing collagen crosslinking, as proven experimentally and published
CRSToday.com in the peer-reviewed literature.7,8
This riboflavin/UVA therapy has been safe thus far. There have been no report-
ed complications in the crystalline lens or retina due to the limitation of UVA
transmission through the cornea. In a 3-year study of patients with actively pro-
CRSToday.com gressing keratoconus, the pattern of increasing mean keratometry values was not
only halted, but it was also reversed and flattened by a mean of 2.00D. That result
persisted during the 3-year follow-up period.6

CRSToday.com My Experience
In early January 2004, we began using riboflavin/UVA treatments in patients with
compromised corneal integrity. We named the modified procedure C3-R (corneal

CRSToday.com collagen crosslinking with riboflavin). The causes of reduced corneal integrity in our
treated patients included LASIK-induced ectasia and keratoconus. To our knowl-
edge, these C3-R procedures represent the first riboflavin/UVA treatments per-
formed in North America for keratoconus, and our C3-R treatments combined
CRSToday.com with the prior and simultaneous placement of Intacs constitute the first-ever such
treatments. The C3-R treatment is a one-time, 30-minute procedure. To date, we
have not found it necessary to repeat it.
In our patients with progressive corneal steepening from both keratoectasia and
CRSToday.com keratoconus, progression has halted. In those with prior Intacs placement whose
corneal steepening has continued to progress due to active keratoconus, we have
observed the same halting pattern. In some cases, we saw not only stabilization

CRSToday.com but also a reversal of corneal steepening as early as 1 day postoperatively that per-
sisted on subsequent follow-up visits. In cases of Intacs insertion for keratoconus
followed immediately by C3-R treatment on the same day, we observed more than
10.00D of corneal flattening in some cases, a greater degree of flattening than with
CRSToday.com Intacs alone (Figure 1).

CONCLUSION
C3-R treatments alone and combined with Intacs implantation are allowing pa-
CRSToday.com tients better and easier contact lens fittings (RGP and soft toric) as well as improved
vision and comfort. The ability to permanently strengthen the inherently weakened
cornea is a major advance in the management of these cases. C3-R treatments pro-
vide real hope for many patients with keratoectasia and keratoconus. My colleagues
CRSToday.com and I are currently compiling longer-term results of the procedure. ■

Brian S. Boxer Wachler, MD, is Director of the Boxer Wachler Vision In-

CRSToday.com stitute in Beverly Hills, California. He states that he holds no financial interest
in the products, technologies, or companies mentioned herein. Dr. Boxer
Wachler may be reached at (310) 860-1900; bbw@boxerwachler.com.

CRSToday.com
visit www.crstoday.com
1. Brown DJ, Lin B, Chwa M, et al. Elements of the nitric oxide pathway can degrade TIMP-1 and increase gelatinase activity. Mol Vis.
2004;10:281288.
2. Buddi R, Lin B, Atilano SR, et al. Evidence of oxidative stress in human corneal diseases. J Histochem Cytochem. 2002;50:341-351.
3. Hiatt J, Boxer Wachler BS. Reversal of LASIK-induced ectasia with intraocular pressure reduction. Paper presented at: The
ASCRS/ASOA Symposium on Cataract, IOL and Refractive Surgery; May 3, 2004; San Diego, CA.
4. Kenney C. Role of oxidative stress in keratoconus. Paper presented at: The University of California–Irvine Ophthalmology Meeting;

CRSToday.com February 7, 2004; Irvine, CA.


5. Boxer Wachler BS, Christie JC, Chou B, et al. Intacs for the treatment of keratoconus. Ophthalmology. 2003;110:1031-1040.
6. Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-A-induced collagen crosslinking for the treatment of keratoconus. Am J
Ophthalmol. 2003;135:620-627.
7. Wollensak G, Spoerl E, Seiler T. Stress-strain measurements of human and porcine corneas after riboflavin-ultraviolet-A-induced
cross-linking. J Cataract Refract Surg. 2003;29:1780-1785.

CRSToday.com 8. Wollensak G, Wilsch M, Spoerl E, Seiler T. Collagen fiber diameter in the rabbit cornea after collagen crosslinking by riboflavin/UVA.
Cornea. 2004;23:503-507.
Page 1 of 4

PRIMARY CARE OPTOMETRY NEWS 6/1/2006


Surgical treatment of keratoconus can restore functional
vision
C3-R with Intacs, phakic IOLs, wavefront-guided correction and DLK are new options.

Marc Bloomenstein, OD

There is a tremendous sense of comfort when a treatment is established for a condition that at one
time was thought to have no possible resolution. Moreover, when a surgically induced event leaves
the patient with few options short of a full corneal transplant, it makes our jobs easier to know a
treatment exists that may be beneficial.

For years, we have had to watch as our keratoconus patients’ vision slowly degraded to a level
where their contact lenses or glasses gave only grief instead of visual restoration, leaving us with
only one option — penetrating keratoplasty (PK). The same can be said of an eye that has pellucid Marc
marginal degeneration or, even more devastating, an ectatic cornea following refractive surgery. Bloomenstein
However, there is surgical relief in sight for these patients that may help to restore some quality of
vision, or at the very least allow for more functional vision without resorting to a PK.

Corneal thinning disorders

The incidence of keratoconus in Americans is about 1 in 2,000, or 0.05% of the population. This naturally occurring
ectasia of the cornea is correlated with a progressive thinning and ultimate steepening of the cornea to produce
myopia, irregular astigmatism and, eventually, loss of best-corrected visual acuity (BCVA). Keratoconus has a genetic
predisposition and is associated with Down’s syndrome, contact lens wear and connective tissue disorders. Pellucid
marginal degeneration and keratoglobus are other non-inflammatory corneal thinning disorders.

Refractive surgery-induced ectasia behaves in a manner similar to keratoconus, with a mean development time of
approximately 7 months. The exact biomechanical nature of this type of steepening is unclear. Arguably, this is the
most serious complication that can occur following refractive surgery, with incidence rates between 0.032% and 0.12%
reported in the literature. Therefore, treatment of ectasia will most definitely involve abstinence of surgery on any eye
that has the slightest risk of creating a thinner-than-average cornea.

It is widely held that the cornea should have a minimum of 250 µm in the bed of the stroma after LASIK. While this
holds true in most cases, ectasia still occurs after an uneventful surgery with plenty of corneal thickness. The post-
surgical patient is more apt to attempt more surgery to alter this unfortunate event than to be satisfied with glasses or
contacts.

Intacs improve VA in keratoconus

In the treatment of keratoconus, intrastromal corneal rings (Intacs, Addition Technology, Des Plaines, Ill.) act as a
passive spacing element that shortens the arc length of the anterior corneal surface and thereby flattens the central
cornea. The application of the two Intacs segments to the eye elevates the inferior ectasia and flattens the soft,
keratoconic corneal tissue, thus decreasing the asymmetric astigmatism induced by keratoconus. This procedure is
not intended to cure the keratoconus, but rather to lessen the associated corneal abnormality and improve the visual
acuity of the patient.

Ultimately, the goal of this treatment is to delay or eliminate the need for a PK. The use of these segments, as well as
the use of Ferrara intrastromal corneal rings (Ferrara Ophthalmics, Belo Horizonte, Brazil), has been demonstrated by

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Page 2 of 4

numerous peer-reviewed studies, including that of a 74-eye study by Brian S. Boxer Wachler, MD, Los Angeles (Boxer
Wachler BS, Christie JP, Chandra NS, et al. Intacs for keratoconus. Ophthalmology. 2003; 110(5):1031-1040).

Using the commercially available three-ring segment sizes of 0.25 mm, 0.30 mm and 0.35 mm, the authors concluded
that asymmetric implantation of Intacs can improve uncorrected visual acuity (UCVA) and BCVA, as well as provide a
clinically significant reduction in irregular astigmatism in keratoconic corneas with and without corneal scarring. They
found that patients with lower degrees of preoperative cylinder tended to experience better improvement in UCVA. Dr.
Boxer Wachler was able to improve 41% of the eyes by at least two lines of BCVA, with 66% achieving the same with
UCVA postoperatively.

The investigators found that eyes with better preoperative BCVA attained superior BCVA postoperatively. However,
those eyes with worse preoperative acuity often experienced the greatest improvements.

It is important to inform patients that treatment may not succeed in a small percentage of cases. However, Intacs are
minimally invasive (especially with the addition of IntraLase [Irvine, Calif.] to create the channels for the Intacs
insertion) and reversible, which enables patients to have high risk-to-benefit ratios.

C3-R with Intacs: These corneal topography maps show the pre- and 1-month post-
Intacs plus C3-R treatments for keratoconus, which were performed on the same
day. Note the nearly 10 D of flattening, which is more than either procedure can
achieve individually.

Image: BS Boxer Wachler

Risks with Intacs

As with any surgery, risks are associated with placing Intacs in an eye, regardless of the keratoconic status.
Postoperatively, residual irregularity may induce glare or halos. Some neovascularization may develop toward the
incision, especially in long-term contact lens patients. The vessels are most often seen at the 12-o’clock position and
necessitate an anti-inflammatory to reduce their progression. On rare occasions, the vessels will need to be
cauterized.

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Page 3 of 4

Intacs in conjunction with C3-R

The most critical issue with this treatment is stability, and although good data support its permanence, prevention of
long-term progression is in question. This is why surgeons are combining Intacs with corneal collagen cross-linking
with riboflavin, or C3-R.

The C3-R works by increasing collagen cross-linking, the natural “anchors” within the cornea. Custom-made riboflavin
eye drops are applied to the cornea, which is then activated by a low-level ultraviolet A (UVA) light. The process has
been shown in laboratory and clinical studies to increase the amount of collagen cross-linking in the cornea and
strengthen the tissue. In published European studies, such treatments were proven safe and effective in patients.

C3-R treatments prevent keratoconus from worsening, as well as help the Intacs reverse the keratoconus steepening
that occurred prior to the treatment. The use of C3-R may also be beneficial in treating postoperative ectasia and in
progressive radial keratometry patients. Because both procedures leave the cornea in a position of weakening, the
use of riboflavin/UVA treatment can help reverse that trend.

The safety and predictability of the riboflavin/UVA will be borne out in the coming months to years as more patients
undergo this treatment. Furthermore, Intacs placement is safe and effective; however, the change in astigmatism
correction is unpredictable, and the patient needs to be aware that this is not a panacea.

Phakic IOLs

The recent FDA approval of the second phakic intraocular lens (PIOL), the
Visian from STAAR Surgical (Monrovia, Calif.), is a start in the direction of
another surgical treatment for keratoconus in this country. Although the
Verisyse (AMO, Irvine, Calif.) and the Visian are approved only for spherical
myopia, the general acceptance and patient satisfaction should lead to a quick
approval of the toric PIOL.

In fact, in European contact lens-intolerant keratoconic patients, the


implantation of the PIOL has been shown to reduce myopic astigmatism to a
functional level. While this treatment does not attempt to stabilize the cornea
or reverse the ectatic trend, it helps bridge the time between contact lens
intolerance and PK. The permanent yet reversible nature of the PIOL lends
itself to an excellent surgical option.

Wavefront-guided keratoconic correction

Research has begun to evaluate the use of wavefront-guided treatment for the
correction of keratoconic symptoms. The use of laser to treat a condition that
has always been considered contraindicated is obviously contentious.
However, recent studies have demonstrated that wavefront treatment-guided
surface ablation may be appropriate for use in patients with significant coma
and trefoil due to keratoconus.

Investigators evaluated the wavefront-guided treatment in 56 patients with


average higher-order aberrations of 0.37 µm and with an average spherical
equivalent of –3.15 D (Preliminary study shows wavefront treatment helps
patients with keratoconus. Ocular Surgery News Supersite, April 27, 2005). The preliminary results showed that all
patients had achieved 20/40 or better UCVA; 92% achieved 20/25 or better UCVA; and an astounding 80% achieved
20/20 or better UCVA. These early results indicate that wavefront-guided surface ablation may at some time be a
viable option to help treat keratoconus patients. However, these are very early results, and more long-term data are
necessary to see how well this treatment modality will hold up as the biomechanics of the cornea change.

Deep lamellar keratoplasty preserves epithelium

When these relatively noninvasive procedures fail to provide any visual relief to the patient, corneal transplant may be
the only option left. Surgeons are now looking at deep lamellar keratoplasty to preserve the patient’s endothelium.

Endothelial rejection is the primary disadvantage of PK. Recently, deep lamellar keratoplasty techniques have
improved so that a full-thickness corneal stroma and epithelial button may be placed into a host bed containing little or

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Page 4 of 4

no stromal tissue on top of Descemet’s membrane. Deep lamellar keratoplasty seems to offer vision equivalent to PK,
with fewer treatment failures because of endothelial rejection, less endothelial cell loss and a reduced need for great
vigilance by both patient and physician postoperatively.

Deep lamellar keratoplasty reduces endothelial cell density by approximately 10% from preoperative levels and by half
as much as PK. The use of air bubbles as a means to dissect the cornea at the pre-Descemet’s plane has proven to
make Descemet’s membrane safer in high-risk patients, although the procedure does become time consuming.

Contacts first line of defense

Contact lenses are the first line of defense in these distorted corneas. The surgical treatment of keratoconus obviously
depends on the severity of the corneal distortion, contact lens intolerance and the patient’s motivation. Intacs with C3-
R currently appears to provide an opportunity for some keratoconics to avoid a keratoplasty while maintaining
functional vision. The reversible nature and avoidance of the central cornea also makes Intacs a safe surgical option.
Other patients may opt to wait for newer procedures, such as toric PIOLs or customized toric IOLs for treatment of the
ectasia.

As our knowledge of the biomechanics of the cornea expands, it is hoped that we can add these ectatic conditions to
the list of treatable diseases.

For more information:

z Marc Bloomenstein, OD, FAAO, is a member of the Editorial Board of Primary Care Optometry
News and refractive clinic medical director at Barnet Dulaney Perkins Eye Center in Phoenix.
He can be reached at 4800 N. 22nd St., Phoenix, AZ 85016; (602) 955-1000; fax: (602) 508-
4744; e-mail: Mbloomenstein@BDPEC.com. Dr. Bloomenstein has no direct financial interest in
the products mentioned in this article, nor is he a paid consultant for any companies mentioned.

Copyright ® 2010 SLACK Incorporated. All rights reserved.

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J CATARACT REFRACT SURG - VOL 33, JANUARY 2007

Effect of inferior-segment Intacs with and


without C3-R on keratoconus
Colin C.K. Chan, MD, FRANZCO, Munish Sharma, MD, MBBS, Brian S. Boxer Wachler, MD

PURPOSE: To determine whether corneal collagen cross-linking with riboflavin (C3-R) augments the
effect of inferior-segment Intacs (Addition Technology) in the treatment of keratoconus.
SETTING: Private practice, Beverly Hills, California, USA.
METHODS: A retrospective nonrandomized comparative case series comprised 12 eyes of 9 patients
who had inferior-segment Intacs placement without C3-R (Intacs-only group) and 13 eyes of 12 pa-
tients who had inferior-segment Intacs placement combined with C3-R (Intacs with C3-R group).
The 2 groups were matched preoperatively. All patients had inferior-segment Intacs placed with
the incision in the steep axis of manifest refraction. Corneal collagen cross-linking with riboflavin
was performed after the Intacs segments were inserted. Outcome measures were topographic kera-
tometry values and the lower–upper (L–U) ratio, which is a topographic measure of the degree of
keratoconus. Preoperative data were compared to results 1 day postoperatively and measurements
at the last postoperative visit.
RESULTS: The Intacs with C3-R group had a significantly greater reduction in cylinder than the Intacs-
only group (P<.05). Steep and average keratometry were reduced significantly more in the Intacs with
C3-R group (P<.05). There was a greater reduction in L–U ratio in the Intacs with C3-R group (P<.05).
CONCLUSION: The addition of C3-R to the Intacs procedure resulted in greater keratoconus improve-
ments than Intacs insertion alone.
J Cataract Refract Surg 2007; 33:75–80 Q 2007 ASCRS and ESCRS

Animal and human studies show that corneal collagen PATIENTS AND METHODS
cross-linking with riboflavin (C3-R) increases the mechan- In a retrospective study, 25 eyes of 21 patients with keratoco-
ical rigidity of corneas and halts the progression of kerato- nus were evaluated. Two treatment groups were compared: Intacs-
conus.1–6 It is one of the first treatments for keratoconus only and Intacs with C3-R. In the latter group, the 2 procedures
that addresses the underlying cause of corneal weakening. were performed sequentially on the same day. The groups were
Wollensak et al.1 report that corneal collagen cross-linking matched based on preoperative uncorrected visual acuity
(UCVA), best corrected visual acuity (BCVA), manifest cylinder,
leads to a mean of 2.00 diopters (D) of topographic flatten-
manifest sphere, keratometric values (K steep, K flat, and K aver-
ing. Implantation of Intacs segments (Addition Technol- age) from corneal topography (Marco ARK-9000), and lower–
ogy) is another modality that is useful in mechanically upper (L–U) ratio values (PO.05) (Table 1). The Intacs-only
flattening a portion of the cone. Based on these findings, group consisted of 12 consecutive eyes of 9 patients and the Intacs
we combined the Intacs and C3-R procedures and evalu- with C3-R group, of 13 consecutive eyes of 12 patients. Institu-
tional review board approval for the study was obtained.
ated the presence of a synergistic flattening effect in pa-
tients with keratoconus.
Surgical Technique
Accepted for publication September 25, 2006. The same surgeon (B.B.W.) performed all surgeries using
From a private practice, Beverly Hills, California, USA. a standardized technique. Inferior-segment Intacs segments were
placed with the incision in the positive cylinder axis of manifest
Dr. Boxer Wachler has a financial interest in C3-R. Drs. Chan and refraction. In the Intacs with C3-R group, a 0.35 mm segment
Sharma have no financial or proprietary interest in any method was used in 69% of cases (0.30 mm, 15%; 0.25 mm, 15%). In
or material mentioned. the Intacs-only group, a 0.35 mm segment was used in 67% of
Corresponding author: Brian S. Boxer Wachler, Boxer Wachler cases (0.30 mm, 17%; 0.25 mm, 17%). In the Intacs with C3-R
Vision Institute, 465 North Roxbury Drive, Suite 902, Beverly Hills, group, C3-R was performed immediately after the Intacs proce-
California 90210, USA. E-mail: bbw@boxerwachler.com. dure under topical anesthesia. The C3-R procedure (supplies

Q 2007 ASCRS and ESCRS 0886-3350/07/$-see front matter


Published by Elsevier Inc. doi:10.1016/j.jcrs.2006.09.012

75
KERATOCONUS AND INFERIOR-SEGMENT INTACS

Table 1. Calculation of L–U and I–S ratios.

Degrees K-Value at 3.0 mm Zone Ratios


0 49.45 MRx L–U ratio:
30 47.21 Upper Z 44.94 C 43.26 C 42.25 C 42.09 C 43.15 Z 215.69
60 44.94 Lower Z 49.45 C 50.91 C 50.88 C 49.15 C 46.91 Z 247.30
90 43.26 Lower–Upper Z 31.61 D
120 42.25
150 42.09 I–S ratio:
180 43.15 Superior Z 47.21 C 44.94 C 43.26 C 42.25 C 42.09 Z 219.75
210 44.77 Inferior Z 44.77 C 46.91 C 49.15 C 50.88 C 50.91 Z 242.62
240 46.91 Inferior–Superior Z 22.87 D
270 49.15
300 50.88
330 50.91
I–S Z inferior–superior; L–U Z lower–upper; MRx Z manifest refraction
MRx: 3.00 C2.00  40; closest 30 degrees Z 30 degrees Z L–U reference axis
I–S ratio: axis Z 180 degrees

obtained from Priavision) consisted of a 30-minute application of accurate than the L–U ratio based on autorefraction and signifi-
ultraviolet-A (UVA) light (3.0 mW/cm2 at 370 nm) to the central cantly more accurate than the I–S ratio after changes in kerato-
7.0 mm of the cornea combined with topical application of ribo- conic eyes (unpublished data). Table 1 shows an example of
flavin solution (0.1% riboflavin-5-phosphate and dextran) every calculating I–S and L–U values in the same cornea. Because the
3 minutes, similar to the technique described by Wollensak cone is oblique (not directly inferior), I–S ratio yields an artifi-
et al.1 except the corneal epithelium was not removed before treat- cially lower value than L–U ratio, which takes the meridian of
ment. The epithelium was not removed as experience showed an the cone into account.
intact epithelium leads to less patient discomfort after the proce- SPSS statistical software (SPSS, Inc.) was used for statistical
dure. Our experience with C3-R and intact epithelium has shown analysis. A paired Student t test was used for comparisons.
equal effectiveness and safety as the procedure performed with ep-
ithelial removal. To compensate, the eye was presoaked with ribo-
flavin for 5 minutes before UVA light was applied; riboflavin RESULTS
penetration of the stroma was confirmed at the slitlamp. An eyelid Preoperatively, the 2 groups were matched (Table 2).
speculum was used to expose the eye. Standard examinations,
including corneal topography and manifest refraction, were Although the UCVA and K-values were worse in the In-
conducted preoperatively and postoperatively. At the end of tacs-only group, the difference was not statistically signifi-
the C3-R procedure, we noted at slitlamp examination that the cant. The Intacs with C3-R group had more manifest
flouroscein-riboflavin solution penetrated to 50% corneal depth. cylinder, which was also not statistically significant. The
mean age of the patients was 44 years G 15 (SD) in the In-
tacs-only group and 36 G 10 years in the Intacs with C3-R
Outcome Measures and Statistical Analysis
group. The female-to-male ratio was 1:6 and 1:7, respec-
Outcomes measures included cylinder, visual acuity, kerato- tively. The mean preoperative central pachymetry was
metric outcomes, and the L–U ratio. The L–U ratio, an advanced 487 G 51 mm in the Intacs-only group and 496 G 53 mm
modification of the inferior–superior (I–S) ratio, resulted from an in the Intacs with C3-R group. The mean follow-up was
observation that most cones are not inferiorly centered but often
are located obliquely. The I–S ratio is calculated using the 180-de- 102 G 39 days and 97 G 38 days, respectively. Postopera-
gree meridian to divide the cornea into halves; however, with an tively, there were no complications in either group.
oblique cone, some steep points may inadvertently be included The Intacs with C3-R group had improved outcomes
in the superior half of the cornea, which is assumed to be flatter compared to the Intacs-only group (Table 3). There was
(Figure 1). The L–U ratio differs in that instead of the 180-degree significantly greater flattening in K steep and K average in
axis, the positive cylinder refractive axis obtained by manifest re-
fraction or autorefraction acts as the reference meridian to divide the Intacs with C3-R group than in the Intacs-only group
the cornea into halves. Therefore, the L–U reference meridian is (P!.05) (Figure 2). The manifest cylinder reduction was
specific to each eye based on the manifest or autorefraction axis. also significantly greater in the Intacs with C3-R group
The L–U ratio is then calculated by subtracting the sum of the 5 (P!.05). Both results were reflected in the L–U ratio
upper keratometric values from the sum of the 5 lower keratomet- changes, which showed a greater change (postoperative im-
ric values. The keratometric values are measured 30-degrees apart
starting at 0 degree at a 1.5 mm radius (3.0 mm zone), with values provement in corneal asymmetry of cone) in the Intacs with
rounded to the closest 30 degrees. In this study, the L–U ratio C3-R group (P!.05). The changes in BCVA and UCVA were
based on manifest refraction was used as it is slightly more not statistically significantly different between the 2 groups.

76 J CATARACT REFRACT SURG - VOL 33, JANUARY 2007


KERATOCONUS AND INFERIOR-SEGMENT INTACS

Table 2. Preoperative matched parameters.

Mean G SD
Preop
Measurement Intacs with C3-R Intacs Only
UCVA (logMAR) 1.20 (20/250) G 1.00 1.31 (20/400) G 0.81
BCVA (logMAR) 0.27 (20/40) G 0.18 0.27(20/40) G 0.18
Sphere 1.33 G 2.77 0.93 G 3.39
Cylinder 4.98 G 1.67 3.61 G 1.43
K steep (D) 48.49 G 3.36 49.84 G 5.02
K flat (D) 44.46 G 2.10 45.44 G 3.12
K average (D) 46.32 G 2.84 47.73 G 3.89
MRx L U (D) 29.63 G 20.88 23.02 G 19.13
BCVA Z best corrected visual acuity; C3-R Z corneal collagen cross-
linking with riboflavin; I–S Z inferior–superior; L–U Z lower–upper;
MRx Z manifest refraction; UCVA Z uncorrected visual acuity

Table 3. Change after treatment.

Mean Change G SD
Value Intacs with C3-R Intacs Only P Value
UCVA (logMAR) 0.76 G 0.80 0.93 G 0.89 .65
(6.5 lines) (9.5 lines)
BCVA (logMAR) 0.11 G 0.12 0.13 G 0.20 .73
(1 line) (1 line)
Sphere 0.12 G 1.72 0.25 G 2.12 .66
Cylinder 2.73 G 1.87 1.48 G 1.17 .04*
K steep (D) 1.94 G 1.32 0.89 G 2.07 .03*
K flat (D) 1.05 G 1.31 0.64 G 2.40 .16
K average (D) 1.34 G 1.27 0.21 G 2.70 .04*
MRx L–U (D) 11.23 G 24.40 6.87 G 14.90 .04*
BCVA Z best correct visual acuity; C3-R Z corneal collagen crosslinking
with riboflavin; I–S Z inferior–superior; L–U Z lower–upper; MRx Z man-
ifest refraction; UCVA Z uncorrected visual acuity
*Statistically significant

Figure 1. Comparison of how I–S and L–U measure an oblique cone. A:


The topography shows that point 1 is steep and would be used for calcu-
lation as part of the 5 superior (black dots), assumed flatter, portion of the
I–S ratio. B: The topography would allow steeper point 1 to be correctly
used in calculation of the lower (white dots), assumed steeper, component
of the L–U ratio.

DISCUSSION
Intacs insertion is now a well-established procedure for
the treatment of keratoconus.6–10 Intacs segments cause
mechanical flattening of the cone, reducing myopia; how-
ever, they cannot stop further progressive ectasia because
progressive changes are the result of weakened collagen Figure 2. Changes in K steep, K flat, and K average in the 2 treatment
that leads to the herniation of the cone. There is increasing groups. The change in K steep and K average was significantly greater
evidence that collagen weakening is caused by oxidative in the Intacs with C3-R group.

J CATARACT REFRACT SURG - VOL 33, JANUARY 2007 77


KERATOCONUS AND INFERIOR-SEGMENT INTACS

Figure 3. Preoperative (lower left), postoperative


(upper left), and difference (right) corneal topog-
raphy maps after single Intacs placement. On
the difference map, note that steepening of the
superior half of the cornea as well as flattening
of the inferior half occur. This improves the pre-
operative corneal asymmetry, resulting in
a more normalized postoperative topographic
pattern. This is a unique effect of single-segment
placement; double-segment placement leads to
flattening in both lower and upper areas of to-
pography (global flattening).

Figure 4. Preoperative (lower left), postoperative


(upper left), and difference (right) corneal topog-
raphy maps of single Intacs combined with C3-
R. Note marked flattening with a change in K
power of 4.86 D, shown on the difference map.

78 J CATARACT REFRACT SURG - VOL 33, JANUARY 2007


KERATOCONUS AND INFERIOR-SEGMENT INTACS

Figure 5. Preoperative (lower left), postoperative


(upper left), and difference (right) corneal topog-
raphy maps of C3-R alone show inferior flatten-
ing and superior steepening.

Figure 6. Preoperative (lower left), postoperative


(upper left), and difference (right) corneal topog-
raphy maps of C3-R alone. Similar to Figure 3,
C3-R alone resulted in an apparent targeted flat-
tening over the cone, which is most evident in
the difference map.

J CATARACT REFRACT SURG - VOL 33, JANUARY 2007 79


KERATOCONUS AND INFERIOR-SEGMENT INTACS

stress from abnormal processing of free radicals and super- This study has limitations. We did not assess contrast
oxides.11–13 sensitivity, nor were patient surveys administered. Al-
In a previous study,7 we noted that placement of infe- though this study’s intent was not to evaluate stabilization
rior-segment Intacs alone was more suitable than double- of keratoconus from the combined treatment over time,
segment Intacs insertion for peripherally located cones based on our results such studies are indicated in the future.
because such corneas were not only steep inferiorly but The combination of C3-R with Intacs led to better re-
also flatter superiorly. Placement of a single segment led sults than Intacs insertion alone as evidenced by greater re-
to inferior flattening and yielded a unique effect in the up- ductions in manifest cylinder, K steep, K average, and the
per cornea: superior steepening (Figure 3). Superior steep- L–U ratio. This may be the result of biomechanical coupling
ening in the excessively flat upper cornea area may better from local collagen changes around the Intacs segment. Fur-
address keratoconus asymmetry than global flattening ther investigation of the etiology should be considered.
that results from double Intacs placement. Use of asymmet-
ric Intacs and single segments has been reported in other REFERENCES
studies.8–10,14,15
In the current study, C3-R augmented the reversal 1. Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-A-induced colla-
gen crosslinking for the treatment of keratoconus. Am J Ophthalmol
effect of Intacs on the keratoconus cone as shown by the 2003; 135:620–627
greater changes in cylinder, K steep, K average, and L–U 2. Wollensak G, Spoerl E, Seiler T. Stress-strain measurements of human
ratio in the Intacs with C3-R group (Figure 4). Although and porcine corneas after riboflavin-ultraviolet-A-induced cross-link-
we did not use a survey in this study, patients anecdotally ing. J Cataract Refract Surg 2003; 29:1780–1785
3. Spoerl E, Wollensak G, Seiler T. Increased resistance of crosslinked cor-
reported better quality of vision (enhanced contrast, re-
nea against enzymatic digestion. Curr Eye Res 2004; 29:35–40
duced streaking around lights at night) with the combined 4. Wollensak G, Wilsch M, Spoerl E, Seiler T. Collagen fiber diameter in the
treatment. The greater keratometry and L–U reduction rabbit cornea after collagen crosslinking by riboflavin/UVA. Cornea
support these anecdotes. 2004; 23:503–507
The mechanism to account for the greater changes in 5. Spoerl E, Wollensak G, Dittert D-D, Seiler T. Thermomechanical behav-
the Intacs with C3-R group than in the Intacs-only group iour of collagen-cross-linked porcine cornea. Ophthalmologica 2004;
218:136–140
may be a simple additive effect of the procedures as Wollen- 6. Kohlhaas M, Spoerl E, Speck A, et al. Eine neue Behandlung der Kera-
sak et al. 1 observed that collagen cross-linking alone led to tektasie nach LASIK durch Kollagenvernetzung mit Riboflavin/UVA-
an average reduction in keratometry readings of 2.00 D Licht. Klin Monatsbl Augenheilkd 2005; 222:430–436
in human eyes. Another explanation is that the Intacs seg- 7. Sharma M, Boxer Wachler BS. Comparison of single-segment and
double-segment Intacs for keratoconus and post-LASIK ectasia. Am
ment may lead to greater local rigidity from C3-R. It has
J Ophthalmol 2006; 141:891–895
been shown that the collagen changes induced in the cor- 8. Boxer Wachler BS, Christie JP, Chandra NS, et al. Intacs for keratoconus.
nea increase overall biomechanical rigidity by 4.5 times,2 Ophthalmology 2003; 110:1031–1040; errata, 1175
and the placement of an Intacs segment may alter the pat- 9. Hellstedt T, Mäkelä J, Uusitalo R, et al. Treating keratoconus with Intacs
tern and distribution of collagen changes. This in turn corneal ring segments. J Refract Surg 2005; 21:236–246
may lead to increased rigidity locally or across the Intacs 10. Alió JL, Artola A, Hassanein A, et al. One or 2 Intacs segments for
the correction of keratoconus. J Cataract Refract Surg 2005; 31:
segment, producing further flattening. After C3-R without 943–953
Intacs placement, we observed that flattening appears to 11. Kenney MC, Brown DJ, Rajeev B. The elusive causes of keratoconus:
occur largely over the cone itself (Figures 5 and 6). a working hypothesis; the Everett Kinsey Lecture. CLAO J 2000; 26:
Wollensak et al.2,5 explained this targeted effect by dem- 10–13
onstrating that maximum collagen cross-linking occurs in 12. Kenney MC, Chwa M, Atilano SR, et al. Increased levels of catalase and
cathepsin V/L2 but decreased TIMP-1 in keratoconus corneas: evi-
the anterior stroma, which is the area of weakness in kera- dence that oxidative stress plays a role in this disorder. Invest Ophthal-
toconic eyes. During C3-R treatment, we observed that the mol Vis Sci 2005; 46:823–832
riboflavin solution pooled in the contiguous area above the 13. Atilano SR, Coskun P, Chwa M, et al. Accumulation of mitochondrial
superior edge of the Intacs segment and also appeared to DNA damage in keratoconus corneas. Invest Ophthalmol Vis Sci
2005; 46:1256–1263
penetrate the channel of the Intacs. This may produce an
14. Colin J, Cochener B, Savary G, et al. INTACS inserts for treating kerato-
area of locally increased riboflavin concentration in this conus: one-year results. Ophthalmology 2001; 108:1409–1414
area and hence may increase collagen cross-linking at 15. Colin J, Cochener B, Savary G, Malet F. Correcting keratoconus with
that site. intracorneal rings. J Cataract Refract Surg 2000; 26:1117–1122

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