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Lasik Flap Complications
Lasik Flap Complications
PURPOSE: To compare the incidence of flap complications after creation of laser in situ keratomi-
leusis (LASIK) flaps using a zero-compression microkeratome or a femtosecond laser.
SETTING: John A. Moran Eye Center, Department of Ophthalmology, University of Utah, Salt Lake
City, Utah, USA.
DESIGN: Evidence-based manuscript.
METHODS: The flap complication rate was evaluated during the initial 18 months of experience
using a zero-compression microkeratome (Hansatome) or a femtosecond laser (IntraLase FS60)
for flap creation.
RESULTS: The flap complication rate was 14.2% in the microkeratome group and 15.2% in the fem-
tosecond laser group (P Z .5437). The intraoperative flap complication rate was 5.3% and 2.9%,
respectively (P Z .0111), and the postoperative flap complication rate, 8.9% and 12.3%, respec-
tively (P Z .0201). The most common intraoperative complication in the microkeratome group was
major epithelial defect/sloughing; the rate (2.6%) was statistically significantly higher than in the
femtosecond laser group (P Z .0006). The most common postoperative complication in both
groups was diffuse lamellar keratitis (DLK) (6.0%, microkeratome; 10.6%, femtosecond laser)
(P Z .0002).
CONCLUSION: Although the total complication rates between the 2 groups were similar, the micro-
keratome group had significantly more epithelial defects intraoperatively and the femtosecond laser
group had significantly more DLK cases postoperatively.
Financial Disclosure: No author has a financial or proprietary interest in any material or method
mentioned.
J Cataract Refract Surg 2010; 36:1925–1933 Q 2010 ASCRS and ESCRS
A critical step in laser in situ keratomileusis (LASIK) is These include better predictability of postoperative re-
creation of the corneal flap. The 2 most common ways fraction, better uncorrected distance visual acuity
to create the flap are with a femtosecond laser or a me- (UDVA),8 and possible reduction in overall induced
chanical microkeratome. In recent years, the femtosec- astigmatism.3,8,9
ond laser has gained popularity and is replacing Even though femtosecond lasers may offer more ad-
mechanical microkeratomes for LASIK flap creation.1 vantages than mechanical microkeratomes, complica-
The mechanical microkeratome uses shear force trav- tions have been reported after laser flap creation.
eling across the corneal stroma with an oscillating Several studies2,10,11 found the incidence of diffuse la-
blade to create a flap. The femtosecond laser emits mellar keratitis (DLK) to be higher in eyes in which the
a 1053 nm wavelength (infrared) light that produces LASIK flap was created with a femtosecond laser than
microcavitation bubbles at a preset depth in the in those in which the flap was created with a mechan-
corneal stroma.2,3 Because of its precision and more ical microkeratome. Gas breakthrough,12 an opaque
predictable flap depth,3–7 this technology may offer bubble layer,10 transient light-sensitivity syndrome
several advantages over mechanical microkeratomes. (TLSS),13 and suction loss leading to incomplete
flap14 have also been reported with femtosecond of 110 mm, a superior hinge angle of 50 degrees, and a side-
lasers. cut angle of 70 degrees. Patients were instructed to keep their
eyes closed for 5 to 15 minutes after flap creation to ensure
In this study, we analyzed our initial surgical expe-
resolution of the opaque bubble layer. Stromal ablation
rience using a zero-compression microkeratome and was then performed using the Visx Star excimer laser.
a femtosecond laser. We compared the incidence of
intraoperative and postoperative complications using
these 2 methods of LASIK flap creation. Postoperative Treatment
At the completion of the LASIK procedures, gatifloxacin
0.3% was used 4 times a day for 7 days. In the microkeratome
PATIENTS AND METHODS group, prednisolone acetate 1.0% was given 4 times a day for
All patients who had LASIK flap creation with a Hansatome 6 days. In the femtosecond laser group, prednisolone acetate
zero-compression microkeratome (Bausch & Lomb) between 1.0% was given every hour on the day of surgery and then
February 2001 and July 2002 or with an IntraLase FS60 laser 4 times a day for 6 days. The prednisolone acetate 1.0%
(Abbott Medical Optics, Inc.) between August 2006 and dose in the femtosecond laser group was higher because of
January 2008 were included in this retrospective study. The the known increased risk for DLK with this method.
LASIK procedures were performed by 1 of 2 surgeons
(M.M., M.D.M.) at John A. Moran Eye Center. An institu-
tional review board at the University of Utah approved the Postoperative Follow-up
study. All patients were examined at the slitlamp immediately
Patients were screened for surgery with at least 1 cyclople- after surgery and 1 day postoperatively. The frequency of
gic evaluation and 2 manifest refraction evaluations; in all subsequent visits was determined by the nature of the flap
cases, LASIK was deemed safe according to the U.S. Food complication and any treatment required. At a minimum,
and Drug Administration guidelines.A The patients had patients had follow-up visits at 1 week and 1, 3, and 6
a full ophthalmic examination including slitlamp micros- months. The final corrected distance visual acuity (CDVA)
copy, dilated fundoscopy, ultrasound pachymetry, and at 6 months was compared between the microkeratome
topography. group and the femtosecond laser group.
Surgical Technique
Definitions of Complications
Microkeratome Flap Creation The microkeratome used for
LASIK flap creation had a 160 mm zero-compression head Definitions for intraoperative flap complications included
and an 8.5 to 9.0 mm ring. All flaps had a superior hinge. Im- the following:
mediately after flap creation, stromal ablation was started 1. Major epithelial defect/sloughing. A break or a loose area of
using the Visx Star excimer laser (Abbott Medical Optics, epithelium larger than 2.0 mm 2.0 mm.
Inc.). 2. Incomplete flap suction. Suction is lost during passage of the
mechanical microkeratome or during the lamellar cut or
Laser Flap Creation The femtosecond laser procedures side cut using the femtosecond laser.
were performed at 60 kHz in a raster pattern with a bed en- 3. Buttonhole. Inability of the microkeratome or femtosecond
ergy of 1.15 mJ, pulse separation of 8 8, and side-cut energy laser to complete the lamellar cut, resulting in a hole or
of 2.00 mJ, with the pocket enabled. The flaps were created thinning of the flap upon lifting. Because vertical gas
with a diameter between 8.7 mm and 9.0 mm, a thickness breakthrough with the femtosecond laser has a similar
outcome, the complication was included in the buttonhole
group.
4. Torn flap. Any tear in the flap occurring before or during
Submitted: November 3, 2009.
the lifting process.
Final revision submitted: April 7, 2010. 5. Severely decentered flap. A 6.0 mm stromal ablation zone is
Accepted: May 13, 2010. not attainable under the flap.
6. Gas bubbles. Bubbles of gas that accumulate and seep into
From the Department of Ophthalmology and Visual Sciences
the anterior chamber of the eye during femtosecond laser
(Moshirfar, Chang, Mifflin), John A. Moran Eye Center, and the flap creation.
School of Medicine (Schliesser), University of Utah, Salt Lake
City, Utah; Arizona College of Osteopathic Medicine (Gardiner), Definitions for postoperative flap complications included
Glendale, Arizona; Ophthalmology Department (Espandar), Tulane the following:
Health Science Center, New Orleans, Louisiana; Department of 1. Dislocated flap. The flap is displaced from its original
Ophthalmology (Feiz), School of Medicine, University of California position after LASIK.
Davis, Sacramento, California, USA. 2. Epithelial ingrowth. The presence of epithelial cells under
the flap.
Supported in part by an unrestricted educational grant from Aller- 3. Diffuse lamellar keratitis. Sterile inflammation with an
gan, Inc., Irvine, California, to the Department of Ophthalmology accumulation of inflammatory cells in the flap interface.
and Visual Sciences, John A. Moran Eye Center, University of Utah. 5. Central toxic keratopathy. Central stromal opacification
occurring within 1 week of surgery.
Corresponding author: Majid Moshirfar, MD, John A. Moran Eye 6. Transient light-sensitivity syndrome. Light sensitivity out of
Center, 65 Mario Capecchi Drive, Salt Lake City, Utah 84132, proportion to that in normal eyes that typically occurs 2 to
USA. E-mail: majid.moshirfar@hsc.utah.edu. 6 weeks after uneventful LASIK.
Microkeratome
Male:female ratio 0.7:10 1.2:10
Age (y)
Mean G SD 39.42 G 10.16 39.93 G 8.59 .7666
Range 21 to 71 24 to 60
MRSE (D)
Mean G SD 3.74 G 2.34 4.31 G 1.96 .2318
Range 11.00 to 7.25 7.63 to 2.00
K value (D)
Mean G SD 44.18 G 1.37 44.19 G 1.02 .9712
Range 40.00 to 48.05 42.00 to 46.31
Femtosecond laser
Male:female ratio 1:1 1:1
Age (y)
Mean G SD 36.42 G 9.72 34.82 G 8.27 .3053
Range 21 to 68 21 to 56
MRSE (D)
Mean G SD 3.57 G 2.10 4.04 G 1.69 .2270
Range 10.25 to 4.62 8.50 to 1.13
K value (D)
Mean G SD 44.07 G 1.50 43.83 G 0.83 .4477
Range 40.06 to 49.15 41.69 to 45.00
Intraoperative
Buttonhole or gas breakthrough 7 (0.8) 4 7 3 (0.3) 1 3
Torn flap 4 (0.4) 3 4 4 (0.4) 4 4
Decentered flap 5 (0.6) 4 5 1 (0.1) 1 1
Gas bubble in AC 3 (0.3) 3 3
Postoperative
Epithelial ingrowth 2 (0.2) 0 2 1 (0.1) 1 1
Central toxic keratopathy 2 (0.2) 0 2 0 d d
Transient light-sensitivity syndrome 0 d d 4 (0.4) 4 4
Table 3. Comparison of preoperative visual characteristics in cases of buttonhole flap and dislocated flap.
Device/Parameter No-Complication Group Buttonhole Group P Value Dislocated Flap Group P Value
Microkeratome
MRSE (D)
Mean G SD 3.74 G 2.34 4.23 G 2.34 .5813 3.79 G 2.66 .9306
Range 11.00 to 7.25 7.63 to 2.00 6.87 to 1.25
K value (D)
Mean G SD 44.18 G 1.37 44.86 G 0.73 .2272 44.42 G 1.18 .4673
Range 40.00 to 48.05 44.00 to 45.88 41.69 to 45.88
Femtosecond laser
MRSE (D)
Mean G SD 3.57 G 2.10 2.75 G 2.10 .5017 3.03 G 2.33 .4445
Range 10.25 to 4.62 4.13 to 1.13 6.00 to 2.00
K value (D)
Mean G SD 44.07 G 1.50 43.54 G 1.67 .5405 44.50 G 1.34 .4249
Range 40.06 to 49.15 41.69 to 44.94 42.69 to 45.88
a short course of topical corticosteroidal agents with the basement membrane.17 Theoretically, this compli-
no loss of CDVA. cation would not occur with a femtosecond laser
because no direct shearing force is applied to the
corneal surface. Our study supports this, with signifi-
DISCUSSION cantly fewer cases of major epithelial defects (0.6%) in
The femtosecond laser is slowly replacing some the femtosecond laser group.
mechanical microkeratome models in use today. A The other intraoperative complication was incom-
survey foundB that in 2008, more than 50% of all plete flap, and the incidence in the 2 groups was
LASIK flaps were created with a femtosecond laser. similar. However, with the femtosecond laser, the sur-
In this retrospective case series, we compared intra- geon has the option of creating a smaller flap within
operative and postoperative complications during our the original area on the same day or creating a flap
initial 18 months of experience with flap creation using with the original parameters within the next few
a Hansatome zero-compression microkeratome and days. In the case of microkeratomes, most surgeons
an IntraLase FS60 femtosecond laser. The total compli- choose to postpone stromal ablation for several weeks
cation rate was 14.2% in the microkeratome group and to several months, as was the case with the incomplete
15.2% in the femtosecond laser group, with no flaps in our microkeratome group.
statistically significant difference between the groups In our study, vertical gas breakthrough was
(P Z .5437). To our knowledge, this is the first pub- grouped with buttonhole because of the similar results
lished study to compare complications between the 2 in eyes with these 2 complications. With a femtosecond
devices. Jacobs and Taravella15 report a total intra- laser, coalescing of microcavitation bubbles in the
operative complication rate of 0.16% with the stroma causes vertical gas breakthrough.18 The gas
Hansatome microkeratome, lower than the 6.38 rate breakthrough can mislead the surgeon into leaving
with the Automated Corneal Shaper (Bausch & a piece of stroma intact when creating the flap. As
Lomb). In a more recent larger study of the 2 devices,16 the flap is lifted, the intact stroma will tear, causing
the intraoperative complication rate was 0.63% and a hole. The buttonholes in the microkeratome group
1.26%, respectively. In our study, the most common were typically central, round, and approximately
intraoperative complication in the microkeratome 3.0 to 4.0 mm in diameter. The subepithelial gas break-
group was major epithelial defect/sloughing (2.6%), through in the femtosecond laser group was often pe-
a rate that was significantly higher than in the femto- ripheral and 1.0 to 2.0 mm in diameter. Although gas
second laser group (P Z .0006). Polk et al.17 found breakthrough is not typically classified as a buttonhole,
a 2.7% incidence of epithelial defects with the same mi- the final results were the same. The occurrence of
crokeratome, which is comparable to the rate in our buttonholes with a femtosecond laser is rare,12 and
study. This complication is likely caused by the pivotal the lower incidence in our femtosecond group could
movement and shearing force of the microkeratome, be because the laser creates a planar flap rather than the
which has a tendency to disrupt the epithelium from meniscus-shaped flap created by microkeratomes.4,9
The incidence of torn flaps was similar in the 2 without an increase in the incidence of DLK. In our
groups. However, all tears in the femtosecond laser experience, even though the femtosecond laser group
group occurred at the flap hinge, as opposed to the had a higher incidence of DLK, the DLK did not prog-
more central flap tears in the microkeratome group. ress to stage III. This could be attributed to differences
When the tear is at the hinge, it avoids the central in increased dosing of prednisolone acetate 1.0% in the
axis and the surgeon has the option of proceeding acute postoperative period in the femtosecond laser
with stromal ablation on the same day. group.
One eye in the femtosecond laser group had a decen- Central toxic keratopathy results in stromal thin-
tered flap. Decentered flaps have been reported as ning and a hyperopic shift in most eyes.25 The 2 cases
a complication with mechanical microkeratomes; of central toxic keratopathy in our study were in the
however, a literature search found no reports of decen- microkeratome group. Although there were cases of
tered flaps with the femtosecond laser. When a flap is central toxic keratopathy in the femtosecond laser
created with a microkeratome, complete separation of group, this condition has been known to occur with
tissue has taken place by the time the flap is made. the laser.25 Central toxic keratopathy has also been
However, with a femtosecond laser, the surgeon can observed with PRK,25 suggesting that it may not be
chose not to disrupt the flap and to create a different appropriate to classify it solely as a flap complication.
flap at a later date. Bubbles in the anterior chamber, TLSS, and rainbow
A significant finding in our study was the greater oc- glare are complications unique to the femtosecond
currence of flap dislocation in the microkeratome laser. The gas bubbles formed by the laser can accumu-
group. The lower incidence of flap dislocations in the late in the flap interface and seep through the trabecu-
femtosecond laser group is likely a result of the laser’s lar meshwork into the anterior chamber of the eye.19
steeper side-cut angle and deeper gutter and the Two case reports by Srinivasan and Rootman26 and
increased adhesion strength of the femtosecond Lifshitz et al.27 found that anterior chamber bubbles
flap.19–21 can interfere with pupil tracking but are self-limiting
The incidence of DLK was significantly higher in the and resolve over a short period. Our experience agrees
femtosecond laser group than in the microkeratome with these reports; all cases of anterior chamber bub-
group (P Z .0002). Diffuse lamellar keratitis is charac- bles in our series resolved and were successfully
terized by diffuse white granular lamellar keratitis.22 It treated without significant delay. Unlike anterior
has been hypothesized that an accumulation of gas chamber bubbles, TLSS and rainbow glare occur
bubbles and femtosecond laser energy could increase postoperatively. Their exact cause is not known. It is
the inflammatory response in patiens who might be theorized that in TLSS, the increased energy from the
more susceptible to DLK.2 Earlier models of the laser femtosecond laser stimulates local keratocytes, corneal
we used, especially the 15 kHz and earlier models, nerve endings, or both.13 Stonecipher et al.13 evaluated
not only used higher energy levels but also had a pulse different groups with a TLSS incidence rate of 1.0% to
geometry that produced a larger width cut through the 1.4%; they noted that when the raster and side-cut en-
epithelium around the perimeter of the flap. This cre- ergy settings were lowered (by an average of 24% and
ated a flap edge that was easier for the surgeon to 33%, respectively), there was a significant reduction in
visualize at the operating microscope but that resulted the incidence of TLSS. Our raster and side-cut energy
in more epithelial damage, a greater release of settings were well below the lowest settings that Stone-
epithelial-derived cytokines, greater production of cipher et al.13 recommend; as a result, we had a lower
keratocyte-derived chemokines, and more inflamma- incidence of TLSS. Similar to TLSS, rainbow glare
tory cell infiltration.23,24 One explanation for the high- appears to occur more often with higher raster energy
er incidence of DLK in our study might be the use of settings.28 Although there were no cases of rainbow
2 mJ energy for the side cut because higher energies, glare in our study, it is important to recognize this com-
even in the side cut, produce more cell damage, plication and its relationship to the femtosecond laser.
a greater release of cytokines, and more inflammatory There are several limitations to our study. First, we
cell infiltration. A study by de Medeiros et al.23 com- compared only 1 one type of microkeratome and 1
pared the wound-healing response in rabbit corneas type of femtosecond laser. Thus, our results may not
using different energy ranges. At the low end of be applicable to all types of microkeratomes or femto-
the femtosecond laser energy range (from 0.7 mJ to second lasers. In addition, this was a retrospective
1.6 mJ), cell death and inflammatory cell infiltration analysis. A prospective study could have addressed
were small. The authors mentioned that in their prac- the question better; however, we wanted to evaluate
tice, with refinement in energy selection, postoperative the first patients to be treated with these 2 methods
corticosteroid treatment had become identical to what because theoretically, there would be more complica-
they use in LASIK performed with a microkeratome, tions early in the use of these methods. This
comparison would not be possible in a prospective 7. Patel SV, Maguire LJ, McLaren JW, Hodge DO, Bourne WM.
study because we are no longer using the microkera- Femtosecond laser versus mechanical microkeratome for LASIK;
a randomized controlled study. Ophthalmology 2007; 114:1482–
tome for LASIK flap creation at our institution. 1490. Available at: http://download.journals.elsevierhealth.com/
Another limitation is the different postoperative pred- pdfs/journals/0161-6420/PIIS0161642006015880.pdf. Accessed
nisolone acetate 1.0% dosing in the microkeratome July 9, 2010
group and the femtosecond laser group. Because this 8. Durrie DS, Kezirian GM. Femtosecond laser versus mechanical
was a retrospective study, we could not control for keratome flaps in wavefront-guided laser in situ keratomileusis:
prospective contralateral eye study. J Cataract Refract Surg
this limitation. Although the study evaluated a signifi- 2005; 31:120–126
cant number of eyes (nearly 1800), flap complications 9. Stonecipher K, Ignacio TS, Stonecipher M. Advances in
are uncommon; therefore, a larger number of patients refractive surgery: microkeratome and femtosecond laser
would have added more statistical power to the study. flap creation in relation to safety, efficacy, predictability,
This study also did not assess the rate of enhancement, and biomechanical stability. Curr Opin Ophthalmol 2006;
17:368–372
dry eye, or long-term complications, all of which are 10. Chang JSM. Complications of sub-Bowman’s keratomileusis
important parameters when evaluating the pros and with a femtosecond laser in 3009 eyes. J Refract Surg 2008;
cons of LASIK flap creation. 24:S97–S101
We did not find a significant difference in the total 11. Javaloy J, Vidal MT, Abdelrahman AM, Artola A, Alió JL. Confo-
complication rate between the microkeratome group cal microscopy comparison of IntraLase femtosecond laser and
Moria M2 microkeratome in LASIK. J Refract Surg 2007;
and the femtosecond laser group. The final CDVA in 23:178–187
complicated cases appeared to be clinically better in 12. Srinivasan S, Herzig S. Sub-epithelial gas breakthrough during
the femtosecond laser group; however, the difference femtosecond laser flap creation for LASIK [video report]. Br J
between groups was not statistically significant. The Ophthalmol 2007; 91:1373
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light sensitivity after femtosecond laser flap creation: clinical
number of intraoperative complications than the fem- findings and management. J Cataract Refract Surg 2006;
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group had a statistically greater number of postopera- tosecond laser pass for incomplete laser in situ keratomileusis
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