Surgery for Esotropia Under Topical

Anesthesia
Jaime Tejedor, MD, PhD,1,2 Consuelo Ogallar, MD,1 Jos M. Rodrguez, MD1
Purpose: To compare a surgically adjusted dose of strabismus surgery using topical anesthesia in cooperative
patients with dosage guidelines adapted to the surgeons personal technique using sub-Tenons anesthesia.
Design: Randomized, controlled, single-site clinical trial.
Participants: Sixty patients with nonparalytic, nonrestrictive esotropia who were cooperative for surgery
under topical anesthesia.
Methods: Twenty-eight patients were assigned to topical anesthesia, and 32 patients were assigned to
sub-Tenons anesthesia. Visual acuity, refraction, and deviation angle were determined in all patients preoperatively and postoperatively, and stereoacuity was measured postoperatively. Deviation angle was measured by
simultaneous and alternate prism and cover test, and stereoacuity was measured using Randot circles (Stereo
Optical Co., Chicago, IL). The amount of surgery under topical anesthesia was adjusted intraoperatively.
Main Outcome Measures: The amount of surgery used in the 2 treatment groups (measured in millimeters
and millimeter/degree of deviation angle) and 6-month motor and stereoacuity outcomes.
Results: Patients in the topical group required 3.2 mm less surgery on average than those in the subTenons group (5.9 and 9.1 mm, respectively; 0.4 and 0.6 mm of recession/degree, respectively) (P 0.01).
Motor success (84% and 75%, respectively, P0.38) and stereoacuity (339.6 and 323.9 arc seconds, respectively, P0.87) at 6 months were similar in the 2 groups.
Conclusions: Topical anesthesia requires a smaller amount of surgery and number of operated muscles to
correct esotropia compared with classic surgery guidelines adapted to the surgeons personal technique.
Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed
in this article. Ophthalmology 2010;117:18831888 2010 by the American Academy of Ophthalmology.

Different types of anesthesia have been used in surgery for

strabismus. Topical anesthesia avoids the risk of needle
insertion, occurring in retrobulbar or peribulbar block (including retrobulbar hemorrhage, globe perforation, postoperative diplopia, bradycardia, and optic nerve lesion or
central effects), and the uncommon side effects of general
anesthesia. Nevertheless, topical anesthesia may be associated with surgeon discomfort and, as in other local procedures, pain and stress for the patient, oculocardiac reflex,
and frequent need for intravenous sedatives. Sub-Tenons
anesthesia is more comfortable for the patient and surgeon
than topical anesthesia, but it does not enable intraoperative
adjustment of alignment as the latter does, and sometimes
decreased effectiveness or release of the anesthetic agent
may occur. Topical anesthesia is used in cooperative adult
patients.117 This technique is feasible and well tolerated,
especially when scarring from previous interventions is not
present. Outcomes of strabismus surgery with topical anesthesia may be as satisfactory as those with general anesthesia or sub-Tenons injection.3,9,15,17 We have been using a
gradual approach in topical anesthesia, with successive
measurements of alignment to choose the number of operated muscles and avoid large recessions. This strategy enables a smaller amount of surgery than guidelines reported
by most strabismus surgeons in general or with sub-Tenons
anesthesia. When compared with published theoretic classic
table guidelines, the amount of surgery required using topical
2010 by the American Academy of Ophthalmology
Published by Elsevier Inc.

anesthesia in patients with esotropia was smaller (Invest Ophthalmol Vis Sci 2009;50[Suppl];1137). The present study compares, in a clinical trial, the total amount of surgery used under
topical and sub-Tenons anesthesia, considered as a surrogate
primary outcome, and the motor and sensory outcomes obtained using the 2 different procedures.

Patients and Methods

The institutional ethics committee approved the present study,
which adhered to the tenets of the Declaration of Helsinki. Informed consent was obtained from all patients, or their parents
when appropriate, before inclusion. This trial was registered under
ClinicalTrials.gov number NCT00993174.

Patient Eligibility
Criteria for eligibility were as follows: age 15 to 60 years with an
esotropia deviation angle 45 prism diopters (D) (requiring 1- or
2-muscle surgery), visual acuity at least 20/40 in each eye, and
cooperation for topical anesthesia. Criteria for cooperation included the ability to tolerate manipulation of the bulbar conjunctiva with a cotton swab, a facility with topical drops, and the ability
to undergo applanation tonometry or forced duction testing. Subjects with paralytic or restrictive strabismus, previous muscle
surgery, high myopia (6 D), and significant eye disease other
than strabismus (retinal disease, glaucoma, media opacities) were
excluded.
ISSN 0161-6420/10/$see front matter
doi:10.1016/j.ophtha.2010.02.012

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Ophthalmology Volume 117, Number 10, October 2010

Examination Procedures
Visual acuity (Early Treatment Diabetic Retinopathy Study chart),
refraction, eye deviation, tonometry, anterior segment biomicroscopy, and funduscopy were carried out at enrollment and 3 and 6
months after surgery. Eye deviation was measured by the simultaneous and alternate prism and cover test, with glasses when
necessary. Binocularity (Randot circles, Stereo Optical Co., Chicago, IL) was assessed only at 6 months. In these clinical examinations, investigators were masked to the treatment group.

Surgical Technique
Surgery was always performed by the same surgeon (JT). Oxybuprocaine/tetracaine drops were used before surgery, plus 2% lidocaine gel during surgery. After a small fornix conjunctival and
Tenons capsule incision, lidocaine gel was applied over the muscle operated area and gradually removed by surgical maneuvers,
surgical spears cleaning, and balanced salt solution irrigation.
A recession (non-fixed hang-back) using Dexon II 6/0 suture
(Covidien Syneture, Norwalk, CT) was made initially, after which
near and distance alignment were measured intraoperatively. Patients were made to sit up for measurements, obtained using the
simultaneous and alternate prism and cover test with an accommodative fine-detail fixation target. In the intraoperative examination, our aim was to obtain a distance esodeviation 5 prism D.
This criterion was based on our preceding experience indicating
that the total effect of muscle surgery is not observed immediately
(Invest Ophthalmol Vis Sci 2009;50[Suppl];1137). Recessions of
medial rectus, starting with half the muscle dose estimated necessary for that deviation in our personal dosage guidelines (Table 1),
could be augmented in steps of 1.5 to 2 mm to a maximum of 6.5
mm to avoid postoperative limitation of muscle function (larger
recessions were not likely to be necessary for deviations up to 45
prism D). If an esodeviation 5 prism D at distance was not
achieved using single-muscle surgery, a contralateral recession
was performed and deviation was remeasured. Glasses worn by
patients were sterilized using ethylene oxide or immersed in
PeraSafe solution (FHP, Madrid, Spain) for 10 minutes before
surgery. Patients in the sub-Tenons anesthesia group underwent
operation with the same surgical technique as in the topical anesthesia group, using a flattened-tip cannula (BD Visitec, Franklin
Lakes, NJ) for 2% lidocaine injection through the Tenons capsule
opening and applying a dosage according to classic guidelines,
modified according to the surgeons personal technique (Table 1).
An adjustable suture was left in place in 1 operated muscle in the
2 study groups. Adjustments were made on postoperative day 1
(noose technique) without masking of the surgeon to the procedure
type. Indications for adjustment were diplopia, cosmetic appearance, and particularly any exodeviation and an esodeviation of 8
Table 1. Personal Dosage Guidelines Used in the Sub-Tenons
Anesthesia Group
Deviation Angle ()

Total MRM Recession (mm)

15.00
20.00
25.00
30.00
35.00
40.00
45.00

6.50
7.50
8.50
9.50
10.50
11.50
12.50

MRM medial rectus(i) muscle(s); prism diopters.

1884

prism D at distance. All patients were followed for 6 months after

surgery to determine motor outcome as measured by the simultaneous and alternate prism and cover test, and stereopsis by the
Titmus fly and Randot circles stereoacuity test.

Statistical Techniques and Estimation of

Sample Size
Participating patients were from our clinic population of consecutive cases. Group sample sizes of 22 achieved 91% power to
detect a difference of 2.0 mm between the 2 groups, with known
standard deviations of 2.0 and a significance level (alpha) of 0.05
using a 2-sided, 2-sample t test. The trial was designed to recruit
a total of 60 patients for randomization. Patients were randomized
to surgery using topical or sub-Tenons anesthesia. Randomization
was done through a central office using a computer-generated
random number list for treatment allocation. Comparisons of continuous variables were performed using the unpaired Student t test
or nonparametric procedures (MannWhitney test). Analysis of
variance/covariance was used to correct for other variables. Percentage comparisons were performed using the chi-square test.
The Statistical Package for the Social Sciences (SPSS Inc., Chicago, IL) was always used to compute statistical analyses. The
significance level cutoff was fixed at the standard level of 0.05.
Data were analyzed according to the group to which patients were
originally assigned. The primary outcome was the amount of
surgery used in the 2 treatment groups, measured in millimeters
and millimeters/degree of deviation angle. The secondary outcome
was the 6-month motor result as measured by the simultaneous
prism and cover test at distance (prism diopters converted to
degrees for comparisons), and stereoacuity as measured by Randot
circles (log seconds of arc were used for comparisons). Other
variables measured were the number of muscles operated (1 or 2),
duration of the surgical procedure, and requirement of adjustment
on postoperative day 1.

Results
Of 91 patients examined for inclusion, 31 were excluded because
of previous surgery (8), a restrictive condition (7), paralytic strabismus (6), poor visual acuity (4), or an estimated lack of cooperation (6). Of 60 patients who entered the trial, 32 were assigned
to sub-Tenons anesthesia and 28 were assigned to topical anesthesia. The characteristics of the patients included are shown in
Table 2. Differences in age (P0.81), gender (P0.55), diagnosis
distribution (P0.9), visual acuity in the worse eye (P0.86), and
deviation angle (P0.33) between the 2 groups were not detected.
One patient in the topical group had to undergo operation using
sub-Tenons anesthesia because of poor cooperation, but this patient was included in the analysis of the topical group according to
the intention-to-treat principle. This patient did not require postoperative adjustment.

Amount of Surgery
The primary outcome was obtained in 28 patients in the topical
group (100%) and 30 patients in the sub-Tenons group (93%) (2
patients finally refused to undergo surgery). The average amount
of surgery required in the topical group was 5.9 mm (95% confidence interval [CI], 5.5 6.3), and the average amount of surgery
used in the sub-Tenons group was 9.1 mm (95% CI, 8.59.8), that
is, a difference of 3.2 mm was observed between the 2 treatment
groups (95% CI, 2.4 4; P 0.01). This difference remained
significant after correcting for age, gender, preoperative deviation,

Tejedor et al Topical Anesthesia for Esotropia Surgery

Table 2. Patient Characteristics

Deviation angle* (degrees,

prism D)
Visual acuity in the worse
eye* (logMAR
units, Snellen)
Refraction* (D)
Age* (yrs)
Gender (male/total)
Type of deviation (n)
Recurrent childhood
esodeviation
Acute comitant
esotropia
Sensory deviation
Age-induced esotropia
Type of postoperative
adjustment (n)
Advancement
1 mm
2 mm
3 mm
Recession
1 mm
2 mm
3 mm

Topical Anesthesia

Sub-Tenons
Anesthesia

14.94 (13.4816.41)
26.82 (24.0629.57)
0.05 (0.08 0.02)
0.89 (0.82 0.95)

16.04 (14.3217.76)
28.96 (25.6832.25)
0.04 (0.07 0.02)
0.9 (0.84 0.95)

0.42 (0.321.16)
38.14 (34.5141.77)
17/28

0.98 (0.11.87)
37.53 (33.5741.48)
17/32

12

16

7
2

7
3

1
1

1
1
1

2
1

1
1
3

89% of the sub-Tenons group outcome examinations. The motor

success rate at 6 months was similar in the 2 treatment groups22
of the 26 patients who completed the examination of the topical
group (84%) and 21 of the 28 patients in the sub-Tenons anesthesia group (75%) had a successful motor outcome (P0.38). A
small exodeviation ( 8 ) was found in 3 patients in the topical
group (11%) and in 2 patients in the sub-Tenons group (7%). All
of the 4 patients with an unsuccessful motor outcome in the topical
group had residual esotropia: 10 , 14 , and 12 in 2 cases. In
the sub-Tenons group, of the 7 patients with unsuccessful motor
outcome, 4 had 10 and 3 had 12 of residual esotropia. Average
deviation was similar in the 2 groups at 6 months (4.3 , 95% CI,
2.20 6.41; 4.14 , 95% CI, 2.26 6.01, P0.9, after conversion
to degrees). Figure 3 summarizes the cumulative frequency of
deviation at 6 months in the 2 treatment groups. Stereoacuity also
was similar in the 2 groups (339.6 arc seconds, 95% CI, 220.8
458.3 in the topical group; 323.9 arc seconds, 95% CI, 167.9
479.9 in the sub-Tenons group; P0.87, after conversion to log
arc seconds).

CI confidence interval; D diopters; logMAR logarithm of the

minimum angle of resolution.
*Mean (95% CI).

visual acuity in the worse eye, and diagnosis (P 0.01, Fig 1).
After incorporating the magnitude of postoperative adjustments
(Table 2) with the amount of surgery, the average result was 6 mm
(95% CI, 5.2 6.7) in the topical group and 9.3 mm (95% CI,
8.310.3) in the sub-Tenons group (P 0.01). In the topical
anesthesia group, an average of 0.4 mm of recession/degree of
deviation angle was necessary. In the sub-Tenons group, an
average of 0.6 mm of recession/degree of deviation was necessary.
A difference of 0.2 mm/degree was found between the 2 groups
(95% CI, 0.15 0.23; P 0.01), which remained significant after
correction for the referred potential confounding variables
(P 0.01). Figure 2 depicts the amount of surgery used versus
deviation angle in the 2 groups.
On postoperative day 1, adjustments were necessary in 5 patients (18%) in the topical anesthesia group and in 8 patients
(26.7%) in the sub-Tenons anesthesia group, but frequency of
adjustment was considered similar in the 2 groups (P0.42).
Two-muscle surgery was necessary in 7 patients in the topical
group (25%) and in 26 patients in the sub-Tenons group (87.6%),
which was significant (P 0.01). However, the mean duration of
the surgical procedure was not different in the 2 groups (38.4
minutes in the topical group and 45.2 minutes in the sub-Tenons
group, P0.38), which indicates that surgical time per muscle was
longer in the topical group.

Motor and Sensory Outcomes

The 6-month secondary outcome examination and the 3-month
visit were completed by 26 patients in the topical group (92%) and
by 28 patients in the sub-Tenons group (87%). The examiner was
masked to the treatment group in 84% of the topical group and

Figure 1. Comparison of mean surgery (95% CI) used in patients in the

topical and sub-Tenons anesthesia groups, disregarding postoperative adjustment (A) and incorporating postoperative adjustment (B). Anes
anesthesia; CI confidence interval; Subten sub-Tenons.

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classic table guidelines, adapted to the surgeons personal
technique, particularly using sub-Tenons anesthesia. On
average, approximately 3 mm less of medial rectus recession was required in the topical anesthesia group compared
with the sub-Tenons anesthesia group. Although some
variability may be observed in the amount of surgery used
for a particular deviation in the topical group (Fig 2), it is
clearly less than that in the sub-Tenons group. The amount
of surgery is a surrogate primary outcome selected because
the reason to conduct this study was to test the hypothesis,
based on clinical impression, that less surgery was needed
when topical anesthesia was used versus other anesthetic
methods with a preestablished surgical dosage. Performing
less surgery may be beneficial because complications are
less frequent when treatment is less aggressive, for example,
avoids approaching an area of the lengthtension curve
where small changes in medial rectus recession may have
unpredictable consequences in correcting the deviation,
avoids inducing limitations in the field of action of a largely
recessed muscle with subsequent incomitant deviation in
that position of gaze, and sometimes leaves a muscle untouched for the possibility of future surgery.
A plausible explanation for the smaller amount of surgery required under topical anesthesia is that a reduction of
rotational force of the recessed muscle, according to the
lengthtension curve, may be followed by immediate contracture of the ipsilateral antagonist. Fast changes in deviation observed after muscle recession intraoperatively contribute to sustain this argument. This sequence of events
would not occur when muscle contraction is prevented by
the anesthetic drug, whereas in the topical group fusional
vergences are more intact. When the recessed muscle loses
the arc of contact with the globe (6 mm in the medial rectus
muscle),18 there is a further decreasing percent change in
the original torque acting on the globe. Taking into account
the effect of the muscle pulley (torque vector model), which

Figure 2. Relationship between amount of surgery (millimeter) used and

preoperative deviation angle (degrees) in the 2 groups of patients, disregarding postoperative adjustment (A) and incorporating postoperative
adjustment (B). Anes anesthesia; Subten sub-Tenons.

In the topical anesthesia group, 11 of 28 patients had diplopia

before surgery, and 4 of 26 patients reported diplopia after surgery,
which was correctable with prisms in all cases. In the sub-Tenons
group, 12 of 32 patients had diplopia before undergoing surgery,
and in 3 of 28 patients, diplopia symptoms remained after undergoing surgery. Diplopia was fully correctable using prisms in 2 of
them, but intermittent diplopia was still present in the remaining
patient.

Discussion
Correction of esotropia under topical anesthesia requires a
smaller amount of surgery than commonly used following

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Figure 3. Cumulative percentage of deviation angle (prism diopters) at

the 6-month outcome examination by treatment group. Anes anesthesia; Subten sub-Tenons.

Tejedor et al Topical Anesthesia for Esotropia Surgery

redirects the force on the globe away from the orbital apex,
there is reduction of the original torque even with smaller
recessions, as the torque vector deviates from the tangent of
the globe.19 However, the change in eye position is not
completely achieved immediately after muscle surgery under topical anesthesia. A potential risk of topical anesthesia
is that using the classic amount of surgery (according to
existing tables) or trying to obtain orthotropia intraoperatively might induce overcorrection, at least in patients with
esotropia.
Sharma et al20 found better outcomes after single-stage
adjustable strabismus surgery for exodeviation under topical
anesthesia, compared with conventional recessionresection
surgery. They claim that more prominent central sag of the
muscle belly observed in the former group resulting from
early reinnervation of the muscle may cause an over-recession
effect. An advantage of requiring less surgery, frequently
operating a single muscle, is a decrease in the risk associated with additional muscle surgery, but reduction of time in
a procedure with topical anesthesia in comparison with
sub-Tenons anesthesia is not to be expected according to
our data (time per muscle is longer in the topical procedure).
The dose-response curve approximates an exponential
shape as more millimeters of recession are performed, placing the patient at greater risk of overcorrection, unpredictability of results, or greater effect of small measurement
errors. Posterior muscle slippage, subsequent limitation of
muscles action, and incomitance of eye deviation are also
of concern when large recessions are carried out.
We have used the motor and sensory result as an important secondary outcome. The 6-month motor success for
topical anesthesia in the present study is comparable to the
outcome reported at 6 weeks (79% success rate)3,9 or 6
months (85% success rate),17 and less favorable compared
with previously published data on outcome immediately
after surgery (95%),17 on postoperative day 1 (95%),3,9
and at 3 weeks or 1 month postoperatively (90%).15,17
Notably, on postoperative day 1, 25 of the 28 patients in the
topical group (89.3%) had a manifest deviation less than 8
(2/5 who received adjustment had a small exodeviation),
and 26 of the 30 patients in the other arm of the study
(86.7%) had a manifest deviation less than 8 (3/8 patients
receiving adjustment had a small exodeviation; 1 of them
had a variable deviation of 8 10 and was also adjusted).
These figures are in agreement with those reported on
success rates on postoperative day 1 and at 3 weeks postoperatively. Although similar motor and sensory outcomes
were obtained in the 2 study groups, there is a trend toward
better outcomes in the topical group. To clarify whether
there is any difference in the long-term between the 2
different anesthetic methods requires further study.
A potential criticism for the present study is that the
surgeon may have tried to perform the least amount of
surgery in the topical group, while performing the preestablished amount in the sub-Tenons group. To prevent this
potential source of bias, the topical target angle always had
to be between orthotropia and 5 esotropia. The only
patient in the topical group who had to undergo surgery
under sub-Tenons anesthesia, because of inappropriate cooperation, was maintained in the topical group for analysis,

which would decrease the difference between the 2 treatment groups or tend to assimilate topical to the other anesthetic modality.
By using a qualitative pain intensity rating scale (none,
mild, moderate, severe), pain was considered mild by 14
patients (including the patient shifted to sub-Tenons anesthesia), moderate by 10 patients, and severe by 4 patients in
the topical group; pain was categorized as none by 3 patients, mild by 18 patients, moderate by 7 patients, and
severe by 2 patients in the sub-Tenons group.
In conclusion, the use of topical anesthesia may be
advantageous, especially in patients with esotropia, because
a smaller amount of surgery is usually required in comparison with typical guideline recommendations, and frequently 1-muscle surgery may be enough, reducing the risk
of additional muscle surgery.
Acknowledgment. The authors thank Vctor Abraira, PhD, for
assistance with the statistical analysis.

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Footnotes and Financial Disclosures

Originally received: November 8, 2009.
Final revision: February 3, 2010.
Accepted: February 10, 2010.
Available online: June 8, 2010.

Manuscript no. 2009-1554.

Department of Ophthalmology, Hospital Ramn y Cajal, Madrid,

Spain.
2

Faculty of Medicine, Universidad Autnoma de Madrid, Madrid,

Spain.

1888

Financial Disclosure(s):
The author(s) have no proprietary or commercial interest in any materials
discussed in this article.
Supported by Fundacin de Investigacin Biomdica, Hospital Ramn y
Cajal, Madrid, Spain.
Correspondence:
Jaime Tejedor, MD, PhD, Department of Ophthalmology, Hospital Ramn
y Cajal, C. Colmenar km 9100, Madrid 28034, Spain. E-mail: jtejedor.
hrc@salud.madrid.org.