Post-LASIK Visual Quality With a Corneoscleral Contact Lens to Treat Irregular Corneas

Abstract

Objective:
To evaluate the visual quality results of fitting a corneoscleral contact lens with multiaspheric geometry design (MAGD CScL) in subjects with irregular corneas after laser-assisted in situ keratomileusis (LASIK) surgery.

Methods:
From a database of patients evaluated for scleral contact lenses, we identified those with irregular corneas and visual problems after they underwent LASIK surgery for correcting myopia. They manifested unsatisfactory visual quality with their current contact lenses or glasses. Therefore, a MAGD CScL was fitted and monitored according to standardized fitting methodology. A diagnostic trial set was used in the fitting process. Visual acuity (VA), subjective visual quality (SVQ), and ocular aberrations were evaluated. A new re-evaluation of these parameters was performed after 1 year wearing MAGD CScL.

Results:
Eighteen eyes of 18 patients (10 male and 8 female) with irregular cornea after LASIK surgery participated in this study; their ages ranged from 27 to 39 years (mean±SD, 32.6±3.8 years). All patients showed good fitting characteristics: optimal values were seen for lens position and lens movement. Statistically significant differences were found between before and after fitting MAGD CScL in the VA (mean±SD, 0.14±0.03 logMAR and 0.01±0.06 logMAR, respectively; P<0.001); ocular aberrations of second-order, coma, spherical; and the total higher-order aberrations (HOAs) (all P<0.001). The total HOAs decreased by approximately 78% to normal levels after fitting MAGD CScL. In addition, SVQ was also significantly improved after fitting MAGD CScL (16 eyes were favorable or very favorable). After 1 year wearing MAGD CScL, no statistically significant differences were found in the total HOAs and VA in regard to the initial fitting.

Conclusions:
Corneoscleral contact lens with multiaspheric geometry design is proposed as an effective procedure, providing a good VA and an optimal visual quality on irregular corneas after LASIK surgery in myopic subjects.

Full text

ARTICLE
Post-LASIK Visual Quality With a Corneoscleral Contact Lens
to Treat Irregular Corneas
Esteban Porcar, O.D., Ph.D., Enrique España, M.D., Ph.D., Juan Carlos Montalt, O.D., M.Sc.,
Josefa Isabel Benlloch-Fornés, O.D., M.Sc., and Cristina Peris-Martínez, M.D., Ph.D.
Objective: To evaluate the visual quality results of fitting a corneoscleral
contact lens with multiaspheric geometry design (MAGD CScL) in subjects
with irregular corneas after laser-assisted in situ keratomileusis (LASIK)
surgery.
Methods: From a database of patients evaluated for scleral contact lenses,
we identified those with irregular corneas and visual problems after they
underwent LASIK surgery for correcting myopia. They manifested
unsatisfactory visual quality with their current contact lenses or glasses.
Therefore, a MAGD CScL was fitted and monitored according to
standardized fitting methodology. A diagnostic trial set was used in the
fitting process. Visual acuity (VA), subjective visual quality (SVQ), and
ocular aberrations were evaluated. A new re-evaluation of these parameters
was performed after 1 year wearing MAGD CScL.
Results: Eighteen eyes of 18 patients (10 male and 8 female) with irregular
cornea after LASIK surgery participated in this study; their ages ranged
from 27 to 39 years (mean6SD, 32.663.8 years). All patients showed good
fitting characteristics: optimal values were seen for lens position and lens
movement. Statistically significant differences were found between before
and after fitting MAGD CScL in the VA (mean6SD, 0.1460.03 logMAR
and 0.0160.06 logMAR, respectively; P,0.001); ocular aberrations of
second-order, coma, spherical; and the total higher-order aberrations
(HOAs) (all P,0.001). The total HOAs decreased by approximately 78%
to normal levels after fitting MAGD CScL. In addition, SVQ was also
significantly improved after fitting MAGD CScL (16 eyes were favorable
or very favorable). After 1 year wearing MAGD CScL, no statistically
significant differences were found in the total HOAs and VA in regard to
the initial fitting.
Conclusions: Corneoscleral contact lens with multiaspheric geometry
design is proposed as an effective procedure, providing a good VA and
an optimal visual quality on irregular corneas after LASIK surgery in
myopic subjects.
Key Words: Higher-order aberrations—Corneoscleral contact lens—
Refractive surgery—LASIK—Irregular cornea.
(Eye & Contact Lens 2015;0: 1–5)
Laser-assisted in situ keratomileusis (LASIK) surgery gener-
ally has an excellent safety profile and very high success
rate.
1–3
Most people undergoing LASIK surgery are satisfied with
the rapid improvement of the visual acuity (VA) and therefore do
not need to wear glasses or contact lenses. However, despite recent
advances in refractive surgery procedures, a small percentage of
patients still have problems with their vision.
4–7
A recent study
about LASIK Quality of Life published on the US Food and Drug
Administration website
8
has shown that up to 4% of subjects were
dissatisfied with their vision 3 months after LASIK surgery. In
addition, this also caused a lot of difficulty with or even an inability
to do normal activities in up to 1.0% of subjects not wearing
correction.
Eye symptoms in some post-LASIK eyes include halos, starbursts,
double vision, multiple images, and smeared vision. These symp-
toms are mainly related to corneal surface irregularities after LASIK
surgery. This may be due to flap complications or laser correction
(not properly centered on the eye or from irregular ablation) that may
originate abnormal levels of higher-order aberrations (HOAs).
4,6,9,10
In a study by McCormick et al.,
6
33 symptomatic post-LASIK eyes
with irregular corneas experienced HOAs (mean6SD, 1.3860.58
mm) that were 2.3 to 3.5 times greater than those in an asymptomatic
post-LASIK group and a normal preoperative eyes group
(mean6SD, 0.5860.21 mm and 0.3860.14 mm, respectively, over
a 6-mm pupil size and mean age of 44).
Higher-order aberrations are measured with a wavefront aberr-
ometer, providing quite useful information on the optical quality of
the eye. This assesses the shape and severity of the deviated light
rays when they pass through the optical system of the eye on the
way to the retina. A wavefront error (WFE) is defined as the
deviation of the wavefront in the optic system of the eye in respect
to an ideal wavefront plane.
Higher-order aberrations are not compensated by traditional
spherocylindrical spectacles.
11
However, contact lenses provide an
effective option to the compensation of residual ametropia and
HOAs, masking surface corneal irregularities with the tear lens
between the posterior lens surface and anterior corneal surface.
10
Therefore, fitting rigid gas-permeable (RGP) contact lens or scleral
contact lens (ScL) seems to be more effective than soft contact lens
for irregular corneas.
4,12–14
Scleral contact lens fitted after LASIK
surgery is an adequate option to prescribe, especially when other
contact lenses (including piggyback, hybrid, or RGP lenses) do not
provide adequate VA or are not well tolerated (excessive move-
ment and/or decentration).
15
A few studies
16–20
have included some cases about fitting ScL on
irregular corneas after LASIK surgery. The results of their visual
From the Department of Optics (E.P., J.C.M, J.I.B-F.), Optometry and
Vision Science, Physics College, University of Valencia, Burjassot, Valencia,
Spain; Department of Surgery (E.E.), Ophthalmology Unit, La Fe University
and Polytechnic Hospital, Faculty of Medicine and Odontology, University
of Valencia, Valencia, Spain; and FISABIO Oftalmología Médica (FOM) (C.
P-M.), Cornea Unit and Anterior Segment Diseases, Catholic University of
Valencia, Valencia, Spain.
The authors have no funding or conflicts of interest to disclose.
Address correspondence to Esteban Porcar, O.D., Ph.D., Faculty of
Physics, Department of Optics, Optometry and Vision Science, Dr. Moliner
50, Burjassot 46100, Valencia, Spain; e-mail: esteban.porcar@uv.es
Accepted November 2, 2015.
DOI: 10.1097/ICL.0000000000000231
Eye & Contact Lens !Volume 0, Number 0, Month 2015 1
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quality were measured in terms of improvement in VA; however,
HOAs were not commonly analyzed. Gemoules and Morris
17
as-
sessed the effects of a corneo-ScL with reverse geometry design on
the WFEs of 20 eyes with irregular postsurgical corneas. They
found a mean 66% reduction in the total HOAs. However, the
aberrations were measured for the full pupil diameter of each
eye: this ranged between 5.0 and 7.3 mm, so that the results from
different eyes were not strictly comparable. In addition, it should
be noted that differences in the HOAs can result from the manu-
facture methods of the lens according to their geometric design.
21
This study describes our experience of fitting a corneoscleral
contact lens with multiaspheric geometry design (MAGD CScL)
on irregular corneas after LASIK surgery in terms of visual quality.
METHODS AND MATERIALS
Patient Population
From a database of patients evaluated for CScL at FISABIO
Oftalmología Médica (FOM), between June 1, 2012 and March 30,
2014, we identified those with irregular cornea and visual problems
after they underwent LASIK surgery for correcting myopia. They
presented refractive problems as it had not been totally successful
or/and they had myopic regression. None of them experienced
ocular surface disease or corneal ectasia. They were referred to
wear contact lenses from other ophthalmological centers because
of their unsatisfactory visual quality with their glasses or current
contact lenses. This study complied with the ethical requirements
set by the FOM, including only those patients who had consented
to the use of their clinical data for research purposes.
Data Collection
A comprehensive eye examination was performed on all subjects
before the fitting of MAGD CScL, which included the assessment
of VA, anterior eye biomicroscopy, ocular fundus examination,
and corneal topographic analysis using the Pentacam Eye Scanner
(Oculus Inc., Wetzlar, Germany). In addition, subjective visual
quality (SVQ) on a typical five-level Likert item (1, very poor;
2, poor; 3, neither poor nor favorable; 4, favorable; and 5, very
favorable) was also measured with their habitual glasses or contact
lenses.
To determine ocular aberrations, the Alcon LADARWave
(Custom Cornea Wavefront System; Alcon Laboratories Inc., Fort
Worth, TX) aberrometer was used. This aberrometer uses a Shack-
Hartmann sensor and was well calibrated for its use. The WFE was
measured on a pupil size of 6 mm with pharmacological
intervention for mydriasis (1% tropicamide eye drops). The system
of aberrometer uses three of five individual measurements to
determine the optimal finding. Aberrometry data include traditional
spherocylindrical refractive error, spherical equivalent, percentage
of defocus and astigmatism participation in all ocular aberrations,
and the root mean square (RMS) in terms of micrometers of
deviation, WFE (mm) of defocus, astigmatism, coma aberration,
spherical aberration, and other HOAs.
Lens Used
Patients were fitted with MAGD CScL (Scleracon; Lenticon,
Madrid, Spain). The time elapsed before fitting this lens was at
least 6 months after LASIK surgery. This lens is made up of
a highly gas-permeable material of fluorosilicone acrylate and
Oxicon extreme (Optimum extreme; Contamac Ltd, Saffron
Walden, UK). Its oxygen transmissibility (Dk) is 125·10
211
Fatt
units at 35°C (ISO/Fatt method). The average central thickness of
the lens is 0.27 mm. A plasma treatment is optional for this contact
lens. The parameters of this contact lens are as follows:
(1) Diameter, 12.60 to 13.50 mm
(2) Base curves range from 5.80 to 9.20 mm (in 0.05-mm steps)
(3) Scleral curves range from 6.80 to 11.4 mm (in 0.10-mm
steps)
(4) Power ranges from +20.00 to 225.00 D (in 0.25-D steps).
As described by the manufacturer, the design is multiaspherical
with three curves, the base curve, intermediate curve, and
peripheral curve (or scleral curve). The peripheral curve provides
stability and a centered position for this contact lens. This lens has
been designed to vault the corneal surface and limbal area, using
the bulbar conjunctiva as a platform from which to properly
position the lens. In addition, the multiaspheric design provides
a more even distribution of the lens mass across the cornea.
Fitting Procedure
All contact lenses were fitted by the trial lens method. The
diagnostic trial set consisted of 35 lenses with a diameter of 12.60
mm. The trial lens was selected with postoperative keratometry
readings by corneal topography. The first trial lens was selected
with a base curve of 0.20 mm steeper than the average keratometry,
according to the manufacturer’s suggestions. If a trial lens did not
fit correctly, it was replaced by a lens that fitted appropriately. We
looked for a good relation between the lens and the corneal surface.
Once the desired fitting relationship was observed, the lens was
allowed to settle on the eye for 30 min. Then, overrefraction was
performed to determine appropriate lens power and provide an
estimate of VA. A second step consisted in the verification of
the peripheral curve of the lens, looking for the appropriate relation
between the lenses with the bulbar conjunctiva (excessive pressure
of the lens had to be avoided). The fit was checked for good lens
position and optimum lens movement (0.50 mm), along with a good
tear exchange. Data of these steps were needed to perform the
manufacture of the lenses.
After receiving the prescribed MAGD CScL, patients were
instructed in lens care and handling. Once the lenses were inserted,
an evaluation was made after 4 hr. If these were appropriate, the
lenses were given to the patients. They were advised to increase
use 1 hr a day, until the next visit 1 week later. In this visit, VA,
SVQ, and WFE on the contact lens were assessed. Wavefront error
was assessed when the contact lens was in the best position of
centration on the cornea. Re-evaluations of these parameters were
made again at 3, 6, and 12 months.
Data Analysis
Statistical analysis was performed using SPSS 15.0 software
(SPSS Inc., Chicago, IL). A nonparametric statistical test (the
Wilcoxon test) was used to compare differences between VA and
RMS before and after MAGD CScL was fitted, in addition between
initial fitting MAGD CScL and after 1 year. All visual acuities were
converted to logMAR (logarithm of the minimum angle of
resolution) for statistical analysis. The level of statistical significance
was taken as P,0.05. Of those subjects who were fitted contact
lenses in both eyes, only the right eye was considered for analysis.
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RESULTS
Thirty-one eyes of 18 patients (10 male and 8 female) with
irregular cornea after LASIK surgery were fitted with MAGD
CScL; however, only 18 eyes (one of each patient) have been
analyzed in this study. All subjects were whites, and their ages
ranged from 27 to 39 years (mean6SD, 32.663.8 years).
Mean6SD of spherical equivalent and corneal astigmatism was
23.6561.55 and 1.6260.61 D, respectively. All patients showed
good fitting characteristics: optimal values were seen for lens posi-
tion and lens movement, and also increased VA. Statistically sig-
nificant differences were found in the VA between before and after
fitting MAGD CScL (mean6SD, 0.1460.03 logMAR [range,
0.20–0.10 logMAR] and 0.0160.06 logMAR [range, 0.10 to
20.10 logMAR], respectively; P,0.001). In addition, SVQ was
also significantly improved after fitting MAGD CScL (16 eyes
were favorable or very favorable). Table 1 summarizes demo-
graphic and clinical data of participants in this study.
Differences in second-order aberrations and HOAs between
before and after fitting MAGD CScL are shown in Table 2. After
1 year wearing MAGD CScL, no statistically significant differen-
ces were found in the total HOAs (Table 3) and VA (mean6SD,
0.0160.06 logMAR; P¼0.65) in regard to the initial fitting. In
addition, higher ratings of SVQ were kept. Therefore, improve-
ments in VA and SVQ, and reduction in HOAs were maintained
during 12 months of lens wear.
DISCUSSION
Among the reason for fitting a ScL is the application for corneal
irregularities with different etiologies including keratoconus,
postpenetrating keratoplasty, and postrefractive surgery.
14,15
Fitting
contact lenses after LASIK surgery can be a challenge especially
when other contact lenses are not well tolerated (excessive move-
ment and/or decentrated lens) because of the irregularity of the
cornea.
15
In this study, we fitted a MAGD CScL on irregular cor-
neas after LASIK surgery to achieve several advantages that this
type of lenses offers, such as excellent comfort, centration, and
stability in relation to corneal RGP lenses.
15
In this study, all patients presented an unsatisfactory SVQ with
their glasses or current contact lenses after LASIK surgery (13 eyes
were very poor or poor and 5 eyes were neither poor nor
favorable); however, after fitting MAGD CScL, they showed
a significant improvement of SVQ (16 eyes were favorable or
very favorable). In addition, all eyes improved their VA in relation
to their previous correction with statistically significant differences.
These results agree well with previous studies about the improve-
ment of VA with ScL on corneal irregularities.
16–20
Visual acuity is the most common method by which eye care
professionals assess optical image quality; however, it may be
misleading because it does not assess the visual quality related to
HOAs.
6,11
The application of WFE provides quite useful informa-
tion on the ocular optical quality. In addition, WFE on contact lens
in the eye allows determine their interaction with the tears, cornea,
and internal optics of the eye; therefore, it is useful to fit contact
lenses.
22
Factors such as lens flexure, movement, and decentration
of reduced precorneal tear film affect increasing HOAs
23,24
; there-
fore, we looked for the better fit with a MAGD CScL to achieve the
highest decrease of HOAs.
Higher-order aberrations are present in the population and depend
on various factors, mainly the pupil size and change with age.
25
Therefore, it is difficult to determine WFE in HOAs for the normal
population. In a previous study by Applegate et al.,
25
they calculated
the upper limit of 95% CI as a function of pupil size and age. For
example, the expected WFE in HOAs for a population with an
average age of 35 and a mesopic pupil size of approximately 6
mm would be 0.471 mm or less; therefore, measurements over this
level could be suspicious for abnormality, at the 95% level.
In this study, the mean age was 32.664 years, and we measured
WFE with a pupil size of 6 mm. Our results have shown that
TABLE 1. Demographic and Clinical Data of Patients
Age G Eye K1/K2/A˚ Refraction
Before Fitting CL After Fitting CL
VA
a
SVQ
b
VA SVQ
b
Case 1 32 M OD 37.12/37.62/7˚ 24.00 to 0.75·120 0.7 2 1 4
Case 2 38 F OD 35.25/36.37/16˚ 22.75 to 1.00·45 0.8 2 1.2 5
Case 3 27 F OD 37.50/38.4/94˚ 24.00 to 1.50·160 0.7 1 1.2 4
Case 4 30 F OD 38.76/39.56/11˚ 22.50 to 1.50·20 0.7 2 1 4
Case 5 36 M OD 37.50/39.37/10˚ 23.00 to 2.50·10 0.8 2 1 4
Case 6 34 M OD 37.12/38.75/170˚ 24.25 to 2.25·175 0.7 3 0.9 5
Case 7 28 F OD 38.35/39.70/140˚ 24.00 to 1.75·120 0.6 1 1 4
Case 8 36 F OD 37.62/39.70/90˚ 25.00 to 2.75·70 0.6 2 0.9 4
Case 9 31 M OD 37.90/40.24/16˚ 25.25 to 2.00·15 0.8 3 1 4
Case 10 39 M OD 39.12/41.37/18˚ 21.00 to 4.00·20 0.6 1 0.8 4
Case 11 32 M OD 37.50/39.60/145˚ 22.25 to 2.00·125 0.6 3 1.1 5
Case 12 30 F OD 41.25/42.25/176˚ 20.50 to 1.00·155 0.8 3 1.2 5
Case 13 36 F OS 39.00/40.50/17˚ 21.00 to 1.25·10 0.7 2 0.9 4
Case 14 30 M OS 38.50/40.00/171˚ 22.25 to 1.00·180 0.7 3 0.8 3
Case 15 29 M OD 40.00/41.50/91˚ 22.50 to 1.50·95 0.7 2 0.9 4
Case 16 28 M OD 39.12/41.50/10˚ 21.75 to 2.00·15 0.7 1 0.9 3
Case 17 30 M OD 37.12/39.60/86˚ 22.50 to 2.00·90 0.7 2 1 5
Case 18 38 F OD 41.62/43.50/16˚ 21.50 to 2.25·25 0.7 2 1 4
a
Decimal VA values with their habitual glasses or contact lens.
b
Subjective visual quality was graded as 1, very poor; 2, poor; 3, neither poor nor favorable; 4, favorable; and 5, very favorable.
CL, contact lens; G, gender; M, male; F, female; K1/K2/A˚, the power of corneal meridians and axis; VA, visual acuity; SVQ, subjective visual
quality.
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spherical and coma aberrations (mean6SD, 0.6760.26 mm and
0.5260.26 mm, respectively) were the most important HOAs,
agreeing well with previous studies.
6,12,13,17
After fitting MAGD
CScL, these HOAs had an important reduction to normal levels,
and also the total HOAs (an average of 78% reduction). In previous
studies, Gemoules and Morris
17
fitted a corneo-SCL with a reverse
geometry design and found a reduction in the total HOAs of 66%
with different pupil sizes. Tan et al.
13
fitted a spherical RGP on
a pupil size of 6 mm and found a reduction in the total HOAs of
69%; however, when WFE was taken, they used their fingers to
ensure that the contact lens was located in the center of the cornea.
In another study, Tan et al.
12
used a RGP with a reverse geometry
and also found 69% of reduction in the total HOAs. These studies
show percentages of reduction HOAs, which are lower than our
findings, although it should be noted that they cannot be strictly
compared.
These favorable findings of this study could be due to better
centration and stability of these lenses, along with their MAGD.
This design allows compensate the oblate shape of cornea after
LASIK surgery. In addition, the tear lens between the posterior
surface of contact lens and the anterior surface of the cornea plays
an important role in compensating corneal irregularities.
After 1 year wearing MAGD CScL, no statistically significant
differences were found in coma aberration, spherical aberration,
total HOAs, and VA in regard to the initial fitting. This could be
due to the parameters of contact lenses remaining stable and
therefore continuing to show good fit characteristics. In addition,
an appropriate corneal tear film was also maintained, and also no
adverse events in the cornea were manifested. Previous studies
have determined that oxygen availability is important to consider in
relation to ScL.
26
The new materials with high oxygen permeability
and reduced central thicknesses may resolve or diminish the inci-
dence of corneal edema. Another important option, whenever clin-
ically reasonable, is fitting smaller diameter lenses because they are
more likely to fulfill the oxygen requirements of the cornea, as they
tend to favor tear exchange under the lens. These favorable factors
that are present in MAGD CScL show that these contact lenses are
proposed as a safe and effective procedure fitted on irregular cor-
neas in subjects who underwent LASIK surgery.
Future studies with a greater sample size when fitting MAGD
CScL on irregular corneas will be needed for patients who present
poor visual quality after LASIK surgery to confirm our results.
In summary, the irregular cornea after LASIK surgery in some
myopic subjects creates the need for a contact lens correction to
improve the quality of vision. The results of this study show that
fitting MAGD CScL is an effective procedure, providing an
optimal visual quality.
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TABLE 2. Differences in Ocular Aberrations Between Before and After
Fitting a Corneoscleral Contact Lens With Multiaspheric Geometry
Design (18 Eyes With a Pupil Diameter of 6 mm)
Parameter
Before Fitting CL,
Mean6SD, mm
After Fitting CL,
Mean6SD, mm DA, % P
a
Second-order
aberrations
0.9260.22 0.1860.11 280 ,0.001
Coma
aberrations
0.5260.26 0.1860.14 265 ,0.001
Spherical
aberrations
0.6760.26 0.1660.13 276 ,0.001
Other HOAs 0.1660.05 0.1460.04 212 0.45
Total HOAs 1.0960.26 0.2460.14 278 ,0.001
a
Pvalue from the Wilcoxon test.
HOAs, higher-order aberrations; CL, contact lens; DA, decreased
ocular aberrations in percentages.
TABLE 3. Differences in Ocular Aberrations After 1 Year Wearing
Corneoscleral Contact Lens With Multiaspheric Geometry Design in
Regard to the Initial Fitting (18 Eyes With a Pupil Diameter of 6 mm)
Parameter
Initial,
Mean6SD, mm
After 1 yr,
Mean6SD, mmP
a
Second-order aberrations 0.1860.11 0.2360.14 0.17
Coma aberrations 0.1860.14 0.2260.19 0.55
Spherical aberrations 0.1660.13 0.1860.12 0.61
Other HOAs 0.1460.04 0.1160.08 0.09
Total HOAs 0.2460.14 0.3160.24 0.17
a
Pvalue from the Wilcoxon test.
HOAs, higher-order aberrations.
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