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Contact Lens & Anterior Eye 37 (2014) 377381

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Contact Lens & Anterior Eye


journal homepage: www.elsevier.com/locate/clae

Soft contact lens tting after intrastromal corneal ring segment


implantation to treat keratoconus
b , D. Diaz-Valle b , J.M. Vazquez a ,
J. Carballo-Alvarez a, , M.C. Puell a , R. Cuina
b
J.M. Benitez-del-Castillo
a
b

Applied Vision Research Group, Faculty of Optics, Universidad Complutense de Madrid, 28037 Madrid, Spain
Hospital Clinico San Carlos, 28037 Madrid, Spain

a r t i c l e

i n f o

Article history:
Received 3 December 2013
Received in revised form 1 June 2014
Accepted 4 June 2014
Keywords:
Keratoconus
Intrastromal rings
Soft toric contact lens
Piggy back

a b s t r a c t
Purpose: To assess the feasibility of tting a lathed soft toric contact lens (STCL) after the implant of
intrastromal corneal ring segments (ICRSs) to treat keratoconus.
Methods: Six months after ICRS implantation, 47 eyes of 47 patients (1845 years) were tted with a STCL.
In each eye, we determined refractive error, uncorrected (UDVA) and corrected distance visual acuity
(CDVA), and keratometry and asphericity measures. The outcome of STCL tting was dened according
to CDVA as successful (0.2 logMAR) or unsuccessful (>0.2 logMAR). Patients in the unsuccessful group
were retted with a piggy-back (PB) system. The above variables and the change in CDVA observed after
STCL and PB lens tting from spectacle CDVA were compared in the two groups.
Results: STCL tting was successful in 75%, 66.66% and 0% of the ICRS implanted eyes with stages IIII
keratoconus, respectively. Spectacle-CDVA was 1.5 lines better and mean corneal power was 3.62D lower
in the successful STCL group. In this group, the difference in cylinder axis between spectacles and STCL
was 24.25 lower. PB retting achieved a PB-CDVA 0.2 logMAR in all cases. A similar difference in the
CDVA change achieved by contact lenses versus spectacles was observed in the successful STCL and PB
retted groups.
Conclusion: STCL tting is a feasible option in a large proportion of patients implanted with ICRS. When
these lenses are unsatisfactory, a PB system is a good alternative.
2014 British Contact Lens Association. Published by Elsevier Ltd. All rights reserved.

1. Introduction
Keratoconus occurs when the cornea thins and gradually bulges
to acquire the shape of a cone. The outcome of corneal thinning
and protrusion is regular or irregular astigmatism, high-order aberrations and vision loss [1]. The surgical implant of intrastromal
corneal ring segments (ICRSs) attens the cone and reinforces the
cornea [2,3], and this reduces astigmatism and corneal high-order
aberrations (HOAs) in patients with clear corneas. These effects
of ICRS are the consequence of regularization of the corneal surface. Following ICRS placement, good visual acuity is commonly
achieved using a rigid gas permeable (RGP) lens. RGP lenses are
able to mask much of the corneal aberration present by replacing
the irregular cornea with the regular refractive surfaces of the RGP

Corresponding author at: Faculty of Optics, Complutense University of Madrid,


Department of Optics II (Optometry and Vision), Calle Arcos del Jalon 118, 28037
Madrid, Spain. Tel.: +34 913946887.
E-mail addresses: jcarballo@ucm.es, jcarball@opt.ucm.es (J. Carballo-Alvarez).

and tear lens [4]. Carrasquillo [5] and Shetty [6] reported that tolerance to RGP lenses was improved after ICRS implantation, though
other authors have described the opposite trend [7,8]. According
to Reinstein et al., complications are possible due to modications
to the stroma and epithelium in the ring zone [9]. They showed
changes in epithelial thickness over and around the ring implant.
Also the space occupying effect of the ICRS showed forward arching
of stromal tissue, whereas the posterior surface is similarly arched
inward. Other studies [10,11] have shown that the piggy-back system, whereby a RGP lens is tted over a soft contact lens, is a safe
way to achieve corneal integrity and good centering of the RGP lens.
Soft contact lenses offer certain advantages over RGP lenses such
as comfort, better psychological acceptance and improved corneal
integrity. Other lens modalities used on irregular corneas including scleral RGP, high thickness soft contact lenses or hybrid contact
lenses are an alternative option in contact lens tting after ICRS
implantation [12].
By correcting or inducing aberrations, it is possible to change
the natural aberration pattern of the eye. Increased HOA impair
visual function [13] and the accommodation response [14]. In

http://dx.doi.org/10.1016/j.clae.2014.06.001
1367-0484/ 2014 British Contact Lens Association. Published by Elsevier Ltd. All rights reserved.

378

J. Carballo-Alvarez et al. / Contact Lens & Anterior Eye 37 (2014) 377381

theory, the full correction of HOA, as pursued when RGP lenses


are tted, improves visual acuity over a large range of luminances
and contrast polarities (black letters on white background, and
white letters on black background) [15], and also improves contrast sensitivity [16,17] and performance at functional visual tasks
[18]. However, previous studies have shown that the visual acuity
achieved using a soft contact lens is often better than the outcome
predicted by aberrometry coefcients [19] such as the root mean
square (RMS). In addition, a relatively large extent of HOA is still
observed after tting RGP lenses, and this translates to worse visual
performance [20,21] attributable to factors such as irregular posterior cornea effects [22], interactions between aberrations [23], the
post surgery tear lm or neural adaptation [24,25]. It is thus possible that contact lenses that only partly correct anterior corneal
surface HOA, such as soft toric contact lenses (STCLs), may offer a
good visual outcome and could thus be an alternative to RGP in
cases of an irregular cornea. As previously observed in eyes with an
irregular cornea [5,2628], our clinical experience indicates that in
some patients, STCL, besides offering high comfort, lead to a better
visual acuity than that predicted by corneal HOA indicators.
Few studies have addressed the issue of contact lenses tting
in ICRS implanted keratoconic eyes [68,10,11,28] and most have
examined only a small number of eyes. Some studies have investigated the use of soft contact lenses in eyes with keratoconus and an
irregular cornea. The results of these studies indicate that most HOA
variables are reduced [27,29], although posterior cornea HOA persist [30], and vertical coma and spherical aberration parameters are
modied [31,32]. Due to their greater diameter than the cornea, soft
contact lens centering could be easier in ICRS-implanted corneas
than in keratoconic eyes given the centered apex and regular surface produced after surgery even when used to treat advanced stage
disease.
The aim of this study was to assess the feasibility of tting
lathed soft contact lenses in 47 eyes implanted with KeraRing ICRS.
Spectacle-corrected distance visual acuity (CDVA) and refraction
and corneal variables were compared in eyes successfully or unsuccessfully tted with soft toric (STCL) or spheric (SSCL) contact lenses
and eyes retted with a piggy-back lens system. We also compared
the change relative to spectacle CDVA produced after tting each
type of contact lens.
2. Patients and methods
The nal sample included 47 eyes of 47 patients (20 women, 27
men) aged 1845 years, who had been implanted with KeraRing
ICRS (Mediphacos, Brazil) with an optic zone of 5 mm using a manual technique as described in our previous study [33]. Surgery was
performed at the Hospital Clinico San Carlos, Madrid.
The study protocol adhered to the tenets of the Declaration of
Helsinki and Spanish legislation and was approved by the Ethics
Committee of the Hospital Clnico San Carlos, Madrid. Written
informed consent was obtained from all of patients before the study
outset.

cylinder (K-cyl) and mean keratometric values (KM3) in diopters


(D) for the central 3 mm. Asphericity was estimated at 4.5 mm
(Q45).
Visual acuity was measured with best spectacle correction and
after contact lens tting under photopic (85 cd/m2 ) luminance
conditions, using BaileyLovie logMAR letter Charts [34] at high
contrast (96%).
All the patients were tted with lathed soft toric contact lenses
(STCLs). The lens material was hioxylcon A with a 59% water content and modulus of 0.30 MPA (Mark Ennovy Laboratories, Madrid).
The center thickness measured for 3.00 D was 0.14 mm. The back
lens surface has a spherical 10.00 mm diameter optic zone. Prism
characteristics are inferior base 0.92 prismatic diopters and diameter 14.50 mm. The initial base curve (BC) was calculated (between
8.00 and 8.60 in 0.30 mm steps) by the manufacturer from the
central keratometric radius at 3 mm. Initial lens power was calculated from the refraction, taking distometry into account when
necessary. After 2 h of tting, lens centering was assessed. When
required the BC was changed to better center the lens with a rotation under 5 . Next, we over-refracted and if a VA improvement
was observed a new STCL was prepared based on the lens power
plus the over-refraction, with a new sphere, cylinder and axis. This
process was repeated to check for a VA improvement and if this
occurred another new lens was prepared and the process repeated
up to two more times.
In 4 of the 47 eyes, the calculation after over-refraction resulted
in a cylinder lower than 0.75 D. These eyes were therefore tted
with a lathed soft spherical contact lens (SSCL). In the remaining 43
eyes, an STCL was used and 2 study groups established according
to CDVA: a group of 22 successfully tted eyes (VA better or equal
to 0.2 logMAR, better than the European Driving Standard), and a
group of 21 eyes unsuccessfully tted with STCL (VA worse than
0.2 logMAR). Eyes in the unsuccessfully STCL tted group were retted with a piggy-back (PB) system consisting of a RGP lens over
a daily disposable soft contact lens. The RGP lens (Lenticon Laboratories, Madrid) had a 5 mm-diameter spherical optic zone and
an outer zone with an aspherical curve which was 0.601.00 mm
atter. The most peripheral band was 1 mm wide, with a curve
of 12.60 mm. Overall lens diameter ranged from 8.70 to 9.40 mm.
The material used was HDS (Paragon, USA) with a Dk of 58. The
daily disposable contact lens used was an omalcon-A aspherical lens of 8.70 mm BC, sphere +0.50 and diameter 14.20 mm. The
friction coefcient of this material is 0.09 0.033 at 0 cycles [35]
determining that movement of the RPG lens is independent of soft
lens movement. This type of lens was selected since its thickness
(0.09 mm at 3.00 D) is similar to that of a conventional contact
lens, and its topography revealed a more regular surface facilitating
RPG tting.
After 1 month of wearing the contact lenses nally tted, corneal
integrity was checked in a slit-lamp biomicroscopy exam using
sodium uorescein to compare the topographic map with the map
obtained before lens tting.
In addition, the topographic map was compared with the map
obtained before lens tting.

2.1. Clinical procedures

2.2. Statistical analysis

Keratoconus was stage I in 12 of the eyes (25.5%), stage II


in 21 eyes (44.8%) and stage III in 14 eyes (29.7%) according
AmslerKrumeich classication. Six months after surgery, all the
patients underwent an ophthalmic examination at the Faculty of
Optics and Optometry, Universidad Complutense de Madrid. In this
exam, measurements of uncorrected (UDVA) and corrected (CDVA)
distance visual acuity were made using a trial frame and trial
lens set by the same optometrist. The topographic variables measured using the Pentacam (Oculus, Germany) were: keratometric

The normality of data was checked using the Kolmogorov


Smirnov test, which indicated a normal distribution of all variables.
The Wilcoxon rank-sum test was used to compare spectaclecorrected visual/refractive and topographic outcomes between the
successful and unsuccessful STCL tting groups, mean changes in
visual/refractive outcomes between spectacles and tted contact
lenses in both STCL tting groups, and the mean CDVA change
produced in response to contact lens tting for the STCL versus
the PB tted eyes. Visual and refractive variables were compared

J. Carballo-Alvarez et al. / Contact Lens & Anterior Eye 37 (2014) 377381


Table 1
Patient data after ICRS implantation. Mean SD.
Sphere (D)
Cylinder (D)
UDVA (logMAR)
CDVA (logMAR)
KM3 (D)
Q45

2.18
3.11
0.74
0.25
47.70
1.69

4.75
1.90
0.38
0.15
4.65
1.45

UDVA: uncorrected distance visual acuity; CDVA: corrected distance visual acuity;
KM3: mean corneal power in the 3.00 mm central zone; Q45: mean asphericity in
the 4.5 mm diameter central corneal zone.

between spectacles and contact lenses using the Students t-test for
paired data. All statistical tests were performed using Statgraphics
Centurion XVI software. Signicance was set at p < 0.05.

379

(2.39 1.13 D). Finally, we also detected a signicant difference


between the spectacle cylinder axis and the cylinder axis of the
nally tted STCL (p = 0.00002). In the unsuccessfully tted group, a
signicant difference only emerged in the mean difference between
the spectacle axis and the STCL axis (p = 0.0004). In all cases the rotation of the lens was lower or equal than 5 , furthermore the axis
change after over refraction was not consistent with the centered
of the lens.
When we compared the changes produced in the successful and
unsuccessful tting groups, the mean difference between the spectacle cylinder axis and the nal STCL cylinder axis (p = 0.001) was
24.25 higher in the unsuccessful group (p = 0.001).
In addition, the BC of the tted STCL was 8.33 0.16 mm
(8.008.60) in the successful group versus 8.13 0.15 mm in the
unsuccessful group (8.008.30) (p = 0.0004).

3. Results
Mean values (SD) of refractive error, logMAR UDVA, logMAR
CDVA and topographic outcomes determined 6 months after surgical ICRS implantation for the 47 eyes included in the study are
provided in Table 1. Pre- and post surgery values for these patients
have been reported in a previous study (Tables 1 and 2) [36], in
which we determined visual function after ICRS implantation in
the same keratoconic eyes.
3.1. STCL tting
Table 2 shows spectacle logMAR CDVA, and refractive, visual and
topographic outcomes of ICRS implantation in eyes subsequently
classied as successfully or unsuccessfully tted with a STCL. These
results indicate signicant differences between the two groups in
CDVA (p = 0.004) and mean corneal power at 3 mm (p = 0.03). Thus,
spectacle CDVA was 1.4 logMAR lines better in the unsuccessfully
tted group and mean corneal power at 3 mm was 3.62 D lower in
the successfully tted group.
Next, we compared mean differences in visual and refractive
variables after STCL tting compared to spectacle values in the successful and unsuccessful tting groups (Table 3). In the successful
tting group, the mean increase in spectacle CDVA was signicantly
higher (0.17 0.08) than that observed in STCL CDVA (0.10 0.07)
respectively (p = 0.003). Also a mean difference in the cylinder value
was recorded for spectacles (2.77 1.42 D) compared to STCL

3.2. Eyes unsuccessfully tted with a STCL re-tted with a PB


system
In the 20 eyes unsuccessfully tted with a STCL and retted with
a piggy-back system, we recorded a logMAR contact lens CDVA
equal or better than 0.2 with a mean of 0.09 0.08 (0.08 to 0.2). For
the RGP lenses used as piggy backs, mean BC was 6.87 0.46 mm
(6.307.20), mean diameter was 9.29 0.20 mm (9.209.40) and
mean peripheral eccentricity was 0.95 0.17 mm (0.61.2).

3.3. Eyes tted with SSCL


Remarkably, 4 eyes were satisfactorily tted with a SSCL without
cylindrical correction. In these eyes, VA was better than 0.2 logMAR.
The keratometric cylinder calculated by the topographer in the
central 3 mm was 2.75, 3.50, 3.75 and 4.50 D, and spectacle cylinder was 0.25, 1.50, 1.75 and 2.00 D for the four
eyes, respectively. Thus, the annulled cylinder of the contact lenses
was not as predicted. The topographer-estimated keratometric axis
was similar to the spectacle axis in all four eyes, the mean difference being only 3.75 2.50 . Mean lens BC was 8.37 0.15 mm
(8.308.60). Probably this correction of the cylinder and HOA values are due to the thickness and the modulus of the contact lens
and the results would be different with a different material.

Table 2
Visual, refractive and topographic outcomes of ICRS implantation in eyes subsequently successfully and unsuccessfully tted with a STCL. Mean SD (max, min).
Successful (n = 22)
Spectacle CDVA (logMAR)
Sphere (D)
Cylinder (D)
K-Cyl (D)
KM3 (D)
Q4.5

0.17
0.52
2.77
3.47
46.21
1.44

Unsuccessful (n = 21)

0.08 (0.04, 0.38)


2.53 (7.50, 3.00)
1.42 (6.00, 1.00)
1.66 (0.80, 6.30)
3.55 (39.55, 53.55)
1.14 (3.34, 0.36)

0.31
3.31
3.85
3.86
49.83
1.49

0.17 (0.08, 0.72)


5.41 (14.50, 6.00)
2.24 (11.00, 1.00)
1.95 (0.30, 7.20)
5.24 (39.65, 59.45)
2.11 (4.51, 2.71)

CDVA: corrected distance visual acuity. K-Cyl: difference in the corneal power of the 3.00 mm central zone. KM3: mean corneal power in the 3.00 mm central zone. Q45:
mean asphericity in the 4.5 mm central zone.

A statistically signicant difference (p < 0.05).


Table 3
Visual and refractive changes produced after STCL tting compared to spectacle values in the successfully and unsuccessfully tted groups. Mean SD (max, min).
Successful (n = 22)
CDVA (logMAR)
Sphere (D)
Cylinder (D)
Axes dif.

0.07
0.22
0.39
4.50

0.09* (0.10, 0.28)


0.92 (3.75, 0.75)
0.55* (0.25, 2.00)
9.98* (0.00, 35.00)

CDVA: corrected distance visual acuity. Axes dif: difference between spectacle axis and STCL axis.
*
A statistically signicant change (p < 0.05).

A statistically signicant difference between the successful and unsuccessful groups.

Unsuccessful (n = 21)
0.02
0.42
0.59
28.75

0.20 (0.48, 0.32)


2.30 (5.75, 4.50)
1.94 (2.00, 5.50)
30.17* , (0.00, 90.00)

380

J. Carballo-Alvarez et al. / Contact Lens & Anterior Eye 37 (2014) 377381

Fig. 1. LogMAR CDVA (mean, SD) for spectacles and each of the contact lenses tted.
* A statistically signicant difference.

Fig. 2. Percentages of each type of contact lens nally tted according to keratoconus stage prior to ICRS implantation surgery.

3.4. Comparing spectacle CDVA and DVA corrected using the


different contact lenses
We then went on to compare mean logMAR CDVA values
obtained for spectacles versus each of the different contact lenses
tted (Fig. 1). The mean logMAR CDVA increase produced after
contact lens tting was 0.07 0.09 logMAR in the STCL group
(p = 0.003). No differences were detected according to keratoconus
stage prior to surgery. In the eyes tted with a PB system, the
mean logMAR CDVA increase was 0.23 0.16 logMAR (p = 0.00),
again with no effects of prior keratoconus stage. Finally, the mean
increase produced in CDVA was 0.14 0.12 logMAR in the SSCL
group. This variable was 1.15 logMAR lines higher in the PB than
the STCL group (p = 0.003).
Fig. 2 shows the percentages of eyes nally tted with each
contact lens type according to the keratoconus stage prior to ICRS
implantation: for stage I, 1 eye (8.33%) received a SSCL, 9 (75%) eyes
a STCL and 2 eyes (16.66%) a PB system; for stage II, 1 eye (4.76%)
received a SSCL, 14 eyes (66.66%) a STCL and 6 eyes (28.57%) a PB
system; and for stage III, 2 eyes (14.28%) received a SSCL and 12
eyes (85.71%) a PB system.
In no eye were signicant effects of 1 months wear of each
type of contact lens produced on corneal surface integrity and the
topographic map.
4. Discussion
Only a few studies have addressed contact lens tting in ICRS
implanted keratoconic eyes, and most have examined only a small
number of eyes [7,8,10,28]. Several studies have shown that customized soft contact lenses [30,37,38] used to correct HOA in

aberrated eyes offer visual benets over their use in normal eyes.
However, some authors [29,39] warn that the visual benet for an
abnormal eye is more sensitive to decentration and rotation of customized optics compared to normal eyes. In the present study, we
used non-customized lathed soft contact lenses. The lathe-cut elaboration method gives rise to a lens with precise, highly reproducible
properties inducing minimal rotation, translation and decentration
[20,29,40]. Further benets of these soft contact lenses are an easy
manufacturing process thereby reducing costs, their easy access,
along with acceptable comfort and simple handling for the patient.
When spectacle visual outcomes were compared in the successfully and unsuccessfully STCL tted groups, mean spectacle
CDVA was signicantly better in the successful than the unsuccessful group and mean corneal power in the central 3 mm was
also lower in the successful group. Accordingly, eyes successfully
tted with a STCL were more often those at a moderate stage of keratoconus (Fig. 2) or those in which the surgery outcome had been
more satisfactory. The good STCL-CDVA observed in this group of
eyes may be attributed to their better spectacle CDVA or to a greater
VA improvement produced after contact lens tting.
The refractive powers of the tted soft contact lenses were not
as predicted by spectacle power and vertex distance. As shown in
Table 3, the contact lenses did not show the expected more positive power than spectacle power in many cases, although there was
high variability between eyes. A possible explanation for this is that
the optical quality of the eye plus contact lens, besides depending
on the optics of the eye, will also depends on the optical properties
of the lens and its interaction with the cornea and tear lm (probably the power of the lacrimal lens is related to the modulus of the
contact lens and is possible to change the nal power with different
materials). Further inuential factors include partial correction of
anterior corneal surface HOA by the soft contact lens, interactions
between low and high order aberrations at the two corneal surfaces, and nally rotation and translation effects. In our study, the
successfully STCL tted group showed a atter BC and in no case
was a BC of 8.00 mm needed for improved tting. This could have
determined better interaction between the contact lens, tear lm
and corneal surface.
Our results indicate that the better CDVA were usually detected
when only minor changes to the cylinder axis had to made to the
new lens according to the over-refraction performed on the rst
STCL tted, although sphere and cylinder power had to be changed.
This occurs more frequently in cases of a atter cornea and lower
spectacle refraction. Thus, the mean difference between the cylinder axes of the spectacles and nal STCL tted was only 4.50 9.99
in the successfully STCL tted group. In contrast, in the unsuccessfully STCL tted group, although the refraction over the rst STCL
tted achieved a substantially better VA, the new calculated STCL
did not show the same good result, especially when there was a signicant difference between the spectacle and STCL axes (Table 3).
Similarly, Nepomuceno et al. [28] described a case of a patient with
Intacs tted with a molded soft toric contact lens. Spectacle refraction was 1.25 sphere, 5.00 cylinder and VA was 0.12 logMAR.
However, nal contact lens power was 2.00 sphere, 1.25 cylinder, VA was 0.08 logMAR and BC 8.70 mm. In agreement with
our ndings, STCL refractive power and the signicantly improved
VA were not those expected for soft contact lenses in eyes with a
regular cornea.
Results for our patients retted with a piggy-back system
revealed this to be a good option when STCL tting did not achieve
a logMAR VA better than 0.2. In effect, this option mostly corresponded to the eyes at the more advanced keratoconus stages with
greater HOA, in which surgery had a reduced regularizing and attening effect. The mean increase in CDVA after PB tting did not
vary signicantly from that observed for the STCL, though outcomes
were highly variable between eyes. It should be noted that handling

J. Carballo-Alvarez et al. / Contact Lens & Anterior Eye 37 (2014) 377381

a PB system is slightly more cumbersome for the patient. The literature describes a case of a keratoconic eye implanted with ICRS
Intacs and tted with a piggy-back contact lens system [10,11].
Consistent with our observations, the authors Smith and Carrell
[11] reported no complaints of irritation or keratitis using a daily
soft contact lens and a moderately high Dk material to maximize
oxygen transfer while maintaining good lens stability and avoiding corneal reshaping. Other authors opt for a RGP lens with no
PB. Carrasquillo et al. [5] satisfactorily used this strategy in 7 ICRS
implanted eyes, while Kymionis and Kontadakis reported a severe
corneal vascularization response. In this study, we used positivepowered soft lenses (+0.50 sphere) to give slightly more thickness
over the implant zone and reduce the pressure of RPG lens movement, although the difference with a plano lens are not signicant.
Moreover, this strategy led to a slightly regular anterior corneal
surface as can be observed comparing the topographies before and
after the contact lens tting.
The present cases of eyes successfully tted with a spherical
soft contact lens are surprising given the signicant keratometric cylinders calculated by the topographer. These were, however,
lower in the spectacles and unnecessary in the SSCL. In all cases,
topographer-calculated and spectacle cylinder axes were similar.
Hence, SSCL could be an option for the practitioner managing this
type of patient, who would in theory require cylindrical powered
and HOA contact lenses.
The main limitation of our study was the great variability
observed in the results. As addressed in other settings of an irregular
cornea, in future work it would be interesting to examine corneal
surface interactions between low and high order aberrations, along
with the effects on nal vision of the tear lm, neural adaptation
and the type of contact lens used in ICRS implanted eyes.
In conclusion, soft contact lenses are a viable option for good
vision and comfort in a signicant proportion of KeraRing ICRS
implanted eyes. In eyes in which this type of contact lens proves to
be inadequate, a piggy-back system could be a satisfactory option.
Funding
None.
Conict of interest statement
No conict of interest.
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