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Contact Lens & Anterior Eye37 (2014) 377–381
Contents lists available at ScienceDirect
Contact Lens & Anterior Eye
j ournal homepage: www.elsevier .com/ locate /c lae
Soft contact lens fitting after intrastromal corneal ring segmentimplantation to treat keratoconus
J. Carballo-Alvareza,∗, M.C. Puella, R. Cuiñab, D. Diaz-Valleb, J.M. Vazqueza, J.M. Benitez-del-Castillob
a Applied Vision Research Group, Faculty of Optics, Universidad Complutense de Madrid, 28037Madrid, Spainb Hospital Clinico SanCarlos, 28037Madrid, 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 fitting a lathed soft toric contact lens (STCL) after the implant of
intrastromal corneal ring segments (ICRSs) to treat keratoconus.
Methods: Sixmonths after ICRS implantation, 47 eyes of 47patients (18–45years)were fittedwith 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 fitting was defined according
to CDVA as successful (≤0.2 logMAR) or unsuccessful (>0.2 logMAR). Patients in the unsuccessful group
were refitted with a piggy-back (PB) system. The above variables and the change in CDVA observed after
STCL and PB lens fitting from spectacle CDVAwere compared in the two groups.
Results: STCL fitting was successful in 75%, 66.66% and 0% of the ICRS implanted eyes with stages I–III
keratoconus, respectively. Spectacle-CDVAwas 1.5 lines better andmean corneal powerwas 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 refitting 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
refitted groups.
Conclusion: STCL fitting 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 occurswhenthecornea thins andgradually bulges
to acquire the shape of a cone. The outcome of corneal thinning
andprotrusion is regularor irregularastigmatism,high-order aber-
rations and vision loss [1]. The surgical implant of intrastromal
corneal ring segments (ICRSs) flattens 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 sur-
face. 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 corneawith theregular refractive surfaces of the RGP
∗ Corresponding author at: Faculty of Optics, Complutense University ofMadrid,
Department of Optics II (Optometry and Vision), Calle Arcos del Jalon 118, 28037
Madrid, Spain. Tel.: +34913946887.
E-mail addresses: [email protected], [email protected] (J. Carballo-Alvarez).
andtear lens [4]. Carrasquillo [5] andShetty [6] reported thattoler-
ance 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 tomodifications
to the stroma and epithelium in the ring zone [9]. They showed
changes in epithelial thickness over and around the ring implant.
Also thespace occupying effectof the ICRS showedforwardarching
of stromal tissue, whereas theposterior surface is similarly arched
inward. Other studies [10,11] haveshown that the piggy-back sys-
tem,whereby a RGP lens is fitted over a soft contact lens, is a safe
waytoachieve corneal integrityandgoodcenteringof theRGPlens.
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 includ-
ingscleral RGP, high thicknesssoft contact lensesorhybridcontact
lenses are an alternative option in contact lens fitting 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. Publishedby Elsevier Ltd. All rightsreserved.
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theory, the full correction of HOA, as pursued when RGP lenses
are fitted, 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 con-
trast 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 coefficients [19] such as the root mean
square (RMS). In addition, a relatively large extent of HOA is still
observedafterfittingRGP lenses, andthistranslatestoworsevisual
performance[20,21]attributableto factors such as irregularposte-
rior cornea effects [22], interactions between aberrations [23], the
post surgery tear film or neural adaptation [24,25]. It is thus pos-
sible 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
casesof an irregularcornea. Aspreviously observed ineyeswith an
irregular cornea [5,26–28], ourclinical experience indicates that in
some patients, STCL, besides offering high comfort, lead to a better
visual acuity than that predictedby corneal HOA indicators.
Few studies have addressed the issue of contact lenses fitting
in ICRS implanted keratoconic eyes [6–8,10,11,28] andmost have
examined only a small numberof eyes. Some studies have investi-
gatedtheuseof soft contact lenses ineyeswith keratoconusand anirregularcornea.The resultsof thesestudiesindicate thatmostHOA
variables are reduced [27,29], although posterior corneaHOAper-
sist [30], andverticalcomaand sphericalaberrationparametersare
modified[31,32].Duetotheirgreaterdiameterthan thecornea,soft
contact lens centering could be easier in ICRS-implanted corneas
than in keratoconic eyes given the centered apex and regular sur-
faceproducedaftersurgeryevenwhenused totreatadvancedstage
disease.
The aim of this study was to assess the feasibility of fitting
lathedsoft contact lenses in47eyes implantedwithKeraRing ICRS.
Spectacle-corrected distance visual acuity (CDVA) and refraction
andcornealvariableswerecomparedineyessuccessfullyorunsuc-
cessfullyfittedwithsoft toric (STCL)orspheric(SSCL) contactlenses
and eyes refittedwith a piggy-back lens system.Wealsocomparedthe change relative to spectacle CDVA produced after fitting each
type of contact lens.
2. Patients and methods
The final sample included47eyes of 47patients (20women, 27
men) aged 18–45 years, who had been implanted with KeraRing
ICRS (Mediphacos, Brazil) withanoptic zoneof 5mmusing aman-
ual technique as described in ourprevious study [33]. Surgery was
performed at theHospital 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 Clínico San Carlos, Madrid. Written
informedconsentwasobtainedfromallofpatientsbefore thestudy
outset.
2.1. Clinical procedures
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
Amsler–Krumeich classification. Six months after surgery, all the
patients underwent an ophthalmic examination at the Faculty of
OpticsandOptometry, UniversidadComplutensedeMadrid. In this
exam,measurements of uncorrected (UDVA)andcorrected(CDVA)
distance visual acuity were made using a trial frame and trial
lens set by the same optometrist. The topographic variables mea-
sured using the Pentacam (Oculus, Germany) were: keratometric
cylinder (K-cyl) and mean keratometric values (KM3) in diopters
(D) for the central 3mm. Asphericity was estimated at 4.5mm
(Q45).
Visual acuitywasmeasured with best spectacle correction and
after contact lens fitting under photopic (85cd/m2) luminance
conditions, using Bailey–Lovie logMAR letter Charts [34] at high
contrast (96%).
All thepatientswere fittedwith lathedsoft toric contact lenses
(STCLs). The lens material was hioxyfilcon Awith a 59% water con-
tent andmodulusof 0.30MPA(Mark EnnovyLaboratories,Madrid).
Thecenter thickness measured for−3.00Dwas 0.14mm. Theback
lens surface has a spherical 10.00mm diameter optic zone. Prism
characteristics are inferior base 0.92 prismatic diopters and diam-
eter 14.50mm.Theinitial base curve (BC)was calculated(between
8.00 and 8.60 in 0.30mm steps) by the manufacturer from the
central keratometric radius at 3mm. Initial lens power was cal-
culated from the refraction, taking distometry into account when
necessary. After 2h of fitting, lens centering was assessed. When
required the BCwas changed to better center the lenswith a rota-
tion 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 newsphere, cylinderandaxis. This
process was repeated to check for a VA improvement and if this
occurred another newlens was prepared andtheprocess repeatedup to two more times.
In 4 of the47eyes, thecalculation after over-refraction resulted
in a cylinder lower than−0.75D. These eyes were therefore fitted
with a lathedsoft sphericalcontact lens (SSCL). In the remaining43
eyes, an STCL was used and 2 study groups established according
to CDVA: a group of 22 successfully fitted eyes (VA better or equal
to 0.2 logMAR, better than the European Driving Standard), and a
group of 21 eyes unsuccessfully fitted with STCL (VA worse than
0.2logMAR). Eyes in theunsuccessfully STCL fitted group were re-
fitted with a piggy-back (PB) system consisting of a RGP lens over
a daily disposable soft contact lens. The RGP lens (Lenticon Lab-
oratories, Madrid) had a 5mm-diameter spherical optic zone and
an outer zone with an aspherical curve which was 0.60–1.00mm
flatter. The most peripheral band was 1mm wide, with a curveof 12.60mm. Overall lens diameter ranged from 8.70 to 9.40mm.
The material used was HDS (Paragon, USA) with a Dk of 58. The
daily disposable contact lens used was an omafilcon-A aspheri-
cal lens of 8.70mm BC, sphere +0.50 and diameter 14.20mm. The
friction coefficient of this material is 0.09±0.033 at 0 cycles [35]
determining thatmovement of theRPG lens is independent of soft
lens movement. This type of lens was selected since its thickness
(0.09mm at −3.00D) is similar to that of a conventional contact
lens,and itstopographyrevealedamoreregularsurface facilitating
RPG fitting.
After1monthofwearingthecontactlensesfinallyfitted,corneal
integrity was checked in a slit-lamp biomicroscopy exam using
sodiumfluorescein to compare the topographicmapwith the map
obtained before lens fitting.In addition, the topographic mapwas compared with the map
obtained before lens fitting.
2.2. Statistical analysis
The normality of data was checked using the Kolmogorov–
Smirnov test,which indicated a normaldistributionof allvariables.
The Wilcoxon rank-sum test was used to compare spectacle-
correctedvisual/refractiveand topographicoutcomesbetween the
successful and unsuccessful STCL fitting groups, mean changes in
visual/refractive outcomes between spectacles and fitted contact
lenses in both STCL fitting groups, and the mean CDVA change
produced in response to contact lens fitting for the STCL versus
the PB fitted eyes. Visual and refractive variables were compared
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Table 1
Patient data after ICRS implantation. Mean± SD.
Sphere (D) −2.18 ± 4.75
Cylinder (D) −3.11 ± 1.90
UDVA (logMAR) 0.74 ± 0.38
CDVA (logMAR) 0.25 ± 0.15
KM3 (D) 47.70 ± 4.65
Q45 −1.69 ± 1.45
UDVA: uncorrected distance visual acuity; CDVA: corrected distance visual acuity;
KM3: mean corneal power in the 3.00mm central zone; Q45: mean asphericity inthe4.5mmdiameter central corneal zone.
betweenspectacles andcontact lenses using theStudent’s t -testfor
paireddata. All statistical testswere performedusing Statgraphics
CenturionXVI software. Significancewas set at p
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Fig.1. LogMARCDVA(mean, SD)forspectaclesand each ofthe contact lensesfitted.
* A statistically significantdifference.
Fig. 2. Percentages of each type of contact lens finally fitted according to kerato-
conus stage prior to ICRS implantationsurgery.
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
fitted (Fig. 1). The mean logMAR CDVA increase produced after
contact lens fitting was 0.07±0.09logMAR in the STCL group
( p=0.003). Nodifferenceswere detected according to keratoconus
stage prior to surgery. In the eyes fitted with a PB system, the
mean logMAR CDVA increase was 0.23±0.16logMAR ( p=0.00),
again with no effects of prior keratoconus stage. Finally, the mean
increase produced in CDVA was 0.14±0.12logMAR in the SSCL
group. This variable was 1.15logMAR lines higher in the PB than
the STCL group ( p=0.003).
Fig. 2 shows the percentages of eyes finally fitted with each
contact lens type according to the keratoconus stage prior to ICRS
implantation: forstageI, 1 eye(8.33%) receiveda SSCL,9 (75%)eyesa 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 significant effects of 1 month’s wear of each
type of contact lens produced on corneal surface integrity and the
topographicmap.
4. Discussion
Only a few studies have addressed contact lens fitting in ICRS
implantedkeratoconic eyes, andmost have examined only a small
number of eyes [7,8,10,28]. Several studies have shown that cus-
tomized soft contact lenses [30,37,38] used to correct HOA in
aberrated eyes offer visual benefits over their use in normal eyes.
However, some authors [29,39]warn that the visual benefit for an
abnormal eyeismore sensitive todecentrationand rotationof cus-
tomized optics compared to normal eyes. In the present study, we
usednon-customized lathedsoftcontactlenses.Thelathe-cutelab-
orationmethodgives riseto a lenswithprecise,highlyreproducible
propertiesinducingminimalrotation, translationanddecentration
[20,29,40]. Further benefits of these soft contact lenses are an easy
manufacturing process thereby reducing costs, their easy access,
alongwith acceptable comfort and simplehandling for the patient.
When spectacle visual outcomes were compared in the suc-
cessfully and unsuccessfully STCL fitted groups, mean spectacle
CDVA was significantly better in the successful than the unsuc-
cessful group and mean corneal power in the central 3mm was
also lower in the successful group. Accordingly, eyes successfully
fittedwith a STCLweremoreoftenthoseatamoderatestageofker-
atoconus (Fig. 2) or those in which the surgery outcome had been
more satisfactory. The good STCL-CDVA observed in this group of
eyesmaybeattributed totheirbetterspectacleCDVAortoagreater
VA improvement produced after contact lens fitting.
The refractive powers of the fitted 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 posi-
tive power than spectaclepowerinmany cases, althoughtherewashigh variabilitybetweeneyes.A possibleexplanationfor this is that
the optical quality of the eye plus contact lens, besides depending
on the opticsof the eye,will alsodepends on the optical properties
of the lens and its interaction with the cornea and tear film (prob-
ably the power of the lacrimal lens is related to themodulus of the
contact lens andis possible tochange thefinalpowerwithdifferent
materials). Further influential factors include partial correction of
anterior corneal surface HOAby the soft contact lens, interactions
between low and high order aberrations at the two corneal sur-
faces, and finally rotation and translation effects. In our study, the
successfully STCL fitted group showed a flatter BC and in no case
was a BC of 8.00mmneeded for improved fitting. This could have
determined better interaction between the contact lens, tear film
and corneal surface.Ourresults indicate that thebetterCDVAwere 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 first
STCL fitted, althoughsphereandcylinder powerhadto bechanged.
This occurs more frequently in cases of a flatter cornea and lower
spectacle refraction. Thus, themean difference between the cylin-
deraxesof the spectacles andfinalSTCLfittedwasonly4.50±9.99◦
in the successfully STCL fittedgroup. In contrast, in the unsuccess-
fully STCL fitted group, although the refraction over the first STCL
fitted achieved a substantially better VA, the new calculated STCL
didnot show thesamegoodresult, especiallywhen therewas a sig-
nificant difference between the spectacle and STCL axes (Table 3).
Similarly,Nepomuceno et al. [28] describeda caseofa patientwith
Intacsfittedwith amoldedsoft toric contact lens. Spectacle refrac-tion was −1.25 sphere, −5.00 cylinder and VA was 0.12logMAR.
However, final contact lens power was −2.00 sphere,−1.25 cylin-
der, VA was −0.08logMAR and BC 8.70mm. In agreement with
our findings, STCL refractive power and the significantly improved
VAwere not those expected for soft contact lenses in eyes with a
regular cornea.
Results for our patients refitted with a piggy-back system
revealed this tobea goodoptionwhenSTCLfittingdid not achieve
a logMAR VA better than 0.2. In effect, this option mostly corre-
sponded to the eyes at themore advancedkeratoconus stageswith
greater HOA, inwhichsurgery hada reduced regularizingandflat-
tening effect. The mean increase in CDVA after PB fitting did not
varysignificantly fromthatobservedfor theSTCL, thoughoutcomes
werehighlyvariablebetweeneyes. It shouldbenoted thathandling
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