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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.

    http://localhost/var/www/apps/conversion/tmp/scratch_1/dx.doi.org/10.1016/j.clae.2014.06.001http://www.sciencedirect.com/science/journal/13670484http://www.elsevier.com/locate/claemailto:[email protected]:[email protected]://localhost/var/www/apps/conversion/tmp/scratch_1/dx.doi.org/10.1016/j.clae.2014.06.001http://localhost/var/www/apps/conversion/tmp/scratch_1/dx.doi.org/10.1016/j.clae.2014.06.001mailto:[email protected]:[email protected]://crossmark.crossref.org/dialog/?doi=10.1016/j.clae.2014.06.001&domain=pdfhttp://www.elsevier.com/locate/claehttp://www.sciencedirect.com/science/journal/13670484http://localhost/var/www/apps/conversion/tmp/scratch_1/dx.doi.org/10.1016/j.clae.2014.06.001

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    378  J. Carballo-Alvarez et al. / Contact Lens & Anterior Eye 37 (2014) 377–381

    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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     J. Carballo-Alvarez et al. / Contact Lens & Anterior Eye 37 (2014) 377–381 379

     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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    380  J. Carballo-Alvarez et al. / Contact Lens & Anterior Eye 37 (2014) 377–381

    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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