clinical study outcomes of a management strategy in eyes...

Clinical StudyOutcomes of a Management Strategy in Eyes withCorneal Irregularity and Cataract

Mathew Kurian Kummelil, Rohit Shetty, Luci Kaweri, Shama Shaligram,and Mukesh Paryani

Narayana Nethralaya Eye Hospital, 121/C Chord Road, Rajajinagar 1st R Block, Bangalore 560010, India

Correspondence should be addressed to Mathew Kurian Kummelil; [email protected]

Received 10 March 2016; Accepted 28 June 2016

Academic Editor: Germano Guerra

Copyright © 2016 Mathew Kurian Kummelil et al. This is an open access article distributed under the Creative CommonsAttribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work isproperly cited.

Purpose. To evaluate the outcomes of amanagement strategy in patientswith irregular corneas and cataract.Methods. Six eyes of fourpatients presented for cataract surgery with irregular corneas following corneal refractive surgery. Topoguided ablation regularisedthe cornea, followed by phacoemulsification and intraocular lens implantation. Zonal keratometric coefficient of variation (ZKCV)measured structural changes and visual qualitymetricsmeasured functional improvement.Results.Themean duration after cornealrefractive surgery was 7.83 ± 2.40 years. The logmar uncorrected distance visual acuity (0.67 ± 0.25) and the corrected distancevisual acuity (0.38 ± 0.20) improved to 0.34 ± 0.14 and 0.18 ± 0.10, respectively. The changes in the standard deviations of the zonalkeratometry values and the ZKCVwere statistically significant in the 2, 3, and 4mm zones.The changes in the Strehl ratio (ANOVA𝑝 = 0.043) were also statistically significant. Conclusions. Corneal regularisation followed by phacoemulsification resulted in lowerresidual refractive error with improved visual quality metrics.This strategy is a viable option in patients with symptomatic cataractsand irregular corneas.

1. Introduction

Since its birth 25 years ago, laser assisted in situ keratomileu-sis (LASIK) has been using excimer laser ablation to reshapethe cornea and correct refractive errors [1]. Those patientswho underwent LASIK in early days are now presentingwith age-related cataracts. Surgeries done in early yearswhen the nomogram was being revised had resulted infew cases of irregular corneas. Small or decentered opticalzones, irregular ablations, and central islands are associatedwith high corneal higher order aberrations (HOAs) [2, 3].Obtaining optimal optical outcomes with cataract surgeryin such cases is difficult. The dilemma of regularising thecornea first followed by cataract surgery or vice versa is alsounresolved.

Topography-guided customised ablation treatment (T-CAT) outcomes improve visual acuity and quality in irreg-ular corneas [4]. Refractive surgery complications, such aspost-LASIK ectasia, decentered ablation, and small optical

zones, have been successfully treated with this modality [5].We hereby describe a method of customising the cataractsurgeries in irregular corneas by doing a topoguided ablationto reduce corneal irregularity, assessing stability of keratom-etry and irregularity, followed by cataract surgery.

2. Methods

This was a prospective interventional case series adhering tothe tenets of the Declaration of Helsinki with institutionalethical board clearance. Patients presenting with symp-tomatic cataracts and history of laser in situ keratomileusis(LASIK) in the same eye and giving informed consent wereincluded. Exclusion criteria included preexisting ocular orchronic systemic disease, pregnant or nursing women, andone-eyed patients.

All patients underwent refraction, slit-lamp examina-tion, indirect ophthalmoscopy, and topography using the

Hindawi Publishing CorporationBioMed Research InternationalVolume 2016, Article ID 8497858, 8 pageshttp://dx.doi.org/10.1155/2016/8497858

2 BioMed Research International

6 eyes (plano target)12 months post-op

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BioMed Research International 3

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Figure 1: Standard refractive graphs showing (a) efficacy-uncorrected distance visual acuity (UDVA), (b) UDVA versus corrected distancevisual acuity (CDVA), (c) safety-change in CDVA, (d) attempted versus achieved spherical equivalent refraction, (e) accuracy of sphericalequivalent refraction, (f) amplitude of astigmatism, (g) stability of spherical equivalent refraction, (h) target induced astigmatism (TIA) versussurgically induced astigmatism (SIA), and (i) angle of error (C/wise stands for clockwise and CC/wise stands for counterclockwise).

Pentacam HR (Oculus Optikgerate GmbH). Axial lengthmeasurements were by immersion biometry when opticalbiometry was not possible.

Eyes with post-LASIK corneal irregularities, with noevidence of ectasia on Pentacam HR, and with minimalcorneal pachymetry of 400 microns underwent cornealregularisation using the topography-guided customised abla-tion treatment (T-CAT) software linked with the Alle-gretto Topolyzer system (WaveLight Laser Technologie AG,Germany). Adjunct corneal collagen cross-linking was notplanned for this study subset of patients as the predictedminimum pachymetry was more than 380 microns in allcases. An average of eight maps with at least 90% of thedata were taken by Allegretto Topolyzer system. The optical

zone diameter was restricted to 5.5–6.0mm after defining thetarget asphericity (𝑄-value) within a range of 0 to−0.6. Undertopical anaesthesia (proparacaine 0.5%; Alcon Inc., FortWorth, USA), the preexisting flap was raised and the plannedlaser ablation was performed, followed by balanced saltsolution irrigation of the residual stromal bed. Postoperativeregime was prednisolone acetate 1% eye drops (Pred Forte�prednisolone acetate ophthalmic suspension,Allergan, India)four times daily tapered weekly and moxifloxacin 0.5% eyedrops (Vigamox�, Alcon Inc., Fort Worth, USA) four timesdaily for one week with lubricating eye drops (Optive�,Allergan, India) four times daily.

The IOL power was calculated after achieving kerato-metric stability defined as change of 0.2 dioptres or less


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Figure 2: Equivalent 𝐾 reading (EKR) histogram to demonstrate the improved outcome following T-CAT. (a) EKR histogram of case 3 isshown preoperatively with broader base extending from 37D to 43D with two peaks. (b) Postoperatively, the EKR histogram shows a tallpeak with a narrow base extending from 37D to less than 40D. (c) The EKR histogram of case 6 is shown preoperatively with broader baseextending from 28.5D to 42D. (d) Postoperatively, the EKR histogram shows a narrow base from 32.5D to 36.5D with two peaks.

in standard deviation of mean 𝐾 over three consecutivevisits. The IOL power chosen for implantation was the min-imum IOL power obtained on American Society of Cataractand Refractive Surgery (ASCRS) post-LASIK calculator [6].Patients underwent phacoemulsification by a single surgeon(M. K. Kummelil) using a temporal clear corneal incision.

2.1. Assessments. Holladay’s equivalent keratometry reading(EKR) map on the Pentacam presents the mean equivalentkeratometry readings and their standard deviations in zonesaround the corneal apex. We derived the zonal keratometriccoefficient of variation (ZKCV) (dispersion of data pointsin a data series around the mean) from the zonal standarddeviation and the zonal mean keratometry as follows:

ZKCV= zonal keratometric standard deviation/zonalmean keratometry × 100

Efficacy assessments were the improvement in structural andfunctional parameters and safety was the percentage of eyeswith loss of two or more lines of CDVA [7].

2.2. Statistical Analysis. SPSS version 17 was used for statisti-cal analysis. The Shapiro-Wilk test checked normal distribu-tion of continuous variables. Comparisons between groupswere 2-sided to a significance of 0.05.

3. Results

This study included six eyes, three right and three left, offour patients, one male and three females, with a mean ageof 41.25 ± 9.95 years. The mean duration after LASIK was7.83 ± 2.40 years while the mean duration between T-CATand cataract surgery was 1.5 months.

The logmar uncorrected distance visual acuity (UDVA)at the time of presentation was 0.67 ± 0.25 (95% CI 0.404


Table 1: Mean ± standard deviation (95% confidence interval for mean) of the baseline variables, post-topoguided customised ablationtreatment (T-CAT), change from baseline, and 𝑝 values (paired sample tests).

Baselinemean ± std. deviation

(95% confidence intervalfor mean)

Post-T-CATmean ± std. deviation

(95% confidence intervalfor mean)

Change frombaseline

𝑝 value(paired

samples test)

1mmmean K 34.56 ± 4.08(30.28–38.84)

34.97 ± 2.94(31.88–38.06) 2.12 ± 2.50 0.844

2mmmean K 34.33 ± 3.62(30.53–38.13)

34.74 ± 2.85(31.75–37.72) 1.84 ± 2.27 0.834

3mmmean K 34.61 ± 3.23(31.23–38.00)

34.57 ± 2.73(31.71–37.43) 1.72 + 1.65 0.980

4mmmean K 34.97 ± 2.67(32.16–37.77)

34.55 ± 2.55(31.87–37.23) 1.40 ± 1.21 0.791

1mm Astig EKR65 0.93 ± 0.53(0.37–1.49)

0.47 ± 0.44(0.01–0.93) 0.55 ± 0.51 0.133

2mm Astig EKR65 1.40 ± 0.37(1.01–1.79)

0.62 ± 0.42(0.30–1.07) 0.82 ± 0.37 0.007

3mm Astig EKR65 1.41 ± 0.43(0.95–1.86)

0.59 ± 0.30(0.27–0.90) 0.82 ± 0.45 0.003

4mm Astig EKR65 1.48 ± 0.41(1.05–1.91)

0.67 ± 0.30(0.35–0.98) 0.81 ± 0.47 0.003

1mm SD 0.84 ± 0.44(0.38–1.30)

0.42 ± 0.14(0.27–0.57)

0.46 ± 0.44 0.051

2mm SD 1.28 ± 0.54(0.71–1.84)

0.71 ± 0.24(0.45–0.96) 0.58 ± 0.46 0.040

3mm SD 1.66 ± 0.76(0.86–2.46)

0.87 ± 0.29(0.57–1.17) 0.79 ± 0.62 0.038

4mm SD 2.03 ± 0.97(1.01–3.0)

0.99 ± 0.38(0.59–1.39) 1.04 ± 0.77 0.035

1mm CV 2.45 ± 1.24(1.14–3.75)

1.21 ± 0.40(0.79–1.63) 1.36 ± 1.27 0.042

2mm CV 3.84 ± 1.76(2.00–5.69)

2.06 ± 0.79(1.23–2.88) 1.81 ± 1.57 0.047

3mm CV 4.98 ± 2.58(2.28–7.68)

2.56 ± 1.03(1.48–3.64) 2.42 ± 2.16 0.058

4mm CV 5.99 ± 3.19(2.64–9.33)

2.94 ± 1.34(1.53–4.35) 3.05 ± 2.56 0.056

K: keratometry, EKR65: equivalent keratometry reading in 65% area, SD: standard deviation, and CV: coefficient of variance.

to 0.929) and following TPRK and cataract surgery showeda statistically significant improvement (Paired Samples Test𝑝 = 0.006) to 0.35 ± 0.14 (95% CI 0.205 to 0.495). Thecorrected distance visual acuity (CDVA) improvement from0.38 ± 0.20 (95% CI 0.169 to 0.598) to 0.18 ± 0.10 (95% CI0.080 to 0.287) was not statistically significant (WilcoxonSigned Ranks Test 𝑝 = 0.066). Standard refractive graphshave been shown in Figure 1.

The mean thinning in pachymetry after T-CAT was33 ± 16 microns at pupillary center, 36 ± 17 microns atapex, and 32 ± 17 microns at the thinnest corneal thicknesson Pentacam HR. Predicted Minimum pachymetry aftertreatment was 407 ± 16 microns with thinnest pachymetrybeing 380 microns. The RMS difference in the mean 𝐾showed a change of 2.12D in the 1mm zone and 1.40Din the 4mm zone. The mean reduction in the astigmatism(EKR 65% astigmatism) and the standard deviations of

the 𝐾 values were statistically significant from the 2mmto 4mm zone. The ZKCV showed a statistically significantreduction in the dispersion of measured keratometric datapoints around the mean keratometry for the 1 and 2mmzones (Table 1). The changes in the Strehl ratio (ANOVA𝑝 = 0.043) were statistically significant while the changein mean HOAs (Friedman test 𝑝 = 0.115) and area underthe curve of the MTF curve (ANOVA 𝑝 = 0.356) wasnot.

The mean IOL power used was 15.25 ± 3.52D. In fourof six (66%) eyes where the IOL power could be calculatedbefore and after T-CAT, the root mean square (RMS) changein theASCRS calculatorminimum IOLpowerwas 0.63D andin the maximum IOL power was 1.30D. The procedure was100% safe as none of the eyes had loss of two or more lines ofvision. Two of the six patients were within 0.5 dioptre sphere(DS) and four of the six patients were within 1DS.


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49.146.944.742.440.238.035.733.531.329.026.824.622.320.117.915.613.411.28.96.74.52.20.0Max: 53.59 𝜇m Cen: 50.46 𝜇m

51.849.747.545.343.241.038.936.734.532.430.228.125.923.721.619.417.315.113.010.88.66.54.32.20.0Max: 51.82 𝜇m Cen: 34.69 𝜇m

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Figure 3: Two eyes with irregular corneas after LASIK. (a) The patient’s cornea shows incomplete ablation with steep areas in thepupillary zone. (b) Intraoperative ablation profile used for treatment during topography-guided customised ablation treatment (T-CAT). (c)Postoperatively, there is flattening at the center of the cornea in the pupillary zone. (d)The patient’s cornea with decentered ablation showingboth flat and steep areas in the pupillary zone. (e) Intraoperative ablation profile used for treatment during T-CAT. (f) Postoperatively, thereis steepening at the center of the cornea in the pupillary zone.


4. Discussion

Patients with myopic LASIK present with cataracts early ascompared to general population [8]. Similar to the study doneby Iijima et al., our patients presented with cataract at anaverage age of 42 years. Incidence of post-LASIK cataractis low, almost 1 in 100 cases of normal cataracts [8]. It isnot common for patients who now present for cataract tohave irregular astigmatism as a result of prior LASIK surgeryand to the best of our knowledge no study has reported themanagement strategy in such cases.

Topographically irregular astigmatism has been classifiedas regularly irregular (asymmetric bow-tie or angled bow-tie or nonorthogonal astigmatism) and irregularly irregular(no recognizable pattern) [9]. Irregular astigmatism afterLASIK depends on the amount of surgery the eye received,the time since surgery, the size and centration of the opticalzone, and the occurrence of any intraoperative complications[10]. Irregularity is measured by assessing Zernike HOAsor Fourier irregularity. These tests do not give a measureof the variability of the keratometry. Therefore, a cataractsurgeon has to estimate the impact of the preexisting cornealirregularity on the mean keratometry values needed for IOLpower calculation. We describe a novel method of quan-tifying the corneal irregularity from the detailed HolladayReport by assessing the mean zonal keratometric coefficientof variation. As the mesopic pupillary diameter is 4mm, weused values up to 4mm zone for the analysis.

Because of its unique therapeutic benefits in treatment ofhighly irregular corneas, T-CAT was our treatment of choice[11]. All our patients showed improved regularity of corneaafter T-CAT as there was 45% in astigmatism, 52% reductionin standard deviation of 𝐾 values, and 51% reduction inZKCV till the 4mm zone and this improvement was reflectedin the improved EKR histogram (Figure 2).

Following stabilization of keratometry, cataract surgerywas performed with IOL implant power selected using theonline ASCRS calculator targeting emmetropia [6]. In eyeswith a central island, T-CAT would result in a relativelysteeper central cornea resulting in a myopic shift in IOLpower requirement and in eyes with decentered ablationsT-CAT would result in relative central flattening cornearesulting in a hyperopic shift in IOL power requirement(Figure 3).

Our study is limited by its small sample size and non-randomised comparison group. We also limited the durationafter T-CAT to an average of 6 weeks because of the need forearly visual rehabilitation. Possibility of corneal remodellingfor longer duration persists. In absence of standard guide-lines, wewaited for 3 consecutive follow-ups showing stabilityin terms of mean𝐾 fluctuation.

Conventionally, a secondary LASIK or surface ablationhas been the procedure of choice for postcataract refractivesurprises [12]. However, the alteration in the mean keratom-etry values by the T-CAT would induce an unpredictablemyopic or hyperopic shift in refraction depending on thenature of preexisting irregularity and treatment plan. Ourstrategy of treating the cornea by T-CAT first followed bycataract surgery is a safe and effective way of optimising

results in these cases. It is a relatively rare clinical situationand our case series documents the outcome and benefits of anovel sequence of performing the procedure.

Numbers are bound to increase with time as more ofthe baby boomers/early LASIK patients and those withcomplications will require cataract surgery. So we are puttingup the results for peer review and will expand the study to acase control/randomised control trial (RCT). If this strategyis seen to work in a RCT/case control trial then it can beconsidered as an option for the management of irregularastigmatism of all etiologies with coexisting cataract.

Competing Interests

Mathew Kurian Kummelil is on the advisory board of Alcon& Allergan and received research grants from Bioptigen &Zeiss. None of the other authors have any financial intereststo disclose.

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[12] J. L. Alio, A. A. Abdelghany, and R. Fernandez-Buenaga,“Enhancements after cataract surgery,” Current Opinion inOphthalmology, vol. 26, no. 1, pp. 50–55, 2015.

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