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ARTICLE
Toric intraocular len
s implantation versusastigmatic keratotomy to correct astigmatismduring phacoemulsificationJeewan S. Titiyal, MD, Mukesh Khatik, MD, Namrata Sharma, MD, Sri Vatsa Sehra, MD,
Parfulla K. Maharana, MD, Urmimala Ghatak, MD, Tushar Agarwal, MD, Sudarshan Khokhar, MD,Bhavana Chawla, MS
Q 2014 A
Published
SCRS an
by Elsev
PURPOSE: To compare toric intraocular lens (IOL) implantation and astigmatic keratotomy (AK) incorrection of astigmatism during phacoemulsification.
SETTING: Tertiary care hospital.
DESIGN: Prospective randomized trial.
METHODS: Consecutive patients with visually significant cataract and moderate astigmatism (1.25to 3.00 diopters [D]) were randomized into 2 groups. Temporal clear corneal 2.75 mm phacoemul-sification with toric IOL implantation was performed in the toric IOL group and with 30-degreecoupled AK at the 7.0 mm optic zone in the keratotomy group. The uncorrected (UDVA) andcorrected (CDVA) distance visual acuities, refraction, keratometry, topography, central cornealthickness, and endothelial cell density were evaluated preoperatively and 1 day, 1 week, and 1and 3 months postoperatively.
RESULTS: The study enrolled 34 eyes (34 patients), 17 in each group. There was no difference inUDVA or CDVA between the 2 groups at any follow-up visit. The mean preoperative andpostoperative refractive cylinder was 2.00 D G 0.49 (SD) and 0.33 G 0.17 D, respectively, inthe toric IOL group and 1.95 G 0.47 D and 0.57 G 0.41 D, respectively, in the keratotomygroup (PZ.10). The mean residual astigmatism at 3 months was 0.44 G 1.89 @ 160 in thetoric IOL group and 0.77 G 1.92 @ 174 in the keratotomy group (PZ.61). All eyes in the toricIOL group and 14 eyes (84%) in the keratotomy group achieved a residual refractive cylinder of1.00 D or less (PZ.17).
CONCLUSION: Toric IOL implantation was comparable to AK in eyes with moderate astigmatismhaving phacoemulsification.
Financial Disclosure: No author has a financial or proprietary interest in any material or methodmentioned.
J Cataract Refract Surg 2014; -:-–- Q 2014 ASCRS and ESCRS
There has been a paradigm shift in patient and surgeonexpectations of cataract surgery. The procedure is nolonger just a means to restore visual acuity but isalso a way to achieve emmetropia in many cases.However, a significant obstacle is astigmatism, with15% to 56% of eyes having greater than 1.00 diopter(D) of astigmatism after phacoemulsification.1 Astig-matism produces glare, monocular diplopia, astheno-pia, and visual distortion. Preexisting astigmatismduring cataract surgery may be corrected by modi-fying the incision,1,2 creating limbal relaxing incisions
d ESCRS
ier Inc.
(LRIs),1,3 performing astigmatic keratotomy (AK),1,3–8
and, more recently, implanting a toric intraocular lens(IOL).9–19
Astigmatic keratotomy and toric IOL implantationare important procedures to correct moderate to se-vere astigmatism. Although several studies haveevaluated these separately, a comparative evaluationhas not been reported. In this study, we comparedthe results of toric IOL implantation with those ofAK in patients with moderate regular astigmatismwho had phacoemulsification.
0886-3350/$ - see front matter 1http://dx.doi.org/10.1016/j.jcrs.2013.10.036
2 TORIC IOL VERSUS ASTIGMATIC KERATOTOMY FOR ASTIGMATISM CORRECTION
PATIENTS AND METHODS
This prospective randomized clinical trial was approved bythe institutional review board at the tertiary care referral cen-ter. The tenets of the Declaration of Helsinki were followed.
Consecutive patients from 45 to 65 years old who pre-sented to the outpatient department or anterior segment ser-vices of the center with visually significant immature senilecataract, regular bow-tie moderate corneal astigmatism(1.25 to 3.0 D), and no ocular or systemic contraindicationsto surgery were included. Patients with complicated cata-ract, posterior segment pathology, astigmatism less than1.25 D or greater than 3.00 D, or a systemic condition likelyto result in an unpredictable response to surgery (eg,collagen vascular disease, diabetes mellitus) were excluded.Also excluded were patients who expressed an inability toattend follow-up visits or who were not willing to providewritten consent.
Patients who met the inclusion criteria were recruited andrandomized into 2 groups with an equal number of eyes.Randomization was performed using a table of randomnumbers.
All patients had clear corneal temporal phacoemulsifica-tion surgery. This was followed by implantation of a foldabletoric IOL (Acrysof IQ Toric, Alcon Surgical, Inc.) in the toricIOL group and by AK with implantation of a foldableaspheric IOL (Acrysof IQ, Alcon Surgical, Inc.) in the keratot-omy group.
Preoperatively, patients had an extensive ophthalmologicevaluation including uncorrected distance visual activity(UDVA), corrected distance visual acuity (CDVA), cyclo-plegic refraction with homatropine 2.0%, slitlamp bio-microscopy, clinical photography, videokeratography (Atlas9000, Carl Zeiss Meditec AG), scanning-slit topography(Orbscan II, Bausch & Lomb), noncontact specularmicroscopy (Topcon SP 3000 P), manual keratometry(Bausch & Lomb), and ultrasound pachymetry (MicropachModel 200PC, Sonomed, Inc.) to measure central cornealthickness (CCT).
Surgical Technique
Phacoemulsification surgery was performed using topicalanesthesia (proparacaine hydrochloride 0.5%). The samesurgeon (J.S.T.) performed all surgeries.
In the toric IOL group, a preoperative reference mark wasplaced with a marking pen at the 6 o’clock limbus and at3 o’clock and 9 o’clock under slitlamp biomicroscopy. Thefinal orientation of the steepmeridianwas confirmed againstthis marking on the operating table using an axis-markingdial on the table. A self-sealing temporal clear corneal inci-sion was created with a 2.75 mm keratome, and
Submitted: April 2, 2013.Final revision submitted: October 3, 2013.Accepted: October 9, 2013.
From Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All IndiaInstitute of Medical Sciences, New Delhi, India.
Corresponding author: Namrata Sharma, MD, Cornea and Refrac-tive Surgery Services, Dr. Rajendra Prasad Centre for OphthalmicSciences, All India Institute of Medical Sciences, Ansari Nagar,New Delhi–110026, India. E-mail: [email protected].
J CATARACT REFRACT SURG
phacoemulsificationwas performed. The IOLwas implantedin the capsular bag using a Monarch II injector with a C-car-tridge (Alcon Laboratories, Inc.). Initially, the IOL wasrotated into a position that was approximately 15 degreesshort of the actual marked axis of placement. The residualophthalmic viscosurgical device was removed from behindthe IOL and from the anterior chamber. Subsequently, theIOL was rotated to align the peripheral dots on it with themarked steep meridian on the cornea. The anterior chamberwas reformed, and stromal hydration of the main incisionsand paracentesis was performed. Correct alignment of theIOL was again verified at the end of surgery. All incisionswere hydrated and left sutureless after they were checkedfor leakage.
In the keratotomy group, preoperative reference markswere placed at 6 o’clock, 3 o’clock, and 9 o’clock at the limbusunder slitlamp biomicroscopy, as in the toric IOL group.Astigmatic keratotomy was performed before phacoemulsi-fication.20 The center of the cornea and a 7.0 mm optical zonewere marked. A 12-blade radial keratotomy marker wasplaced on the 7.0 mm optical zone mark. Paired arcuate ker-atotomy incisions weremade in the 7.0mm optical zone. The30-degree pairedAK cutsweremade on the steepermeridianusing a micrometer-guided diamond knife (Meyco) that wasset at 100% of the thinnest paracentral pachymetry. Next, a2.75 mm clear corneal temporal incision was created, phaco-emulsification was performed, and a foldable IOL was im-planted. The wound was hydrated at the end of surgeryand left sutureless after it was checked for leakage.
Postoperatively, patients were advised to avoid trauma totheir operated eye. They were prescribed topical moxifloxa-cin hydrochloride 0.5% 4 times a day for 4 weeks; predniso-lone acetate 1.0% 4 times a day for 4weeks, after which it wastapered; and tropicamide 1.0% 2 times a day for 3 weeks.
Outcome Measures
Patients were examined 1 day, 1week, and 1 and 3monthsafter surgery. The UDVA and CDVA were assessed using astandard wall-mounted Snellen chart. Slitlamp bio-microscopy was performed to assess the anterior segment.Corneal topography was evaluated using videokeratogra-phy and scanning-slit topography. The endothelial cell den-sity (ECD) was calculated using noncontact specularmicroscopy. Subjective refraction and manual keratometrywere performed, and the residual astigmatism (vectoranalysis using the postoperative subjective refraction) wascalculated. The toric IOL axis was determined under mydri-asis using the degree scale on the vertical arm of the slitlamp.Photographs were taken at each follow-up to compare theslitlamp axis estimates with those obtained using AdobePhotoshop CS2 image-editing software (version 9.0.2, AdobeSystems, Inc.).21
Statistical Analysis
Statistical analysis was performed using SPSS for Win-dows software (version 16.0, SPSS, Inc.). The sample sizewas calculated as a minimum of 15 eyes in each group toattain a power of 0.8 and an a of 0.05. Visual acuity was con-verted from Snellen fraction notation to the logMAR scale foranalysis. For description, quantitative variables were ex-pressed as the mean G standard deviation and qualitativevariables as a percentage. The chi-square test was used forcategorical variables. The Mann-Whitney and Wilcoxonsigned-rank tests were used for quantitative variables.
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Table 1. Comparison of baseline parameters between the toric IOL group and the keratotomy group.
Parameter
Mean G SD
P Value*Toric IOL Group (n Z 17) Keratotomy Group (n Z 17)
Age (y) 60.70 G 5.99 62.23 G 3.29 .28UDVA (logMAR) 0.85 G 0.36 1.15 G 0.51 .07CDVA (logMAR) 0.22 G 0.06 0.23 G 0.66 .41Refractive astigmatism (D) 2.00 G 0.49 1.95 G 0.47 .77Corneal astigmatism† (D) 2.02 G 0.53 2.18 G 0.59 .31ECD (cells/mm2) 2570.2 G 262.4 2565.5 G 250.2 .91
CDVA Z corrected distance visual acuity; ECD Z endothelial cell density; IOL Z intraocular lens; UDVA Z uncorrected distance visual acuity*t test†Manual keratometry
3TORIC IOL VERSUS ASTIGMATIC KERATOTOMY FOR ASTIGMATISM CORRECTION
Comparison between groups was performed using indepen-dent t tests. A P value less than 0.05 was considered statisti-cally significant.
RESULTS
The study enrolled 34 eyes of 34 patients; each of the2 groups comprised 17 eyes. There were no dropoutsin either group, and all patients were followed regu-larly for a minimum of 3 months. Table 1 comparesthe baseline parameters between the toric IOL groupand the keratotomy group; the groups were compara-ble in all parameters.
Visual Acuity
Postoperatively, vision improved in both groups(Figure 1). There was no statistically significant differ-ence in UDVA or CDVA between the groups at anytime during the follow-up. After 3 months, the meanUDVAwas 0.15G 0.01 logMAR in the toric IOL groupand 0.21 G 0.11 logMAR in the keratotomy group
Figure 1. Uncorrected distance visual acuity (UDVA) over thefollow-up. The length of the vertical line depicts the standard devi-ation (IOL Z intraocular lens).
J CATARACT REFRACT SURG
(PZ.24). The CDVA was 0.00 logMAR in all patientsin both groups at the 3-month follow-up (PZ.99).
Refraction
Refractive astigmatism decreased in both groups.There was no statistically significant difference be-tween the 2 groups at any follow-up (Table 2). Alleyes in the toric IOL group and 14 eyes (84%) inthe keratotomy group had residual astigmatism of1.00 D or less. Three eyes in the keratotomy grouphad residual astigmatism of 1.50 D or less (PZ.17)(Figure 2).
Keratometry
There was a postoperative reduction in cornealastigmatism in the keratotomy group but no signifi-cant change in the toric IOL group (Table 2).
Residual Astigmatism
Vector analysis of subjective refraction showed thatat 3 months, the residual astigmatism was 0.44G 1.89@ 160 and 0.77G 1.92 @ 174 in the toric IOL group andkeratotomy group, respectively (PZ.61). There was nostatistically significant difference between the groupsat any follow-up (Table 3).
Specular Microscopy
Both groups had a statistically significant reductionin ECD after surgery, which was evident at 1 day offollow-up (both PZ.01). Endothelial cell density didnot change significantly after that time. By the end of3 months, the mean percentage decrease was 1.7% inthe toric IOL group and 3.0% in the keratotomy group.There was no statistically significant difference be-tween the groups at any follow-up.
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Table 2. Change in astigmatism over time by group.
Astigmatism
Mean (D) G SD
Preoperative
Postoperative
1 Day P Value* 1 Week
Refractive: arithmetic meanToric IOL 2.00 G 0.49 0.47 G 0.23 .00 0.39 G 0.23Keratotomy 1.95 G 0.47 0.66 G 0.49 .00 0.58 G 0.43P value† .77 .32 .31
Refractive: vector meanz
Toric IOL 0.36 G 2.06 @ 140 0.28 G 0.46 @ 12 .04 0.27 G 0.44 @ 10Keratotomy 0.58 G 1.66 @ 166 0.26 G 0.84 @ 172 .02 0.26 G 0.80 @ 170P value† .73 .93 .96
Corneal: arithmetic meanToric IOL 2.02 G 0.53 1.63 G 0.53 .10 1.64 G 0.55Keratotomy 2.18 G 0.59 1.00 G 0.48 .00 1.06 G 0.52P value† .31 .00 .03
IOL Z intraocular lens*Wilcoxon matched-pairs test for comparison within a group†Mann-Whitney test for comparison between groupszMean diopters G SD @ degrees
4 TORIC IOL VERSUS ASTIGMATIC KERATOTOMY FOR ASTIGMATISM CORRECTION
Complications
The IOL alignment in the toric IOL group waswithin the acceptable range. The mean misalignmentwas 4.8 G 1.2 degrees. No IOL was misaligned morethan 10 degrees. Potential complications of AK, suchas corneal ectasia or a hyperopic shift, were not seenin any eye. Therewas no statistically significant regres-sion of the astigmatic correction in either grouppostoperatively.
DISCUSSION
Astigmatism in eyes having cataract surgery can bemanaged by surgical methods including LRIs, AK,and toric IOL implantation. Astigmatic keratotomyhas been extensively studied as a means to reducecorneal astigmatism; guidelines for this procedure
Figure 2. Postoperative residual refractive astigmatism(IOL Z intraocular lens).
J CATARACT REFRACT SURG
were formulated by the Prospective Evaluation ofAstigmatic Keratotomy Study and the AstigmatismReduction Clinical Trials (ARC-T) group.22–24 Astig-matic keratotomy has shown good results in reducingastigmatism in patients having cataract surgery.24,25
Toric IOL implantation is a newer modality for thecorrection of astigmatism in patients having cataractsurgery. Since the first report by Shimizu et al. in1994,9 several studies6,11–13,15–19,26–31 have evaluatedresults of toric IOL implantation in these patients.Poll et al.32 compared toric IOL implantation with pe-ripheral corneal relaxing incisions in 2011. They foundthat the 2 modalities were comparable in cases of mildtomoderate astigmatism, while toric IOL implantationmay be a better option in eyes with a higher degree ofastigmatism.
To our knowledge, no previous study compared theoutcomes of toric IOL implantation with those of AKin patients having phacoemulsification. In our study,the 2 procedures gave comparable results. At allfollow-up visits, the visual acuity and mean astigma-tism were comparable in the toric IOL group and theAK group. The corneal cylinder was higher than therefractive cylinder in the AK group at the 6-monthfollow-up. This may be different at 1 year becausethe AK incisions take time to heal. A subanalysis ofthese cases by separating them into groups of with-the-rule astigmatism and against-the-rule astigmatismwas attempted but did not yield meaningful resultsdue to the small numbers. We did not makeadjustments to the nomogram, and this may havecontributed to less than optimum results. Also, there
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Mean (D) G SD
Postoperative
P Value* 1 Month P Value* 3 Months P Value*
.31 0.35 G 0.17 .56 0.33 G 0.17 .73
.61 0.57 G 0.45 .94 0.57 G 0.41 1.00.17 .10
.94 0.27 G 0.43 @ 8 1.00 0.28 G 0.43 @ 8 .921.00 0.25 G 0.79 @ 170 .94 0.24 G 0.78 @ 170 .98
.92 .88
.95 1.64 G 0.65 1.00 1.64 G 0.54 1.00
.72 1.02 G 0.50 .82 0.99 G 0.54 .86.01 .00
Table 2. (Cont.)
5TORIC IOL VERSUS ASTIGMATIC KERATOTOMY FOR ASTIGMATISM CORRECTION
may be an element of posterior corneal astigmatism;this has been reported recently33 and may decreasethe accuracy of the procedure; we did not take thisinto account. No regression of astigmatic correctionwas noted in either group.
Toric IOL implantation has inherent advantagesover AK. It is less surgically demanding and doesnot require the use of special instruments; it alsodoes not increase the duration of the phacoemulsifica-tion surgery. Furthermore, there are reports of micro-bial keratitis,34 endophthalmitis,34 cystoid macularedema,35 retinal detachment,36 and epithelialingrowth after AK.37 Although there were no casesof regression of astigmatic correction after AK in ourstudy, results may be unpredictable, as reported bythe ARC-T study group.38 The possibility of cornealectasia after AK should also be kept in mind, in partic-ular in patients with thin corneas.39
Table 3. Residual astigmatism by group.
Postop Exam
Mean Residual Astigmatism (D) G SD
P Value*Toric IOL Keratotomy
1 day 0.41 G 1.90 0.77 G 1.96 .591 week 0.42 G 1.90 0.77 G 1.93 .591 month 0.44 G 1.89 0.78 G 1.93 .603 months 0.44 G 1.89 0.77 G 1.92 .61
IOL Z intraocular lens*Mann-Whitney test
J CATARACT REFRACT SURG
Apossible concernwith toric IOL implantation is rota-tional stability19,29; however, in our study, toric IOLalignment was maintained within 10 degrees of the in-tended axis and no IOL required surgical repositioning.Another drawback is the additional cost of toric IOLs.
To conclude, in our study, both proceduresdcata-ract surgery with toric IOL implantation and cataractsurgery with AKdwere comparable in terms of post-operative astigmatism and visual acuity in eyes withmoderate astigmatism. Either procedure may beused to correct astigmatism in this range.
-
WHAT WAS KNOWN
� Toric IOL implantation and AK are effective procedures totreat astigmatism during cataract surgery. Although toricIOLs are expensive, AK is a specialized procedure that re-quires additional surgical skills.
� Although the techniques have been studied individually, itis not known how they compare with each other andwhich procedure should be preferred.
WHAT THIS PAPER ADDS
� Toric IOL implantation and AK gave comparable visual andastigmatic results.
� The results indicate that either procedure can be used totreat astigmatism during cataract surgery. The choice ofprocedure can be made based on patient and surgeonpreference.
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6 TORIC IOL VERSUS ASTIGMATIC KERATOTOMY FOR ASTIGMATISM CORRECTION
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