Clear Lens Extraction with Multifocal Apodized Diffractive Intraocular Lens Implantation

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Clear Lens Extraction with Multifocal Apodized Diffractive Intraocular Lens Implantation Luis Fernández-Vega, MD, PhD, 1,2 José F. Alfonso, MD, PhD, 1,2 Pedro P. Rodríguez, MD, PhD, 1 Robert Montés-Micó, PhD 3 Purpose: To assess efficacy, safety, predictability, and stability after clear lens extraction (CLE) with multifocal diffractive intraocular lens (IOL) implantation. Design: Prospective, nonrandomized, masked observational case series (self-controlled). Participants: Two hundred twenty-four eyes of 112 consecutive patients after CLE with bilateral AcrySof ReSTOR Natural IOL implantation. Eyes were divided into myopic (mean spherical equivalent [SE], 6.012.71 diopters [D]) and hyperopic (mean SE, 3.862.52 D) groups. Methods: Monocular and binocular uncorrected distance visual acuity (VA), best-corrected distance VA, uncorrected distance near VA, and best distance-corrected near VA were recorded preoperatively and 6 months after surgery. Main Outcomes Measures: Efficacy, safety, predictability, and stability. Results: At 6 months postoperatively, uncorrected distance VA was 20/25 or better in 100% of the eyes. Efficacy indexes were 0.97 for myopic and 0.96 for hyperopic patients. No eye lost 2 lines of best-corrected distance VA; for the myopic group, 10 eyes gained 1 line, and 10 eyes gained 2 lines; for the hyperopic group, 20 eyes gained 1 line, and 15 eyes gained 2 lines. Safety indexes were 1.05 for myopic and 1.02 for hyperopic patients. All eyes were within 1.00 D of the desired refraction. No eye lost 2 lines of best distance-corrected near VA; for the myopic group, 10 eyes lost 1 or 2 lines, 15 eyes gained 1 line, and 5 eyes gained 2 lines; for the hyperopic group, 8 eyes lost 1 or 2 lines, 20 eyes gained 1 line, and 16 eyes gained 2 lines. Safety indexes at near were 1.05 for myopic and 1.11 for hyperopic patients. Uncorrected distance near VA was better for hyperopic than myopic patients (0.950.08 vs. 0.880.15). Efficacy indexes at near were 1.03 for myopic and 1.10 for hyperopic patients. Conclusions: Clear lens extraction with multifocal IOL implantation is an effective procedure for correcting ametropia and presbyopia. Safety and efficacy indexes at distance were comparable in myopic and hyperopic patients. However, at near, both indexes were larger for hyperopic patients. Ophthalmology 2007;114: 1491–1498 © 2007 by the American Academy of Ophthalmology. Removal of the clear crystalline lens and replacement with a multifocal or accommodating intraocular lens (IOL) for the purpose of reducing or eliminating refractive errors and presbyopia has been considered as a new refractive surgery modality. Combination of clear lens extraction (CLE) with multifocal or accommodating IOL could address myopic and hyperopic refractive errors, including presbyopia, while eliminating the need for cataract surgery in the future. Only 2 previous studies 1,2 showed that CLE with multi- focal IOL implantation is a safe and effective refractive surgery modality. Packer et al 1 reported excellent visual results in a small sample of 68 eyes implanted with the Array multifocal IOL (AMO, Santa Ana, CA). Dick et al 2 also concluded that CLE with Array multifocal IOL implan- tation in 24 myopic and 26 hyperopic eyes was safe, effec- tive, and predictable in correcting ametropia and presbyo- pia. As Dick et al 2 pointed out, the increasing interest in refractive surgery as well as the relative simplicity and efficacy of this surgical technique explain the continuing popularity of CLE. New generations of multifocal IOLs have been developed to achieve better visual outcomes than those obtained with older designs. Then, it becomes inter- esting to assess the CLE technique with implantation of new multifocal IOLs in a large population. One of the more popular current multifocal IOLs is the AcrySof ReSTOR IOL (Alcon, Fort Worth, TX). However, no studies have been performed to assess this technique followed by im- plantation of the AcrySof ReSTOR multifocal IOL. Originally received: August 26, 2006. Accepted: October 26, 2006. Manuscript no. 2006-939. 1 Fernández-Vega Ophthalmological Institute, Oviedo, Spain. 2 Surgery Department, School of Medicine, University of Oviedo, Spain. 3 Optics Department, Faculty of Physics, University of Valencia, Spain. The authors have no proprietary interest in any of the materials mentioned in the article. Correspondence to José F. Alfonso, MD, PhD, Instituto Oftalmológico Fernández-Vega, Avda. Dres. Fernández-Vega 34, 33012 (Oviedo), Spain. E-mail: [email protected]. 1491 © 2007 by the American Academy of Ophthalmology ISSN 0161-6420/07/$–see front matter Published by Elsevier Inc. doi:10.1016/j.ophtha.2006.10.058

Transcript of Clear Lens Extraction with Multifocal Apodized Diffractive Intraocular Lens Implantation

Clear Lens Extraction with MultifocalApodized Diffractive IntraocularLens Implantation

Luis Fernández-Vega, MD, PhD,1,2 José F. Alfonso, MD, PhD,1,2 Pedro P. Rodríguez, MD, PhD,1

Robert Montés-Micó, PhD3

Purpose: To assess efficacy, safety, predictability, and stability after clear lens extraction (CLE) withmultifocal diffractive intraocular lens (IOL) implantation.

Design: Prospective, nonrandomized, masked observational case series (self-controlled).Participants: Two hundred twenty-four eyes of 112 consecutive patients after CLE with bilateral AcrySof

ReSTOR Natural IOL implantation. Eyes were divided into myopic (mean spherical equivalent [SE], �6.01�2.71diopters [D]) and hyperopic (mean SE, �3.86�2.52 D) groups.

Methods: Monocular and binocular uncorrected distance visual acuity (VA), best-corrected distance VA,uncorrected distance near VA, and best distance-corrected near VA were recorded preoperatively and 6 monthsafter surgery.

Main Outcomes Measures: Efficacy, safety, predictability, and stability.Results: At 6 months postoperatively, uncorrected distance VA was 20/25 or better in 100% of the eyes.

Efficacy indexes were 0.97 for myopic and 0.96 for hyperopic patients. No eye lost �2 lines of best-correcteddistance VA; for the myopic group, 10 eyes gained 1 line, and 10 eyes gained �2 lines; for the hyperopic group,20 eyes gained 1 line, and 15 eyes gained �2 lines. Safety indexes were 1.05 for myopic and 1.02 for hyperopicpatients. All eyes were within �1.00 D of the desired refraction. No eye lost �2 lines of best distance-correctednear VA; for the myopic group, 10 eyes lost 1 or 2 lines, 15 eyes gained 1 line, and 5 eyes gained 2 lines; for thehyperopic group, 8 eyes lost 1 or 2 lines, 20 eyes gained 1 line, and 16 eyes gained 2 lines. Safety indexes at nearwere 1.05 for myopic and 1.11 for hyperopic patients. Uncorrected distance near VA was better for hyperopicthan myopic patients (0.95�0.08 vs. 0.88�0.15). Efficacy indexes at near were 1.03 for myopic and 1.10 forhyperopic patients.

Conclusions: Clear lens extraction with multifocal IOL implantation is an effective procedure for correctingametropia and presbyopia. Safety and efficacy indexes at distance were comparable in myopic and hyperopicpatients. However, at near, both indexes were larger for hyperopic patients. Ophthalmology 2007;114:

1491–1498 © 2007 by the American Academy of Ophthalmology.

Removal of the clear crystalline lens and replacement witha multifocal or accommodating intraocular lens (IOL) forthe purpose of reducing or eliminating refractive errors andpresbyopia has been considered as a new refractive surgerymodality. Combination of clear lens extraction (CLE) withmultifocal or accommodating IOL could address myopicand hyperopic refractive errors, including presbyopia, whileeliminating the need for cataract surgery in the future.

Originally received: August 26, 2006.Accepted: October 26, 2006. Manuscript no. 2006-939.1 Fernández-Vega Ophthalmological Institute, Oviedo, Spain.2 Surgery Department, School of Medicine, University of Oviedo, Spain.3 Optics Department, Faculty of Physics, University of Valencia, Spain.

The authors have no proprietary interest in any of the materials mentionedin the article.

Correspondence to José F. Alfonso, MD, PhD, Instituto OftalmológicoFernández-Vega, Avda. Dres. Fernández-Vega 34, 33012 (Oviedo), Spain.

E-mail: [email protected].

© 2007 by the American Academy of OphthalmologyPublished by Elsevier Inc.

Only 2 previous studies1,2 showed that CLE with multi-focal IOL implantation is a safe and effective refractivesurgery modality. Packer et al1 reported excellent visualresults in a small sample of 68 eyes implanted with theArray multifocal IOL (AMO, Santa Ana, CA). Dick et al2

also concluded that CLE with Array multifocal IOL implan-tation in 24 myopic and 26 hyperopic eyes was safe, effec-tive, and predictable in correcting ametropia and presbyo-pia. As Dick et al2 pointed out, the increasing interest inrefractive surgery as well as the relative simplicity andefficacy of this surgical technique explain the continuingpopularity of CLE. New generations of multifocal IOLshave been developed to achieve better visual outcomes thanthose obtained with older designs. Then, it becomes inter-esting to assess the CLE technique with implantation of newmultifocal IOLs in a large population. One of the morepopular current multifocal IOLs is the AcrySof ReSTORIOL (Alcon, Fort Worth, TX). However, no studies havebeen performed to assess this technique followed by im-

plantation of the AcrySof ReSTOR multifocal IOL.

1491ISSN 0161-6420/07/$–see front matterdoi:10.1016/j.ophtha.2006.10.058

Ophthalmology Volume 114, Number 8, August 2007

The purpose of this study was to assess efficacy, safety,predictability, and stability in patients who had undergonebilateral implantation of the AcrySof ReSTOR IOL in thecapsular bag after CLE.

Patients and Methods

Study Design

We prospectively examined 224 eyes of 112 consecutive patientswho underwent bilateral implantation of the AcrySof ReSTORmultifocal IOL at the Fernández-Vega Ophthalmological Institute,Oviedo, Spain, between August 2004 and November 2005.

Inclusion criteria were age between 45 and 70 years and motiva-tion: the desire no longer to wear any form of spectacle or contact lenscorrection for distance and near vision. The exclusion criteria includedcataract, best-corrected distance visual acuity (VA) � 20/25 in eithereye, preoperative astigmatism � 1.50 diopters (D), history of glau-coma or retinal detachment (RD), corneal disease, previous cor-neal or intraocular surgery, abnormal iris, pupil deformation, mac-ular degeneration or retinopathy, neuro-ophthalmic diseases, andhistory of ocular inflammation.

Before the CLE procedure, patients had a complete ophthal-mologic examination, including manifest and cycloplegic re-fraction, keratometry, slit-lamp biomicroscopy, Goldmann ap-planation tonometry, and binocular indirect ophthalmoscopythrough dilated pupils. Axial length and anterior segment sizewere measured with the Zeiss Humphrey IOL Master biometer(Carl Zeiss Meditec, Inc., Dublin, CA). The SRK/T formula wasused in myopic patients. The Holladay II formula was used for IOLpower calculation in hyperopic patients. The targeted refractionwas emmetropia.

All surgeries in this study were operated by phacoemulsifica-tion with the Infiniti Vision System (Alcon, Fort Worth, TX) usingtopical anesthesia and a clear corneal 2.8- to 3.2-mm incision by 2experienced surgeons (JFA, LF-V). Phacoemulsification was fol-lowed by irrigation and aspiration of the cortex and IOL implan-tation in the capsular bag. Clear lens extraction was performed inboth eyes within 2 weeks. There were no complications in any ofthe case. The tenets of the Declaration of Helsinki were followedin this research. Informed consent was obtained from all patientsafter the nature and possible consequences of the study wereexplained. Institutional review board approval was obtained.

The AcrySof ReSTOR Natural multifocal IOL combined thefunctions of both apodized diffractive and refractive regions. Theapodized diffractive optics are found within the central 3.6-mmoptic zone of the IOL. This area comprises 12 concentric steps ofgradually decreasing (1.3–0.2 �m) step heights creating a multi-focality from near to distant (2 foci). The refractive region of theoptic surrounds the apodized diffractive region. This area directslight to a distance focal point for larger pupil diameter and isdedicated to distance vision. The overall diameter of the lens is13.0 mm, and the optical diameter is 6.0 mm. Lens power variedfrom �10.0 D to �30.0 D, incorporating a �4.0-D near additionpower.

Monocular and binocular uncorrected distance VA, best-corrected distance VA, uncorrected near VA, and best distance-corrected near VA were recorded preoperatively and postopera-tively at 6 m and 33 cm, respectively, in all patients. Postoperativeassessments were performed routinely at 1 week and 1, 3, and 6

months after surgery. All patients completed 6-month follow-up.

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Data Analysis

All examinations were performed at 6 months after implantationby one ophthalmic technician who was unaware of the objective ofthe study. Data analysis was performed using SPSS for Windowsversion 12.0 (SPSS Inc., Chicago, IL). Normality was checked bythe Shapiro–Wilk test, and the t test was performed to comparepresurgery and postsurgery outcomes. Differences were consid-ered to be statistically significant when the P value was �0.01(i.e., at the 1% level).

Results

One hundred twelve patients were enrolled in this study. Patientdemographics are shown in Table 1. A total of 224 eyes received anAcrySof ReSTOR Natural multifocal IOL. Eyes were divided intogroups: myopic (n � 66, spherical equivalent [SE] � �0.50 D),myopia with an average preoperative SE refraction of �6.01�2.71 D,and hyperopic (n � 158, SE � �0.50 D), hyperopia with anaverage preoperative SE refraction of �3.86�2.52 D. Mean pa-tient age was 52.2�5.7 years (range, 45–70). Mean axial lengthwas 23.23�1.91 mm (range, 20.31–28.98).

Safety

In the myopic group, 6 months after surgery none of the examinedeyes had lost �2 lines of best-corrected distance VA (Fig 1). Foureyes lost 1 line, 42 eyes did not change after surgery, 10 eyesgained 1 line, 7 eyes gained 2 lines, and 3 eyes gained �2 lines ofVA. The safety index (ratio of postoperative and preoperativebest-corrected distance VAs) at 6 months was 1.05. For the hy-peropic group, 17 eyes lost 1 line, 106 eyes had unchangedbest-corrected distance VA after surgery, 20 eyes gained 1 line, 11eyes gained 2 lines, and 4 eyes gained �2 lines of VA. The safetyindex at 6 months was 1.02.

Efficacy

In the myopic group, uncorrected distance VA (Snellen decimalVA) improved in 100% of the patients (Fig 2). Six months post-

Table 1. Demographic Characteristics of Participants

Myopic Group Hyperopic Group

No. of eyes 66 158Mean age (yrs) � SD 51.4�4.5 52.6�6.1Range of age (yrs) 45–70 45–70Gender (male/female) 11/22 27/52Mean IOL power (D) � SD 14.0�3.1 25.4�3.3Mean preoperative sphere (D) � SD �5.56�2.82 3.54�2.49Range of preoperative sphere (D) �0.75 to �11 0.75–8.50Mean preoperative cylinder

(D) � SD�0.90�0.77 �0.64�0.89

Range of preoperative cylinder (D) 0–1.50 0–1.50Mean preoperative keratometry (K)

(D) � SDK1 43.81�1.47 42.93�1.75K2 44.61�1.58 43.75�1.51

Range of preoperative keratometry(D)

40.75–48.25 38.50–48.00

Mean axial length (mm) � SD 25.55�1.28 22.15�0.91Range of axial length (mm) 23.34–28.98 20.31–24.89

D � diopters; IOL � intraocular lens; SD � standard deviation.

Fernández-Vega et al � Multifocal Apodized Diffractive IOL after Clear Lens Extraction

operatively, mean uncorrected distance VA was 0.88�0.17. Best-corrected distance VA changed from 0.91�0.13 preoperatively to0.96�0.09 at 6 months. The overall efficacy index (mean postop-erative uncorrected distance VA/mean preoperative best-correcteddistance VA) at 6 months was 0.97. In the hyperopic group,uncorrected distance VA improved in 100% of the patients. Sixmonths postoperatively, mean uncorrected distance VA was0.89�0.15. Best-corrected distance VA changed from 0.92�0.14preoperatively to 0.94�0.12 at 6 months. The efficacy index at 6months was 0.96.

Predictability

The deviation of the achieved SE refraction from the calculated SErefraction was calculated. After 6 months, all eyes of the myopicand hyperopic groups were within �1.00 D of the desired refrac-tion (Fig 3; R � 0.99 for myopic patients and R � 0.97 for

Figure 1. Changes in best spectacle-corrected distance visual acuity (Bmultifocal intraocular lens implantation in both groups (safety).

Figure 2. Uncorrected distance visual acuity (UCVA) and best spectacle

both groups after clear lens extraction with AcrySof ReSTOR Natural multifo

hyperopic patients). Sixty eyes (90.9%) for the myopic group and140 eyes (88.6%) for the hyperopic group were within �0.50 Dof the target refractive change. The mean postoperative SEs forthe myopic and hyperopic groups were �0.19�0.37 D and�0.23�0.32 D, respectively, at 6 months.

StabilityFor the myopic group, the change of mean SE between 1 and 3months was 0.04 D; between 3 and 6 months, 0.06 D; and overall,0.10 D. For the hyperopic group, the change between 1 and 3months was 0.13 D; between 3 and 6 months, 0.09 D; and overall,0.22 D. Figure 4 shows the results found in both groups.

Near Visual AcuitySafety and efficacy at near vision are depicted in Figures 5 and 6,respectively. In the myopic group, 6 months after surgery none of

) 6 months after clear lens extraction with AcrySof ReSTOR Natural

ected distance visual acuity (BCVA) over the entire follow-up period in

CVA

-corr

cal intraocular lens implantation (efficacy).

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the examined eyes had lost �2 lines of best-corrected distance VA(Fig 5). Five eyes lost 2 lines, 5 eyes lost 1 line, 36 eyes did notchange after surgery, 15 eyes gained 1 line, and 5 eyes gained 2

Figure 3. Attempted versus achieved correction (predictability) 6 mointraocular lens implantation for myopic (R � 0.99) and hyperopic (R � 0D � diopters.

lines of VA. The safety index (ratio of postoperative and preop-

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erative best distance-corrected near VAs) at 6 months was 1.05.Best distance-corrected near VA was maintained at a similar levelafter the surgery (Fig 6). Six months postoperatively, mean uncor-

after clear lens extraction with AcrySof ReSTOR Natural multifocalatients. Correlation coefficients (R) for the groups were similar (P�0.01).

nths.97) p

rected near VA was 0.88�0.15. Best distance-corrected near VA

Fernández-Vega et al � Multifocal Apodized Diffractive IOL after Clear Lens Extraction

changed from 0.85�0.11 preoperatively to 0.90�0.14 at 6 months.The efficacy index (mean postoperative uncorrected near VA/mean preoperative best distance-corrected near VA) at 6 monthswas 1.03. For the hyperopic group, 3 eyes lost 2 lines, 5 eyes lost1 line, 114 eyes had no change in their best distance-corrected nearVA, 20 eyes gained 1 line, and 16 eyes gained 2 lines of VA. Thesafety index at 6 months was 1.11. Best distance-corrected nearVA improved significantly after surgery (Fig 6). Six months post-operatively, mean uncorrected near VA was 0.95�0.08. Bestdistance-corrected near VA changed from 0.86�0.09 preopera-tively to 0.96�0.10 at 6 months. The efficacy index at 6 monthswas 1.10.

No eye required a secondary intervention. No potentially sight-threatening complications such as persistent corneal edema, pupil-lary block, RD, or endophthalmitis were observed during thepostoperative period. In addition, no eye was in the need ofneodymium:yttrium–aluminum–garnet (Nd:YAG) capsulotomy

Figure 4. Time course of the spherical equivalent after clear lens extractiboth groups (stability). D � diopters.

up to the postoperative last visit.

Discussion

New IOLs and lens extraction technology developmenthave allowed that CLE with multifocal IOL implantationwould be considered among refractive surgeons. In addi-tion, the possibility to read comfortably at distance and nearwithout glasses has proven popular among patients. The aimof the present study was to show the visual outcomes foundin a large population of patients submitted to CLE withmultifocal IOL implantation.

Visual Outcomes

We have observed satisfactory visual outcomes in relationto safety indexes (1.05 and 1.02), with most eyes maintain-ing their best-corrected distance VA and some gaining

th AcrySof ReSTOR Natural multifocal intraocular lens implantation for

on wi

multiple lines of best-corrected distance VA (Fig 1). No

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patients lost �2 lines of best-corrected distance VA atfollow-up. Four patients of the myopic group and 17 of thehyperopic group lost 1 line of best-corrected distance VA.About 65% of all patients had no change in their best-corrected distance VA. Thirty percent and 23% of patientsgained �1 lines of best-corrected distance VA in the myo-pic and hyperopic groups, respectively. Comparing bothgroups, myopic patients gained more lines of best-correcteddistance VA than hyperopic patients. Magnification andminimization of the retinal image in myopic and hyperopicpatients, respectively, may play a significant role in thisdifference. Our study shows an improvement in uncorrecteddistance VA after CLE with multifocal IOL implantation forboth groups, with 100% of eyes with uncorrected distanceVA of 20/25 or better at 6 months (Fig 2; P�0.01). Both

Figure 5. Changes in best spectacle-corrected near visual acuity (BCNVAintraocular lens implantation in both groups (safety).

Figure 6. Uncorrected near visual acuity (UCNVA) and best spectacle-c

groups after clear lens extraction with AcrySof ReSTOR Natural multifocal in

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efficacy indexes were good and comparable. Uncorrecteddistance VA and best-corrected distance VA at 6 months forboth groups were about 0.90 and 0.95, respectively. Pre-dictability was also good, with 100% of eyes within the 1-Drange in SE (Fig 3). The myopic group showed a slightlyhigher percentage of eyes (90.9%) within the 0.5-D range inSE than the hyperopic group (88.6%). All patients showeda postoperative SE near emmetropia (about 0.25 D). Forboth groups, the preoperative SE correlated highly with theamount of change in the postoperative SE (Fig 3; R � 0.99for myopic patients and R � 0.97 for hyperopic patients). Interms of stability, our study shows a quite stable SE throughthe follow-up period for the myopic and hyperopic groups,with 0.13 and 0.22 D of SE change, respectively (Fig 4). Atnear vision, none of the examined eyes had lost �2 lines of

nths after clear lens extraction with AcrySof ReSTOR Natural multifocal

ed near visual acuity (BCNVA) over the entire follow-up period in both

) 6 mo

orrect

traocular lens implantation (efficacy).

Fernández-Vega et al � Multifocal Apodized Diffractive IOL after Clear Lens Extraction

best distance-corrected near VA (Fig 5). However, 15% ofmyopic patients lost 1 or 2 lines of best distance-correctednear VA. This percentage was reduced considerably forhyperopic patients, to about 5%. A higher percentage ofhyperopic patients had no change in their best distance-corrected near VA compared with myopic patients. Similarnumbers of myopic and hyperopic patients (about 25%)gained 1 or 2 lines of best distance-corrected near VA. Thesafety index was larger for hyperopic patients. Best distance-corrected near VA in the myopic group was maintained at asimilar level after surgery (Fig 6; P�0.01). However, thehyperopic group showed a statistically significant improve-ment (P�0.01). The efficacy index for the hyperopic groupwas larger than that found for the myopic group (1.11 vs.1.03). Despite this difference, both groups showed good VAat near vision (near to 20/20).

No direct comparison with previous studies of CLE withAcrySof ReSTOR multifocal IOL implantation was possi-ble because this is the first study that evaluates this IOL.However, there are 2 previous studies that evaluated thistechnique with another multifocal IOL: the Array refractivemultifocal IOL.1,2 Although both IOLs are different in termsof optics technology (refractive and surface design), it be-comes interesting to compare with the results found previ-ously. One should consider that differences between resultsmay come from the IOL and also from the sample size ofpatients assessed in each study, among other factors. Arecent study reported by Packer et al1 reviewed the clinicalresults of a bilaterally implanted Array multifocal IOL inCLE patients in 68 eyes (32 bilateral, 4 unilateral). The SEof their patients ranged from �7.50 to �7.37 D. Theyreported that 100% of patients undergoing bilateral implan-tation achieved binocular uncorrected distance VA of 20/40and J5 or better at 1 to 2 months postoperatively. More than90% achieved uncorrected distance VA of 20/30 and J4 orbetter, and nearly 60% achieved uncorrected distance VA of20/25 and J3 or better. We had 100% of patients achieveuncorrected distance VA of 20/30 and J4 or better. Packeret al1 found 80.9% of patients with a postoperative refrac-tive SE within the 0.5-D range. We found better values:90.9% for the myopic group and 88.6% for the hyperopicgroup. Similarly, Packer et al1 reported a high correlationbetween the preoperative SE and amount of change inpostoperative SE (R � 0.99). They found a similar percent-age of patients who had no change in their best-correcteddistance VA (70.6%, vs. our 65%). They concluded thatCLE with the Array multifocal IOL was safe and effective.Another recent study performed on a smaller sample (24myopic and 26 hyperopic eyes) by Dick et al2 showed theefficacy, safety, predictability, stability, and patient satisfac-tion after bilateral CLE with the Array multifocal IOL.Mean SEs of their patients were �7.11�3.25 and�3.04�1.04 D for myopic and hyperopic groups, respec-tively. They found that all eyes were within the 1-D rangeof target refraction. Eighty-six percent of myopic patients(19 eyes) and 88% of hyperopic patients (23 eyes) werewithin the 0.5-D range of the desired refraction. Theseresults are comparable to those found in the present study.At 6 months after surgery, mean SEs for the myopic and

hyperopic patients were �0.07�0.34 and �0.05�0.44 D,

respectively. We reported similar values: �0.19�0.37 Dfor myopic and �0.23�0.32 D for hyperopic patients. Dicket al2 found that no eye in the myopic group and 3 eyes inthe hyperopic group sustained a loss of 1 line of best-corrected distance VA. Eighty-two percent of patients (41eyes) remained unchanged, 10% (5 eyes) had a gain of 1line, and 2% (1 eye) had a gain of 2 lines in best-correcteddistance VA. In all eyes, postoperative uncorrected distanceVA was 20/40 or better. Postoperative uncorrected near VAimproved significantly in these patients, up to J2 and J1 withbest spectacle correction. Considering distance and nearvision, they reported that all patients achieved uncorrecteddistance VA of 20/30 and J4 or better.

Surgical and Postoperative Considerations

Lens removal and replacement with a pseudophakic IOLto reduce or eliminate refractive errors has been per-formed.3–5 Clear lens extraction can be performed withmonofocal, multifocal, or accommodative IOLs. Somecontroversy exists about CLE: the risk of RD and the lossof accommodation.

The risk of late RD for CLE in high myopes has beenwell reported.6,7 Horgan et al7 recently reported that in 62myopic cases of CLE over an 11-year period, a 3.2% RDrate occurred at intervals of 2 and 5 months after surgery.Yttrium–aluminum–garnet laser posterior capsulotomy wasperformed in 61% of patients and did not represent a risk forRD. As we have reported, CLE with multifocal IOL im-plantation results in rapid and predictable improvement inuncorrected distance VA at distance and near vision inmyopic patients. No eye lost vision as a result of RD, and noNd:YAG capsulotomy was necessary in our patients with a6-month follow-up. However, the risks of sight-threateningcomplications inherent in any intraocular procedure under-lie the need for appropriate patient selection. Preoperativeand long-term retinal evaluation is imperative previous tothis procedure to control and treat any possible retinalcomplication. The effectiveness of multifocal IOLs in en-hancing quality of vision has been shown in many clinicalstudies.8,9 Different visual outcomes among IOLs comefrom IOL characteristics. Our results showed good results atdistance and near vision for all patients (100% of patientsachieved uncorrected distance VA of 20/30 and J4 or bet-ter). Mean uncorrected near VAs were 0.88�0.15 for my-opic patients and 0.95�0.08 for hyperopic patients. Patientslost their capability to accommodate, but using multifocal-ity, they achieved acceptable near visual function.

Intraocular Lens Power Selection

One of the most important assessments for successful CLEwith multifocal IOLs use involves precise preoperativemeasurement of axial length and accurate IOL power cal-culation. Keratometry and anterior chamber depth and axiallength measurement should be performed as accurately aspossible. In patients with high ametropia, axial length isdifficult to measure, and then, power selection should beperformed carefully. We chose the SRK/T formula for my-

opic patients because it has been shown to be accurate in

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eyes with a greater axial length.10 The Holladay II formulawas used for hyperopic patients, considering that for shorteyes (about 22.0 mm) it performs better than the SRK/Tformula.11 Our IOL power choice after considering bothformulae was accurate enough to achieve a mean postoper-ative SE of about �0.25 D of the targeted refraction(�0.19�0.37 and �0.23�0.32 D for myopic and hyperopicgroups, respectively). Slightly residual hyperopia between�0.25 and �0.50 D after multifocal IOL implantation hasbeen suggested to avoid halos, preserving distance and nearvision.12,13 Using the SRK/T in myopic eyes and the Hol-laday II in hyperopic eyes for IOL power calculation, min-imal deviation from target refraction was obtained.

Clear lens extraction with AcrySoft ReSTOR multifocalIOL implantation provides stable postoperative refractiveresults, with good vision at distance and near. However,patients should be informed that spectacle independence isnot guaranteed. Some distance residual refractive errorcould appear after IOL implantation. Then, secondary pro-cedures, such as photorefractive keratectomy14 or LASIK,should be considered. In addition, surgeons may combinethis technique with clear corneal incisions to reduce preex-isting astigmatism (up to 3.5 D).15–17

Achieving successful refractive lens exchange depends notonly on patient selection, focusing on the patient’s motivationand expectations, but also on preoperative evaluation targetingaccurate biometry and IOL power calculation. Clear lens ex-traction with multifocal IOLs implantation offers substantialbenefits, especially in patients with hyperopia, those with pres-byopia, and patients with borderline cataract who are request-ing refractive surgery. Refractive surgeons may consider CLEwith AcrySoft multifocal IOL implantation, taking into ac-count the visual outcomes found in this study. Further studiesare needed to assess photic phenomena, such as starbursts andhalos; patient satisfaction; intermediate VA; and the role ofpupil size after this multifocal IOL implantation. We have notdetected safety concerns, but longer periods of postoperativefollow-up are also necessary to confirm the safety of theprocedure.

References

1. Packer M, Fine IH, Hoffman RS. Refractive lens exchangewith the Array multifocal intraocular lens. J Cataract Refract

Surg 2002;28:421–4.

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