CONSISTENT ADVANCES IN CATARACT SURGICAL

Transcription

1 Evaluation of the Aspheric Tecnis Multifocal Intraocular Lens: One-Year Results from the First Cohort of the Food and Drug Administration Clinical Trial MARK PACKER, Y. RALPH CHU, KEVIN L. WALTZ, ERIC D. DONNENFELD, R. BRUCE WALLACE III, KRISTEN FEATHERSTONE, PAMELA SMITH, STANLEY S. BENTOW, AND NICHOLAS TARANTINO PURPOSE: To evaluate the safety and effectiveness of the aspheric diffractive Tecnis multifocal ZM900 (TCMF) intraocular lens (IOL; Abbott Medical Optics, Inc, Santa Ana, California, USA). DESIGN: One-year, nonrandomized, multicenter, evaluator-masked, bilateral, parallel-group comparative clinical evaluation. METHODS: Subjects underwent bilateral implantation with the TCMF IOL or the CeeOn 911A monofocal (CEMN) IOL (Abbott Medical Optics, Inc) according to subject preference. RESULTS: One-year results were available for 244 eyes of 125 TCMF IOL subjects and for 245 eyes of 123 CEMN IOL subjects. Mean distance visual acuities (VAs) were statistically and clinically equivalent between the 2 groups. Mean binocular and monocular uncorrected and distance-corrected near VAs were significantly better for the TCMF IOL versus the CEMN IOL group (P <.0001). A greater proportion of TCMF IOL versus CEMN IOL subjects achieved binocular combined VAs of 20/25 distance and 20/32 near (84.2% [96/114] vs 6.2% [7/113]; P <.0001). The TCMF IOL group had excellent depth of focus, maintaining a mean of 20/40 or better for far, intermediate, and near distances. Mean contrast sensitivity scores were lower for the TCMF IOL versus the CEMN IOL group, but the differences were not considered clinically significant. Halos and night glare were more common in the TCMF IOL versus the CEMN IOL groups. Both reading acuity (20/20 vs 20/47; P <.0007) and speed (148 vs 117 words/minute; P <.0001) were significantly better for the TCMF IOL versus the CEMN IOL group, as were the proportions of the TCMF IOL group versus the CEMN IOL group that achieved spectacle independence (84.8% vs 5.2%; P <.0001) and that functioned comfortably at near without glasses (96.4% vs 30.4%; P <.0001). Accepted for publication Oct 31, From Drs Fine, Hoffman & Packer, LLC, Eugene, Oregon (M.P.); Chu Vision Institute, Edina, Minnesota (Y.R.C.); Eye Surgeons of Indiana, Indianapolis, Indiana (K.L.W.); Ophthalmic Consultants of Long Island, Rockville Centre, New York (E.D.D.); Wallace Eye Surgery, Alexandria, Louisiana (R.B.W.); Abbott Medical Optics, Inc, Santa Ana, California (K.F., P.S., S.S.B., N.T.). Inquiries to Mark Packer, 1550 Oak Street, Suite 5, Eugene, OR ; mpacker@finemd.com CONCLUSIONS: The TCMF IOL provided enhanced near VA, reading acuity per speed, depth of focus, and spectacle independence compared with the monofocal IOL. (Am J Ophthalmol 2010;149: by Elsevier Inc. All rights reserved.) CONSISTENT ADVANCES IN CATARACT SURGICAL techniques and devices have raised patients postoperative expectations from good best-corrected distance visual acuity (BCDVA) to excellent uncorrected distance visual acuity (UCDVA). Having achieved this goal, cataract surgeons are now striving to improve patients postsurgical quality of life by providing good functional uncorrected postoperative visual acuity at both distance and near. The first step toward this goal was the development of the multifocal intraocular lens (IOL). Multifocal IOLs use diffractive or refractive optics to produce 2 or more foci for far, near, and sometimes, intermediate vision. Clinical studies to date demonstrate that subjects successfully learn to attend to the in-focus image and disregard the out-of-focus image(s) produced by multifocal IOLs. 1 In a review of multifocal IOL studies, it was concluded that multifocal IOLs improve near visual acuity without significant degradation of distance visual acuity as compared with monofocal IOLs. 2 Although multifocal IOLs are the only type of IOLs indicated to provide 2.6 to 3.0 diopters (D) of add in the spectacle plane (3.0 to 4.0 D of add in the IOL plane), the splitting of light to multiple foci and the simultaneous in- and out-of-focus images can cause some decrease in contrast sensitivity and may increase the likelihood of experiencing halos and glare compared with traditional monofocal IOLs. An aspheric IOL design improves contrast sensitivity by reducing or canceling the normal positive spherical aberration of the cornea. Improved quality of vision is seen with monofocal aspheric IOL designs. 3 An aspheric multifocal IOL design may reduce the incidence and severity of halo and glare seen with multifocal IOLs. Multifocal IOLs are a success when these drawbacks are more than compensated for by the improvement in range of visual function. Thus, measures of patient satisfaction, although subjective, become very important in determining the effectiveness of a multifocal IOL /10/$ BY ELSEVIER INC. ALL RIGHTS RESERVED. 577 doi: /j.ajo

2 A 2-phase, controlled clinical trial comparing the Tecnis Aspheric Multifocal (TCMF) IOL with the monofocal CeeOn 911A (CEMN) IOL (both from Abbott Medical Optics, Inc, Santa Ana, California, USA) was performed to assess the performance of the TCMF IOL. Results for the first cohort of subjects who completed the 1-year study evaluation are presented here, highlighting measures of visual acuity, quality of vision, and patient satisfaction. METHODS THE INITIAL STUDY PHASE WAS A NONRANDOMIZED, EVALuator-masked, bilateral, comparative, 1-year assessment of the TCMF and the CEMN IOLs. Each patient provided written informed consent for the study before any study procedures were performed. Because not all cataract patients are appropriate candidates for multifocal IOLs, subjects were counseled as to the benefits and drawbacks of each lens and were allowed to choose which type of implant (multifocal or monofocal) they preferred. Subjects enrolled in the study were at least 18 years of age and had visually significant cataracts in both eyes. Inclusion criteria included naturally dilated pupils of 4.0 mm or more in dim light and 1.0 D or less of corneal astigmatism. Subjects were excluded if they used systemic or ocular medications that may affect vision, had any systemic or ocular condition that would increase the operative risk or confound the outcome(s) of the study, or required an intraocular lens of less than 15.0 D or more than 26.0 D. The TCMF IOL used in this study is a second-generation silicone multifocal IOL with a diffractive zone across the posterior surface of the 6.0-mm optic that provides a far and a near focal point that are 4.0 D apart. The lens has the same aspheric, modified prolate design on the anterior surface as the TCMF IOL. 4 The CEMN IOL is a traditional, spherical, monofocal IOL of the same material, haptic, and edge design as the TCMF IOL. The investigators used their standard small-incision phacoemulsification cataract extraction surgical techniques. Pre-existing keratometric astigmatism was managed by incision site placement only. No additional refractive procedures were allowed during the study period. All eyes were targeted for emmetropia. Visual acuities were measured with 100% contrast Early Treatment Diabetic Retinopathy Study acuity charts. Distance visual acuities were tested at 4 m; near visual acuities were tested at a fixed distance of 33 cm as well as at each subject s preferred distance (best distance). Binocular bestcorrected distance defocus visual acuity was tested in 0.5-D increments from 0 to 5 D defocus using a 100% contrast Early Treatment Diabetic Retinopathy Study chart. Binocular best-corrected distance contrast sensitivities were evaluated with Functional Acuity Contrast Test sine wave grating charts with the self-illuminated and FIGURE 1. Bar graph showing the photopic monocular (first eye) and binocular uncorrected distance visual acuities at the 1-year visit for subjects implanted with the Tecnis multifocal intraocular lens (TCMF) or the CeeOn monofocal intraocular lens (CEMN). FIGURE 2. Bar graph showing the photopic monocular (first eye) and binocular best-corrected distance visual acuities at the 1-year visit for subjects implanted with the Tecnis multifocal intraocular lens (TCMF) or the CeeOn monofocal intraocular lens (CEMN). self-calibrated Optec 6500 Vision Tester (StereoOptical Co, Chicago, Illinois, USA) under photopic and mesopic conditions. Photopic testing was at 85 cd/m 2, mesopic testing was at 3 cd/m 2. All test results were adjusted mathematically for the test distances used, and logarithm of the minimal angle of resolution visual acuities were converted to Snellen equivalents for presentation. Binocular reading acuity and speed were assessed with MN- READ continuous-text acuity charts (Lighthouse Low Vision Products, Long Island City, New York, USA) with distance correction in place at the subject s best distance. Contrast sensitivity, reading ability, and defocus testing were performed only at 4 to 6 months after surgery. Questionnaires assessing functional vision and patient 578 AMERICAN JOURNAL OF OPHTHALMOLOGY APRIL 2010

3 TABLE 1. Near Visual Acuities as Mean Early Treatment Diabetic Retinopathy Study Chart Lines Standard Deviation (Snellen Equivalent) Photopic UCNVA Photopic DCNVA Mesopic DCNVA Near Visual Acuity TCMF CEMN TCMF CEMN TCMF CEMN Monocular 33 cm (20/32) (20/84) (20/28) (20/87) (20/50) (20/130) Monocular best distance (20/29) (20/76) (20/26) (20/80) (20/45) (20/120) Binocular 33 cm (20/25) (20/63) (20/24) (20/70) (20/39) (20/104) Binocular best distance (20/24) (20/57) (20/23) (20/64) (20/37) (20/99) CEMN CeeOn monofocal intraocular lens; DCNVA distance-corrected near visual acuity; TCMF Tecnis multifocal intraocular lens; UCNVA uncorrected near visual acuity. UCNVA and DCNVA were measured under photopic conditions; DCNVA was also measured under mesopic conditions. At both standardized (33 cm) and patient best near distance, mean UCNVA and DCNVA consistently were better for aspheric TCMF eyes compared with CEMN eyes, whether measured monocularly (TCMF, n 116; CEMN, n 113) or binocularly (TCMF, n 114; CEMN, n 113). satisfaction were administered over the phone by a trained individual who was masked as to the IOL implanted. Comparisons between IOL groups for categorical data such as gender, race, preoperative acuity, and so forth were performed using the Fisher exact test. Comparisons between IOL groups for age were performed using 2-sample t-tests. For uncorrected near visual acuity (UCNVA), distance-corrected near visual acuity (DCNVA), reading acuity, reading speed, defocus, and optical visual symptoms, all results were compared between IOL groups using the Wilcoxon rank-sum test. For distance visual acuity data, a nonequivalence approach using 90% confidence intervals was used to determine if the mean for multifocal eyes was within 1 line of the mean for monofocal eyes. Unless otherwise indicated, 2-sided testing was performed with set at RESULTS A TOTAL OF 248 SUBJECTS WERE IMPLANTED ACROSS 13 sites in the United States between November 29, 2004, and December 21, The TCMF IOL was implanted in 244 eyes of 125 subjects; the CEMN IOL was implanted in 245 eyes of 123 subjects. One-year data as of February 27, 2007, were available from 94.4% (118/125) of TCMF IOL subjects and from 94.3% (116/123) of CEMN IOL subjects. Seven TCMF IOL subjects were not included in this analysis because of declining to participate further (n 2), lens explantation (n 1), death (n 1), loss to follow-up (n 1), and lack of 1 year bilateral data because of delayed implantation of the second eye (n 2). Seven CEMN IOL subjects were not included because of declining to participate further (n 3), death (n 1), illness (n 2), and loss to follow-up (n 1). Mean age was years for the TCMF IOL group and years for the CEMN IOL group. Although statistically significant (P.0458), the difference in mean age of 2.3 years was not clinically significant. Most of each group were white (TCMF, 100%; CEMN, 92.7%) and predominantly female (TCMF, 63.2%; CEMN, 65.9%). For most eyes, preoperative pupil size was at least 4 mm under photopic conditions and from 4 to 5 mm under mesopic conditions. All monocular results presented are for first eyes. Additional surgical procedures or complications were rare for either lens group. There were 3 lens-related secondary surgical interventions in a single TCMF subject who underwent a pupilloplasty and bilateral lens explantation. In this subject, there was a misalignment of less than 0.5 mm between the IOL and the dilated pupil because of a slight difference in anatomic position. Pupilloplasty was undertaken in 1 eye in an effort to alleviate halos and glare, but ultimately both eyes underwent lens exchange for a monofocal IOL. Four lenses were exchanged in the TCMF IOL group: 3 because of errors in refractive power, and 1 because of implantation of an incorrect lens. There were no lens explantations or exchanges in the CEMN IOL group. Neodymium:yttrium aluminum garnet capsulotomy was performed on 12.8% (16/125) of TCMF IOL and 4.9% (6/123) of CEMN IOL first eyes (P.0425). There were no significant differences in postoperative photopic or mesopic pupil size, spherical equivalent correction achieved, or absolute postoperative cylinder between the 2 groups. Mean postoperative spherical equivalents were within 0.25 D of plano (TCMF IOL, D; CEMN IOL, D). Mean deviation from the targeted refraction (emmetropia) was similar for the 2 groups (TCMF IOL, ; CEMN IOL, ; P.12). At 1 year, based on confidence interval analyses, the 2 groups were equivalent (defined as a difference of less than 1 Snellen line) for mean monocular (TCMF [20/28]; CEMN [20/24]) and binocular (TCMF IOL, [20/22]; CEMN IOL, [20/20]) UCDVA as well as monocular (TCMF IOL, [20/21]; CEMN IOL, [20/19]) and VOL. 149, NO. 4 TECNIS MULTIFOCAL IOL CLINICAL TRIAL 579

4 FIGURE 3. Bar graph showing the 1-year binocular photopic uncorrected near visual acuity (UCNVA) and distance-corrected near visual acuity (DCNVA) at subject s best distance for individuals implanted with the Tecnis multifocal intraocular lens (TCMF) or the CeeOn monofocal intraocular lens (CEMN). FIGURE 5. Graph showing the mean binocular best-corrected distance defocus visual acuity with natural pupil size for subjects implanted with the Tecnis multifocal intraocular lens (TCMF) or the CeeOn monofocal intraocular lens (CEMN). FIGURE 4. Bar graph showing the uncorrected (UCVA) binocular combined distance and near (33 cm) visual acuity and distance-corrected binocular combined distance and near (33 cm) visual acuity (DCVA) at the 1-year visit for subjects implanted with the Tecnis multifocal intraocular lens (TCMF) or the CeeOn monofocal intraocular lens (CEMN). binocular (TCMF IOL, [20/18]; CEMN IOL, [20/17]) BCDVA. All subjects in both lens groups achieved a binocular UCDVA of 20/40 or better; however, more CEMN IOL subjects achieved binocular UCDVA of 20/20 or better (77.2%; 88/114) compared with TCMF IOL subjects (57.9% [66/114]; Figure 1). All subjects in both groups achieved monocular and binocular BCDVA of 20/40 or better; additionally, the same proportions of subjects in both lens groups achieved monocular and binocular BCDVA of 20/25. A slightly higher percentage of subjects achieved monocular and binocular BCDVA of 20/20 or better in the CEMN IOL group compared with the TCMF IOL group (Figure 2). FIGURE 6. Graph showing the mean binocular best-corrected distance defocus visual acuity for Tecnis multifocal intraocular lens subjects by pupil size group (small, medium, large) at the 4- to 6-month visit. Monocular and binocular UCNVA and DCNVA were tested at 33 cm, the theoretical best test distance for the TCMF IOL, and at the subject s best near distance. In all comparisons, the mean score for the TCMF IOL group was significantly better (P.0001) than that of the CEMN IOL group by approximately 4 to 5 lines of near acuity (Table 1). The percentage of subjects achieving better binocular UCNVA and DCNVA scores at both 33 cm and at best distance was substantially greater in the TCMF IOL group compared with the CEMN IOL group (Figure 3). With near add in place, there was no significant difference between the groups in mean best-corrected near acuity at best distance (P.1167). The proportion of subjects achieving binocular combined visual acuities of 20/40 distance and 20/40 near 580 AMERICAN JOURNAL OF OPHTHALMOLOGY APRIL 2010

5 TABLE 2. Frequency of Spectacle Wear for Patients Implanted with the Aspheric Tecnis Multifocal Intraocular Lens or the CeeOn Monofocal Intraocular Lens TCMF CEMN P Value FIGURE 7. Graph showing the mean binocular best-corrected distance contrast sensitivity scores at the 4- to 6-month visit for subjects implanted with the Tecnis multifocal intraocular lens (TCMF) or the CeeOn monofocal intraocular lens (CEMN) under photopic conditions (85 cd/m 2 ) with glare and mesopic conditions (3 cd/m 2 ) with and without glare (18 cpd not tested under mesopic conditions). ( 98% for TCMF IOL vs 22% for CEMN IOL) or 20/25 distance and 20/32 near ( 84% for TCMF IOL vs 7% for CEMN IOL) at 33 cm was significantly greater (P.0001) for the TCMF IOL group than the CEMN IOL group for both UCNVA and DCNVA (Figure 4). The depth-of-focus curves for the TCMF and CEMN IOL groups are shown in Figure 5. Mean visual acuity for the TCMF IOL group remained at 20/40 or better for far, intermediate, and near distances, through 4 D of defocus. Mean visual acuity for the CEMN IOL group was similar to that of the TCMF IOL group through 1.5 D of defocus, then decreased steadily as defocus increased. Regardless of pupil size, mean visual acuity in the TCMF IOL group typically remained 20/40 or better through far, intermediate, and near distances (Figure 6). Mean contrast sensitivity scores were lower for the TCMF IOL group compared with the CEMN IOL group under all lighting conditions (Figure 7). However, the mean difference between lens groups did not reach clinical significance (generally regarded as 0.30 log units) 5 under any test condition. With distance correction in place, the TCMF IOL group read text of a significantly smaller print size (P.0001) than the CEMN IOL group at best distance. The smallest print size read for the TCMF IOL group was equivalent to a Snellen score of 20/20, compared with 20/47 for the CEMN IOL group. Reading speed also was significantly better for the TCMF IOL group (P.0007), reading 148 words per minute at a smaller critical print size of Snellen 20/30 compared with 117 words per minute at Snellen 20/63 for the CEMN IOL group. For each eye, subjects were asked by investigators if they were having any difficulties with their vision. At 1 year, night glare (15.5% [18/116]) and halos (22.4% [26/116]) Spectacle wear.0001 overall Never 84.8% (95/112) 5.2% (6/115) Sometimes 13.4% (15/112) 83.5% (96/115) Always 1.8% (2/112) 11.3% (13/115) Spectacle wear.0066 for distance Never 95.5% (107/112) 80.9% (93/115) Part of the time 1.8% (2/112) 8.7% (10/115) Always 2.7% (3/112) 10.4% (12/115) Spectacle wear.0001 for near Never 86.6% (97/112) 5.2% (6/115) Part of the time 12.5% (14/112) 72.2% (83/115) Always 0.9% (1/112) 22.6% (26/115) CEMN CeeOn monofocal intraocular lens; TCMF Tecnis multifocal intraocular lens. were the most frequently reported symptoms for the TCMF IOL group (first eye). Most reports of night glare were moderate (10.3% [12/116]), and only 2.6% (3/116) were severe. Most halos were rated as mild (12.1% [14/116]), with 5.2% (6/116) reported as moderate and 5.2% (6/116) reported as severe. For CEMN IOL first eyes, the most reported optical or visual symptom at 1 year also was halos (8.6% [10/116]), with most reports being mild in severity. Night glare was reported by 4.3% (5/116) CEMN IOL subjects. At 1 year, the great majority of subjects were satisfied with their lens choice: 94.6% (106/112) of TCMF IOL subjects and 89.6% (103/115) of CEMN IOL subjects reported they would elect the same IOL again. The most common reason for not electing the same IOL again was poor near vision, all from CEMN IOL subjects. The mean rating of vision without spectacles (on a scale of 1 to 10) was significantly better (P.0001) for the TCMF IOL group ( ) than the CEMN IOL group ( ). Spectacle independence was significantly greater for the TCMF IOL compared with the CEMN IOL group (84.8% [95/112] vs 5.2% [6/115]; P.0001; Table 2). Subjects also reported if they were able to function comfortably at near (TCMF, 96.4% [108/112]; CEMN, 30.4% [35/115]), intermediate (TCMF, 93.8% [105/112]; CEMN, 84.2% [96/115]), or far (TCMF, 96.4% [108/112]; CEMN, 98.3% [113/115]) distances without spectacles. A significantly greater proportion of the TCMF IOL group were able to function comfortably at near (P.001) and intermediate (P.0324) distances compared with the CEMN IOL group. There was no significant difference between the 2 VOL. 149, NO. 4 TECNIS MULTIFOCAL IOL CLINICAL TRIAL 581

6 groups in their ability to function comfortably at far distances (P.4417). DISCUSSION IN THIS COMPARISON OF THE ASPHERIC TCMF IOL AND THE monofocal CEMN IOL, all subjects achieved monocular and binocular BCDVA of 20/40 or better. The difference in mean monocular or binocular UCDVA between lens groups was never more than 1 Snellen line, and the 2 groups were considered to be statistically and clinically equivalent. Overall, the TCMF IOL group results are comparable with those of other published studies of current diffractive multifocal intraocular lenses (MIOLs) that report mean UCDVA between Snellen 20/20 and 20/ Mean UCNVA and DCNVA were substantially better in the TCMF IOL group by approximately 4 to 5 lines of acuity. As a result of the simultaneous distance and near vision provided by the multifocal IOL, distance contrast sensitivity scores were lower for the TCMF IOL group than for the CEMN IOL group. However, the difference was never more than 0.30 log units, and therefore was not considered clinically significant. 5 The TCMF IOL group demonstrated significantly better distance-corrected reading acuity and speed, more extensive depth of focus, and significantly greater spectacle independence than the CEMN IOL group. Compared with the monofocal CEMN IOL, the TCMF IOL provided good functional near visual acuity without clinically significant decrements in distance visual acuity or contrast sensitivity. It should be noted that astigmatic correction was not allowed by the study protocol. Minimizing astigmatism using limbal relaxing incisions (LRIs), or other techniques, is essential when implanting multifocal IOLs to minimize any decrease in quality of vision. 14 In addition, because all multifocal IOLs split the incoming light to 2 foci or more, a 50% decrement in light at the focal point theoretically leads to a 1-line decrement in visual acuity. 15 This may explain the slightly lower proportion of the TCMF IOL population achieving BCDVA of 20/20 or better; however, the proportion of subjects achieving BCDVA of 20/25 or better was identical for the 2 groups. Depth-of-focus testing demonstrated excellent functional vision in the TCMF IOL group, with significant peaks at both distance and near. The study also demonstrated good functional intermediate vision, which is not generally considered a feature of bifocal diffractive MIOLs. In a defocus study comparing the TCMF IOL with an apodized diffractive MIOL, the TCMF IOL performed better than the apodized diffractive MIOL at intermediate distances of 50 and 100 cm. 16 Functional intermediate vision with the TCMF IOL is supported further by an intermediate vision study of 30 MIOL subjects in which subjects with the TCMF IOL outperformed subjects with either an apodized diffractive MIOL or a first-generation refractive MIOL in tests of reading speed. 17 It has been suggested that the improved performance of the TCMF IOL at intermediate distances may be related in part to the slightly wider diameter of its central zone compared with the apodized diffractive MIOL (Weeber H, Piers P. Intermediate vision with Tecnis multifocal IOLs. Paper presented at the XXVI Congress of the ESCRS. September 13-17, 2008; Berlin, Germany). Consistent with previous studies of multifocal IOLs, mean contrast sensitivity scores in the TCMF IOL group were lower than those in the CEMN IOL group, although the differences were not considered clinically significant at any spatial frequency. The loss of a small percentage of incoming light to the diffractive optics of the lens as well as the simultaneous in- and out-of-focus images resulting from the multifocality of the lens can cause a decrease in contrast sensitivity compared with a monofocal IOL. These differences may be greater in a comparison with an aspheric monofocal IOL. The contrast sensitivity differences reported here are similar to the performance reported for the apodized diffractive MIOL under both photopic and mesopic conditions when compared with a monofocal lens of similar design. 18,19 In a direct comparison of the TCMF IOL (n 14) and the apodized diffractive MIOL (n 14), there were no significant differences in high- or lowcontrast distance visual acuities between the 2 groups. 16 These results may be considered surprising, because the apodized diffractive MIOL has an outer refractive annulus that increases the amount of light focused for distance vision under low-light conditions compared with the TCMF IOL in which the diffractive zone covers the entire optic. However, this finding may be related to the aspheric design of the TCMF IOL compared with the spherical design of the apodized diffractive MIOL. Wavefront testing has demonstrated that the root mean squares of spherical, coma, and total higher-order wavefront aberrations were significantly lower in eyes implanted with the TCMF IOL as compared with eyes implanted with the apodized diffractive MIOL. 16 Overall, studies of aspheric IOLs have shown decreased wavefront spherical aberrations and improved contrast sensitivity compared with spherical IOLs. 20,21 The multifocal IOL group reported more visual symptoms, particularly halos and night glare, than those who received monofocal IOLs. Most nighttime symptoms in TCMF eyes generally were rated as mild to moderate and decreased over the duration of the trial; however, in 1 TCMF subject, bilateral lens exchange was necessary because of severe halos and glare. Overall, most symptoms were rated in the mild to moderate range and decreased over the duration of the trial. Similar results over time were described in the Cochrane database review of multifocal IOLs. 2 The high subject satisfaction ratings for the TCMF IOL group suggest that the visual symptoms did not interfere with everyday activities. Additionally, a higher proportion of subjects in the TCMF IOL group were 582 AMERICAN JOURNAL OF OPHTHALMOLOGY APRIL 2010

7 satisfied with their lens of choice compared with the CEMN subjects, indicating that the benefits of the multifocal lens generally outweigh the presence of optical visual symptoms with regard to subject satisfaction. Neodymium:yttrium aluminum garnet laser capsulotomy was performed in a greater percentage of TCMF IOL compared with CEMN IOL eyes at the 1-year visit. Because the 2 IOLs were identical except for the addition of a multifocal diffraction grating to the TCMF IOL, it is unlikely that the difference in posterior capsule opacification rates was the result of design or material differences between the lenses. It has been suggested that lower grades of posterior capsule opacification may become visually significant in eyes with a multifocal IOL because of the multiple focal points and slight decrease in light intensity at the retina resulting from the diffractive design. 22,23 This may explain the higher rate of neodymium:yttrium aluminum garnet capsulotomy in the TCMF IOL group. A good measure of functionality for a multifocal IOL is the proportion of subjects achieving spectacle independence. At 1 year, a significantly greater proportion of the TCMF IOL group never wore spectacles compared with the CEMN IOL group. Smaller studies of the TCMF IOL have reported spectacle independence levels of 77% to 86%. 11,13,24 These results are consistent with studies of multifocal IOLs in which spectacle independence ranges from 41% to 81% and is significantly greater than that for comparative monofocal IOLs. 2,11,13,18,19,25 Spectacle independence in the TCMF IOL group also was greater than that reported in a prospective study of 26 subjects (25%) 26 and a retrospective study of 86 subjects (76.8%) 27 implanted with monofocal IOLs and targeted for monovision. In addition, a significantly greater proportion of TCMF IOL than CEMN IOL subjects were able to function comfortably without spectacles at both near and intermediate distances with no significant difference in the proportion functioning comfortably at far distances. The ability to function comfortably without spectacles was fairly uniform for the TCMF IOL group across near, intermediate, and far distances. A key reason for subjects choosing a multifocal over a monofocal IOL is the desire to be spectacle free for reading. With best-distance correction in place, and using their preferred reading distance to remove the effects of astigmatism and residual amounts of defocus, the TCMF IOL group performed significantly better on both reading acuity and reading speed tests compared with the CEMN IOL group. The TCMF IOL also performed well in a series of tests using Radner reading charts. 17,28 When comparing a first-generation refractive MIOL (Array MIOL; Abbott Medical Optics, Inc, Santa Ana, California, USA), an apodized diffractive MIOL, and the TCMF IOL, the apodized diffractive MIOL and the TCMF IOL significantly outperformed the refractive MIOL in photopic conditions. The TCMF IOL outperformed the apodized diffractive MIOL under photopic conditions, but the differences were not statistically significant. The TCMF IOL significantly outperformed both the apodized diffractive and first-generation refractive MIOLs under mesopic conditions. In summary, the TCMF IOL provided subjects with significantly enhanced near vision without significant loss of distance visual function compared with a monofocal IOL. Although a slight decrease in contrast sensitivity and an increase in photic phenomena were noted with the TCMF IOL, subject satisfaction was very high for the lens, likely a result of improved reading ability, the low incidence of spectacle wear, and the large range of depth of focus provided by the aspheric TCMF IOL. SUPPORTED BY ABBOTT MEDICAL OPTICS, INC (AMO), SANTA ANA, CALIFORNIA. MARK PACKER IS A CONSULTANT TO AMO; Bausch & Lomb, Inc (B&L); and Visiogen, Inc. Y. Ralph Chu is a consultant to AMO and B&L and has received speaker support from AMO and B&L. Kevin L. Waltz is a consultant to AMO and eyeonics/b&l, receives periodic payments for intellectual property from B&L, and has provided testimony as an expert witness related to multifocal intraocular lenses. Eric D. Donnenfeld is a consultant to AMO, Alcon, Inc, and B&L. R. Bruce Wallace is a consultant to B&L and AMO. Kristen Featherstone, Pamela Smith, Stanley S. Bentow, and Nicholas Tarantino are employees of AMO. Involved in design and conduct of study (M.P., K.F., P.S., S.S.B., N.T.); Collection of data (M.P., Y.R.C., K.L.W., E.D.D., R.B.W.); Management and analysis of data (K.F., P.S., S.S.B., N.T.); Interpretation of data (M.P., Y.R.C., K.L.W., E.D.D., R.B.W., K.F., P.S., S.S.B., N.T.); and Preparation, review, or approval of the manuscript (M.P., Y.R.C., K.L.W., E.D.D., R.B.W., K.F., S.S.B., N.T.). The protocol and informed consent were approved by a central institutional review board (RCRC Independent Review Board) or by a site s local institutional review board. The study was conducted in accordance with the principles stated in the Declaration of Helsinki and complied with the Health Insurance Portability and Accountability Act. Written informed consent was obtained from all subjects before initiation of any study-related procedure. The authors thank the additional investigators who also participated in this phase of the trial: Kerry Assil, Frank Bucci, Elizabeth Davis, William Fishkind, J. Rex Parent, Kerry Solomon, and Jeffrey Whitsett. Additionally, the authors thank Carolyn A. Bates, Biomedical Strategic Communications, Tustin, California, for manuscript preparation. REFERENCES 1. Kaymak H, Fahle M, Ott G, Mester U. Intraindividual comparison of the effect of training on visual performance with ReSTOR and Tecnis diffractive multifocal IOLs. J Refract Surg 2008;24: Leyland M, Pringle E. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev 2006;18:CD Dick HB. Recent developments in aspheric intraocular lenses. Curr Opin Ophthalmol 2009;20: Holladay JT, Piers PA, Koranyi G, van der Mooren M, Norrby NE. A new intraocular lens design to reduce spherical aberration of pseudophakic eyes. J Refract Surg 2002;18: American National Standard for Ophthalmics. ANSI Z80.12 Ophthalmics Multifocal Intraocular Lenses. New York: ANSI, Blaylock JF, Si Z, Aitchison S, Prescott C. Visual function and change in quality of life after bilateral refractive lens VOL. 149, NO. 4 TECNIS MULTIFOCAL IOL CLINICAL TRIAL 583

8 exchange with the ReSTOR multifocal intraocular lens. J Refract Surg 2008;24: Chang DF. Prospective functional and clinical comparison of bilateral ReZoom and ReSTOR intraocular lenses in patients 70 years or younger. J Cataract Refract Surg 2008;34: Chiam PJ, Chan JH, Agarwal RK, Kasaby S. ReSTOR intraocular lens implantation in cataract surgery: quality of vision. J Cataract Refract Surg 2006;32: Fernández-Vega L, Alfonso JF, Rodríguez PP, Montéls-Micó R. Clear lens extraction with multifocal apodized diffractive intraocular lens implantation. Ophthalmology 2007;114: Goes FJ. Refractive lens exchange with the diffractive multifocal Tecnis ZM900 intraocular lens. J Refract Surg 2008;24: Martínez Palmer A, Gómez Faiña P, España Albelda A, Comas Serrano M, Nahra Saad D, Castilla Cespedes Visual function with bilateral implantationspedes M. Visual function with bilateral implantation of monofocal and multifocal intraocular lenses: a prospective, randomized, controlled clinical trial. J Refract Surg 2008;24: Vingolo EM, Grenga P, Iacobelli L, Grenga R. Visual acuity and contrast sensitivity: AcrySof ReSTOR apodized diffractive versus AcrySof SA60AT monofocal intraocular lenses. J Cataract Refract Surg 2007;33: Zeng Z, Chen X-F, Ye J. Visual function of diffractive aspherical multifocal intraocular lens. Int J Ophthalmol 2008;8: Ravalico G, Parentin F, Baccara F. Effect of astigmatism on multifocal intraocular lenses. J Cataract Refract Surg 1999; 25: Holladay JT, Van Dijk H, Lang A, et al. Optical performance of multifocal intraocular lenses. J Cataract Refract Surg 1990;16(4): Toto L, Falconio G, Vecchiarino L, et al. Visual performance and biocompatibility of 2 multifocal diffractive IOLs: sixmonth comparative study. J Cataract Refract Surg 2007;33: Hütz WW, Eckhardt HB, Röhrig B, Grolmus R. Intermediate vision and reading speed with Array, Tecnis, and ReSTOR intraocular lenses. J Refract Surg 2008;24: Acrysof ReSTOR Apodized Diffractive Optic Posterior Chamber Intraocular Lenses, Models MA60D3 and SA60D3-P Professional Labeling. Available at: Accessed June 16, Bi H, Cui Y, Ma X, et al. Early clinical evaluation of AcrySof ReSTOR multifocal intraocular lens for treatment of cataract. Ophthalmologica 2008;222: Packer M, Fine IH, Hoffman RS. Wavefront technology in cataract surgery. Curr Opin Ophthalmol 2004;15: Bellucci R, Morselli S. Optimizing higher-order aberrations with intraocular lens technology. Curr Opin Ophthalmol 2007;18: Muftuoglu O, Prasher P, Chu C, et al. Laser in situ keratomileusis for residual refractive errors after apodized diffractive multifocal intraocular lens implantation. Cataract Refract Surg 2009;35: Hoffman RS, Fine IH, Packer M. Refractive lens exchange with a multifocal intraocular lens. Curr Opin Ophthalmol 2003;14: Mester U, Hunold W, Wesendahl T, Kaymak H. Functional outcomes after implantation of Tecnis ZM900 and Array SA40 multifocal intraocular lenses. J Cataract Refract Surg 2007;33: Kohnen T, Allen D, Boureau C, et al. European multicenter study of the AcrySof ReSTOR apodized diffractive intraocular lens. Ophthalmology 2006;113: Finkelman YM, Ng JQ, Barrett GD. Patient satisfaction and visual function after pseudophakic monovision. J Cataract Refract Surg 2009;35: Ito M, Shimizu K, Amano R, Handa T. Assessment of visual performance in pseudophakic monovision. J Cataract Refract Surg 2009;35: Hütz WW, Eckhardt HB, Röhrig B, Grolmus R. Reading ability with 3 multifocal intraocular lens models. J Cataract Refract Surg 2006;32: AMERICAN JOURNAL OF OPHTHALMOLOGY APRIL 2010

9 Biosketch Mark Packer graduated cum laude from Harvard University, receiving both an Honorary National Scholarship and a Harvard Scholarship. He received his medical degree from the University of California at Davis and completed his residency training in Ophthalmology at Boston University Medical Center; he achieved American Board of Ophthalmology Certification in 1997 and Recertification in He currently serves as Clinical Associate Professor of Ophthalmology at Oregon Health & Science University. VOL. 149, NO. 4 TECNIS MULTIFOCAL IOL CLINICAL TRIAL 584.e1