A prospective comparative study of the amo array zonal-progressive multifocal silicone intraocular lens and a monofocal intraocular lens

doi:10.1016/S0161-6420(99)00704-6

Ophthalmology

Volume 106, Issue 7, 1 July 1999, Pages 1243-1255

Presented in part at the American Society of Cataract and Refractive Surgery meeting, Boston, Massachusetts, April 1997; the European Society of Cataract and Refractive Surgery meeting, Prague, Czech Republic, September 1997; and the American Society of Cataract and Refractive Surgery meeting, San Diego, California, May 1998.

https://doi.org/10.1016/S0161-6420(99)00704-6 Get rights and content

Abstract

Objective

To evaluate the safety and effectiveness of a zonal-progressive multifocal silicone intraocular lens (IOL).

Design

Prospective, nonrandomized, fellow eye comparative trial.

Participants

Four hundred fifty-six subjects were enrolled at 14 investigational sites in the United States; 400 subjects achieved 1-year follow-up. A subset of 123 subjects (102 at 1 year) were enrolled in a monofocal fellow eye control substudy; subjects were implanted with the multifocal IOL in one eye and a comparable monofocal IOL in the fellow eye.

Methods

Cataract extraction and implantation of a zonal-progressive multifocal silicone IOL was performed using the surgeon’s standard technique. Subjects were followed at six postoperative examination intervals through 1 year.

Main outcome measures

The key efficacy measures were mean uncorrected and corrected distance and near visual acuity at 1 year after surgery.

Results

In the monofocal fellow eye control substudy, the multifocal eyes showed a mean 2-line increase over monofocal eyes for uncorrected and distance-corrected near visual acuity (P < 0.0001). Mean uncorrected distance visual acuity was similar between multifocal and monofocal eyes (P = 0.116). A significantly higher proportion of bilateral multifocal subjects reported that they could function comfortably without glasses at near (81%, 96 of 118) compared with multifocal/monofocal subjects (56%; 93 of 165; P < 0.001) and unilateral multifocal subjects (58%; 56 of 97; P < 0.001). Low-contrast visual acuity was reduced in multifocal eyes by approximately 1 Snellen line. However, no perceived disadvantages attributable to the reduction in low-contrast acuity were found. Although the perception of halos and glare increased in the multifocal eyes, good visual function remained, and nearly all subjects were satisfied with the results of their surgery.

Conclusions

In a large study that included a subset of subjects with paired eye compared with those with monofocal lenses, this zonal-progressive multifocal lens provided a high level of uncorrected and corrected distance vision, improved uncorrected and distance-corrected near vision, reduced spectacle dependency, and a high level of patient satisfaction despite some loss of low-contrast visual acuity and increased reports of halos and glare.

Section snippets

Subject population

At the 14 participating study sites, eligible subjects and were at least 60 years of age and had unilateral or bilateral cataracts. Eligible subjects typically had a preoperative best-corrected visual acuity (distance) worse than 20/40, glare visual acuity test results worse than 20/40, or functionally disabling complaints about their vision. By investigator examination and judgment, subjects were also required to have the potential for postoperative visual acuity of 20/30 or better, express a

Results

Four hundred fifty-six subjects were enrolled in this study, with implantations occurring between December 1993 and May 1995. Of these subjects, 123 were in the monofocal/multifocal subset. For the remaining 333 subjects, the fellow eye was either pseudophakic (with zonal-progressive multifocal optic, n = 147, or conventional monofocal, n = 73) or phakic (n = 113). For the 73 conventional monofocal eyes, implantation may have been at any time before implantation of the multifocal IOL or at some

Discussion

This study evaluated the safety and efficacy of the AMO ARRAY zonal-progressive multifocal lens (Allergan), the first multifocal IOL approved by the FDA for commercial distribution in the United States.

The paired-comparison subgroup of the monofocal and multifocal lens (N = 102) allowed for intraocular comparisons without the issues of interpatient variability. Complications were of the type and incidence to be expected with cataract extraction and IOL implantation in a patient population, the

References (27)

H.V. Gimbel et al.
Visual and refractive results of multifocal intraocular lenses
Ophthalmology
(1991)
J.T. Holladay et al.
Optical performance of multifocal intraocular lenses
J Cataract Refract Surg
(1990)
H.C. Zisser et al.
Photographic simulation of image quality through bifocal intraocular lenses
Am J Ophthalmol
(1989)
N.H. Atebara et al.
An optical model to describe image contrast with bifocal intraocular lenses
Am J Ophthalmol
(1990)
R.J. Duffey et al.
Multifocal intraocular lenses
J Cataract Refract Surg
(1990)
T.E. Hansen et al.
New multifocal intraocular lens design
J Cataract Refract Surg
(1990)
T. Olsen et al.
Contrast sensitivity as a function of focus in patients with the diffractive multifocal intraocular lens
J Cataract Refract Surg
(1990)
F.T. Ellingson
Explantation of 3M diffractive intraocular lenses
J Cataract Refract Surg
(1990)
P. Percival
Indications for the multizone bifocal implant
J Cataract Refract Surg
(1990)
R.F. Steinert et al.
A prospective, randomized, double-masked comparison of a zonal-progressive multifocal intraocular lens and a monofocal intraocular lens
Ophthalmology
(1992)

J.T. Holladay et al.

Mean visual acuity

Am J Ophthalmol

(1991)

G.U. Auffarth et al.

Depth of focus and functional results in patients with multifocal intraocular lensesa long-term follow-up

J Cataract Refract Surg

(1993)

L. Rossetti et al.

Performance of diffractive multifocal intraocular lenses in extracapsular cataract surgery

J Cataract Refract Surg

(1994)

Cited by (247)

ISBCS and presbyopia correcting intraocular lenses
2022, Immediately Sequential Bilateral Cataract Surgery (ISBCS): Global History and Methodology
Immediate Sequential Bilateral Cataract Surgery (ISBCS) can be offered with implantation of presbyopia correcting lenses to select patients without significant ocular comorbidities. When done properly, this practice, in comparison with delayed sequential bilateral cataract surgery (DSBCS), offers patients significant advantages in terms of convenience and faster neuroadaptation with no anisometropic interval. Although the cost difference between a monofocal intraocular lens and presbyopia correcting solutions might not change the basic expectations of improved vision that cataract surgery patients have, failure to meet expectations of patients choosing presbyopia correcting lenses can cause significant dissatisfaction. The goal of this chapter is to provide the ISBCS surgeon with advice for successful implantation of these lenses and tools to avoid suboptimal outcomes in order to achieve maximal patient satisfaction. The information contained herein is equally useful for DSBCS cases.
Ophthalmologic Applications
2020, Biomaterials Science: An Introduction to Materials in Medicine
Biomaterials in ophthalmic applications have a long and very successful history. Among the first ophthalmic biomaterials, intraocular lenses have been restoring sight to patients for more than 50 years. This chapter will describe innovations in contact lens materials including the advent of silicone hydrogel materials and their growing use. Changes in intraocular lenses and the potential for the development of a truly accommodating intraocular lens will be discussed. The emerging use of biomaterials in the treatment of glaucoma is a newer application of biomaterials in the eye. The use of biomaterials to create artificial retinas and the potential for the application of these novel devices to restore sight to patients who no longer have or who never had vision will be described.
Primary sulcus implantation of a diffractive multifocal pseudophakic piggyback intraocular lens
2018, Journal of Cataract and Refractive Surgery
To evaluate the efficacy and safety of the combined implantation of a monofocal intraocular lens (IOL) in the capsular bag with a diffractive multifocal IOL designed for sulcus placement (Reverso).
Purpan Hospital, Toulouse, and Helios Clinic, Saint-Jean-de-Luz, France.
Prospective case series.
The multifocal IOL piggyback IOL was implanted in the sulcus during cataract surgery. Visual acuity, defocus curve, contrast sensitivity, IOL positioning, and patient satisfaction were assessed with 1-year follow-ups.
Fifty-four eyes of 27 patients were included. At 1-month, monocular uncorrected distance (UDVA) and near (UNVA) visual acuities were 0.13 logarithm of the minimum angle of resolution (logMAR) ± 0.18 (SD) and 0.20 ± 0.16 logMAR, respectively. Binocular UDVA and UNVA were 0.03 ± 0.06 and 0.12 ± 0.08 logMAR, respectively. At 1 year, the mean monocular logMAR UDVA, corrected distance visual acuity, UNVA, and corrected near visual acuity were 0.10 ± 0.11, 0.02 ± 0.06, 0.18 ± 0.12, and 0.13 ± 0.08, respectively. The defocus curve and contrast sensitivity values were comparable to those obtained with other multifocal IOLs. On Scheimpflug imaging, the mean distance between the sulcus multifocal IOL and the monofocal IOL was 517 ± 141 μm. At 1 year, ultrasound biomicroscopy showed an annular fibrosis of the anterior capsule in 94.4% of the eyes. Complications included 1 posttraumatic IOL decentration and 1 slight corectopia. Eighty-nine percent of patients reported satisfaction.
The piggyback implantation of this multifocal IOL seemed to be safe and effective. It might provide similar results as a primary in-the-bag multifocal IOL, with the advantage of reversibility that might extend primary or secondary implantation.
Prospective multicenter trial of a small-aperture intraocular lens in cataract surgery
2017, Journal of Cataract and Refractive Surgery
To evaluate the clinical acceptability of monocular implantation of the small-aperture (IC-8) intraocular lens (IOL) in 1 eye and an aspheric monofocal IOL in the fellow eye of bilateral cataract patients over 6 months postoperatively.
Twelve clinics in Austria, Belgium, Germany, Italy, Spain, and Norway.
Prospective case series.
The visual acuity, depth of focus, contrast sensitivity, patient satisfaction, visual symptoms, and adverse events were assessed in patients who had bilateral cataract surgery followed by implantation of the small-aperture IOL in 1 eye and an aspheric monofocal IOL in the fellow eye. Uncorrected distance (UDVA), intermediate (UIVA), and near (UNVA) visual acuities were reported in Snellen notation.
The study comprised 105 patients. At 6 months, the UDVA, UIVA, and UNVA in eyes with the small-aperture IOL were 20/23, 20/24, and 20/30, respectively. Ninety-nine percent, 95%, and 79% of patients achieved 20/32 or better binocular UDVA, UIVA, and UNVA, respectively. Ninety-three patients (95.9%) reported they would have the procedure again versus 4 patients (4.1%) who reported they would not have the procedure again. In eyes with the small-aperture IOL, the target-corrected defocus curve measured with 0.75 diopter (D) of myopia extended the range of functional near vision by an additional diopter without loss of distance vision compared with the distance-corrected defocus curves. The mean UIVA and UNVA remained at 20/25 and 20/32, respectively, for up to 1.5 D of residual astigmatism in eyes with the small-aperture IOL.
The small-aperture IOL showed excellent visual performance, safety, patient satisfaction, and tolerance to residual astigmatism 6 months after implantation.
Visual Outcomes and Accommodative Response of the Lumina Accommodative Intraocular Lens
2016, American Journal of Ophthalmology
To compare visual acuity, accommodation, and contrast sensitivity of the AkkoLens Lumina accommodative intraocular lens (AkkoLens Clinical b.v., Breda, The Netherlands) with a standard monofocal intraocular lens (IOL).
Randomized clinical trial.
The study enrolled 86 eyes with cataract that all required cataract surgery and IOL implantation. The study group included 61 eyes that were implanted with the Lumina. The control group included 25 eyes that were implanted with an Acrysof SA60AT (Alcon, Fort Worth, TX, USA) monofocal IOL. The distance and near visual acuities, contrast sensitivity, and accommodation were measured over a 1-year follow-up period. Accommodation was measured subjectively, using defocus curves, and objectively, with an open-field autorefractor.
Uncorrected (UDVA) and corrected (CDVA) distance visual acuities did not differ significantly between the groups (P ≥ .21) over the 12 months. However, the uncorrected near visual acuity (UNVA) was 0.07 ± 0.08 logRAD for the Lumina group and 0.37 ± 0.19 logRAD for the control group (P < .01) and the corrected distance near visual acuity (CDNVA) was 0.11 ± 0.12 LogRAD for the Lumina group and 0.41 ± 0.15 LogRAD for the control group (P < .01). Defocus curves showed a statistically significant difference between groups for defocus ranging from −4.50 to −0.50 diopters (D) (P < .01) with significantly higher visual acuities for the Lumina group. Subjective accommodation, as determined from defocus curves, was 3.05 ± 1.06, 3.87 ± 1.27, and 5.59 ± 1.02 D for the Lumina group and 1.46 ± 0.54, 2.00 ± 0.52, and 3.67 ± 0.75 D for the control group at visual acuities of 0.10, 0.20, and 0.4 logMAR for both groups, respectively. The objective accommodation, measured by an open-field autorefractor, was 0.63 ± 0.41, 0.69 ± 0.45, 0.91 ± 0.51, and 1.27 ± 0.76 D for the Lumina group and 0.10 ± 0.15, 0.12 ± 0.15, −0.06 ± 0.09 and 0.07 ± 0.10 D for the control group at accommodation stimuli of 2.0, 2.5, 3.0, and 4.0 D, respectively. Contrast sensitivity was the same for both groups (P ≥ .26).
The Lumina accommodative IOL effectively restores the visual function, accommodation, and contrast sensitivity after cataract surgery with no influence on the postoperative contrast sensitivity.
Confocal laser method for quantitative evaluation of critical optical properties of toric intraocular lenses
2016, Journal of Cataract and Refractive Surgery
To present a proof-of-concept study on the development and implementation of an innovative confocal laser method platform for precise quantitative evaluation of critical optical properties unique to toric intraocular lenses (IOLs).
U.S. Food and Drug Administration, Optical Therapeutics and Medical Nanophotonics Laboratory, Silver Spring, Maryland, USA.
Experimental study.
The optical properties of hydrophobic toric IOLs were evaluated with a confocal laser method that was modified to isolate the 2 planes of focus that are observed with toric IOLs.
The results show the confocal laser method has the potential to measure the orthogonally separated optical powers and then calculate them to the commonly referenced spherical equivalent and cylinder powers of toric IOLs with high accuracy (≤1 μm of focal length measurement). Furthermore, the proposed confocal laser method design includes a new component for precise differentiation of the 2 focal planes and isolation of the 2 focal points, and thus for accurate measurement of the anterior cylinder axis of toric IOLs.
The modifications to the confocal laser method platform enabled the quantitative evaluation of optical properties attributed to toric IOLs.
None of the authors has a financial or proprietary interest in any material or method mentioned.

View all citing articles on Scopus

^☆: Supported by Allergan.

¹: Members of the AMO Array Clinical Study Group are listed in the Appendix at the end of this article.

²: Dr. Steinert is a consultant to the manufacturer of this product, Allergan, but does not have a proprietary interest. Ms. Trentacost, Ms. Smith, and Dr. Tarantino are employees of Allergan. Ms. Aker is an employee of Baxter Healthcare Corporation.

View full text

A prospective comparative study of the amo array zonal-progressive multifocal silicone intraocular lens and a monofocal intraocular lens1Historical image☆,

Abstract

Objective

Design

Participants

Methods

Main outcome measures

Results

Conclusions

Section snippets

Subject population

Results

Discussion

Ophthalmology

J Cataract Refract Surg

Am J Ophthalmol

Am J Ophthalmol

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

Ophthalmology

Am J Ophthalmol

J Cataract Refract Surg

J Cataract Refract Surg

A prospective comparative study of the amo array zonal-progressive multifocal silicone intraocular lens and a monofocal intraocular lens¹Historical image☆,