Article

Clinical and patient-reported outcomes of bilateral implantation of a +2.5 diopter multifocal intraocular lens

Maxwell, Andrew MD, PhD^*; Holland, Edward MD; Cibik, Lisa MD; Fakadej, Anna MD; Foster, Gary MD; Grosinger, Les MD; Moyes, Andrew MD; Nielsen, Stephen MD; Silverstein, Steven MD; Toyos, Melissa MD; Weinstein, Arthur MD; Hartzell, Scott MD

Author Information

From the California Eye Institute (Maxwell), Fresno, California; Cincinnati Eye Institute (Holland), Cincinnati, Ohio; Associates in Ophthalmology (Cibik), West Mifflin and the Eye Center of Central PA (Hartzell), Allenwood, Pennsylvania; Carolina Eye Associates, PA (Fakadej), Southern Pines, North Carolina; Eye Center of Northern Colorado, PC (Foster), Fort Collins, Colorado; Grosinger, Spigelman & Grey Eye Surgeons, PC (Grosinger), Bloomfield Hills, Michigan; Moyes Eye Center, PC (Moyes) and Silverstein Eye Centers (Silverstein), Kansas City, Missouri; Nielsen Eye Center (Nielsen), Quincy, Massachusetts; Toyos Clinic (Toyos), Nashville, Tennessee; Eye Associates of New Mexico (Weinstein), Albuquerque, New Mexico, USA

^*Corresponding author: Andrew Maxwell, MD, PhD, 1360 East Herndon Avenue, number 401, Fresno, California 93720, USA.

E-mail: [email protected]

Submitted May 10, 2016; revised September 14, 2016; accepted October 26, 2016.

Drs. Maxwell and Holland contributed equally to this study.

Supported by Alcon Research, Ltd., Fort Worth, Texas, USA.

Magda Michna, PhD, Aldo M. Martinez, PhD, and Val Injev, MBA, PE, Alcon Research, Ltd., assisted with manuscript preparation. Medical writing assistance was provided by Heather D. Starkey, PhD, and Natalia Zhukovskaya, PhD, Complete Healthcare Communications, LLC, Chadds Ford, Pennsylvania, and was funded by Alcon. Melissa Cable, MD, Jason Jones, MD, David Nethery, MD, and John Wood, MD, were additional study investigators.

Journal of Cataract & Refractive Surgery 43(1):p 29-41, January 2017. | DOI: 10.1016/j.jcrs.2016.10.026

Abstract

Purpose

To assess the effectiveness and safety of a multifocal intraocular lens (IOL) with +2.5 diopter (D) additional power compared with a monofocal IOL.

Setting

Fifteen sites in the United States.

Design

Prospective randomized patient- and observer-masked clinical trial.

Methods

Randomized patients received multifocal or monofocal IOLs bilaterally. Visual acuity (33 cm, 40 cm, 53 cm, 60 cm, 4 m) was measured; safety was assessed through adverse event rates. Patient-reported visual outcomes were evaluated using the Visual Tasks questionnaire. The frequency and severity of visual disturbances were evaluated using the Assessment of Photic Phenomena and Lens EffectS questionnaire.

Results

The multifocal IOL (n = 155) provided better corrected distance visual acuity at 53 cm than the monofocal IOL (n = 165) (0.322 versus 0.512 logMAR; between-group difference, −0.190 logMAR; P < .0001) and 40 cm but not at 4 m. Ocular adverse event rates were less than 3.84% in both groups. Serious adverse event rates were comparable between the 2 IOL types. Patients with multifocal IOLs reported less difficulty with near tasks (with and without correction) and intermediate tasks (without correction). Difficulty with extended-intermediate and distance tasks was similar between groups. The most frequently reported self-rated severe phenomena were halos, starbursts, and glare. Most patients (monofocal ≥72%; multifocal ≥73%) reported never experiencing blurred, distorted, or double vision.

Conclusions

The +2.5 D multifocal IOL provided better vision at 40 cm and 53 cm and similar vision at 4 m compared with the monofocal IOL. Safety profiles and visual phenomena were comparable between groups.

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Clinical and patient-reported outcomes of bilateral implantation of a +2.5 diopter multifocal intraocular lens