Visual and Patient-Reported Outcomes of a Novel Full Visual Range Intraocular Lens Versus a Monofocal Intraocular Lens: A Randomized Multicenter US Trial

IF 4.2 1区医学 Q1 OPHTHALMOLOGY

American Journal of Ophthalmology Pub Date : 2025-08-29 DOI:10.1016/j.ajo.2025.08.050

MITCHELL C. SHULTZ , WILLIAM F. WILEY , EVA LIANG , ALICE T. EPITROPOULOS , JEFFREY WHITMAN

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Abstract

Purpose

To compare the visual, refractive, and patient-reported outcomes following bilateral implantation of a novel full visual range (FVR) intraocular lens (IOL) and a monofocal IOL in subjects undergoing cataract surgery.

Design

Prospective, masked, multicenter, controlled pivotal trial.

Methods

Subjects scheduled to undergo cataract surgery were randomized to bilateral implantation of a novel FVR IOL (enVista Envy MX60EF, Bausch + Lomb; N = 332) or enVista monofocal IOL (MX60E; N = 169). Primary effectiveness endpoints were monocular corrected distance visual acuity (CDVA, 4 m), distance-corrected intermediate (DCIVA, 66 cm), and near (DCNVA, 40 cm) visual acuity, and secondary effectiveness endpoints were binocular DCIVA, DCNVA, uncorrected intermediate (UIVA), and near visual acuity (UNVA), at postoperative days 120 to 180.

Results

The noninferiority of the FVR IOL group for monocular CDVA and statistical superiority for monocular DCIVA and DCNVA over the monofocal group were established. Binocular UIVA, DCIVA, UNVA, and DCNVA were also better in the FVR group compared to the monofocal group (all P < .0001). Mean postoperative MRSE was −0.14 ± 0.39 D (FVR) and −0.14 ± 0.40 D (monofocal group). The FVR group showed consistent visual acuity of ∼0.1 logMAR from −1.50 to −2.50 D. The difference in mesopic contrast sensitivity (without glare) between the 2 groups at 1.5, 3, and 12 cpds was less than the minimum detectable difference of 0.15 logCS.

Conclusions

Compared to the monofocal group, the FVR IOL group exhibited superior monocular DCNVA and DCIVA, with comparable CDVA. Binocular visual acuity was 0.09 logMAR or better (∼20/25) from distance to near (−0.5 D to −2.5 D).

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新型全视距人工晶状体与单焦点人工晶状体的视力和患者报告的结果：一项随机多中心美国试验。

目的：比较白内障手术患者双侧植入新型全视距人工晶状体和单焦点人工晶状体后的视力、屈光和患者报告的结果。设计：前瞻性、隐蔽性、多中心、对照关键试验。方法：计划接受白内障手术的受试者随机分为两组：双侧植入新型全视距（FVR）人工晶状体（enVista Envy MX60EF, Bausch + Lomb； N=332）或enVista单焦点人工晶状体（MX60E； N=169）。术后120-180天，主要疗效终点为单眼矫正距离视力（CDVA, 4 m）、距离矫正中间视力（DCIVA, 66 cm）和近视力（DCNVA, 40 cm），次要疗效终点为双眼DCIVA、DCNVA、未矫正中间视力（UIVA）和近视力（UNVA）。结果：FVR人工晶状体组单眼CDVA无劣效性，单眼DCIVA和DCNVA优于单眼组。结论：与单焦点组相比，FVR组双眼UIVA、DCIVA、UNVA和DCNVA均优于单焦点组。结论：与单焦点组相比，FVR组单眼DCNVA和DCIVA均优于单焦点组，CDVA相当。双眼视力从远到近（-0.5 D至-2.5 D）为0.09 logMAR或更好（~ 20/25）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

American Journal of Ophthalmology 医学-眼科学

CiteScore

9.20

自引率

7.10%

发文量

406

审稿时长

36 days

期刊介绍： The American Journal of Ophthalmology is a peer-reviewed, scientific publication that welcomes the submission of original, previously unpublished manuscripts directed to ophthalmologists and visual science specialists describing clinical investigations, clinical observations, and clinically relevant laboratory investigations. Published monthly since 1884, the full text of the American Journal of Ophthalmology and supplementary material are also presented online at www.AJO.com and on ScienceDirect. The American Journal of Ophthalmology publishes Full-Length Articles, Perspectives, Editorials, Correspondences, Books Reports and Announcements. Brief Reports and Case Reports are no longer published. We recommend submitting Brief Reports and Case Reports to our companion publication, the American Journal of Ophthalmology Case Reports. Manuscripts are accepted with the understanding that they have not been and will not be published elsewhere substantially in any format, and that there are no ethical problems with the content or data collection. Authors may be requested to produce the data upon which the manuscript is based and to answer expeditiously any questions about the manuscript or its authors.