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Randomized Controlled Trial
. 2024 May;38(Suppl 1):15-20.
doi: 10.1038/s41433-024-03040-1. Epub 2024 Apr 5.

Tolerance to refractive error with a new extended depth of focus intraocular lens

Daniel A Black  1 , Chandra Bala  2 , Aixa Alarcon  3 , Srividhya Vilupuru  4
Affiliations
Randomized Controlled Trial

Tolerance to refractive error with a new extended depth of focus intraocular lens

Daniel A Black et al. Eye (Lond). 2024 May.

Erratum in

Abstract

Purpose: To evaluate the tolerance to refractive errors of a new purely refractive extended depth of focus (EDF) intraocular lens (IOL), TECNIS PureSee™ IOL, using preclinical and clinical metrics.

Methods: Preclinical evaluation included computer simulations of visual acuity (sVA) and dysphotopsia profile of different IOL designs (refractive EDF, diffractive EDF, multifocal, standard, and enhanced monofocals) using an appropriate eye model with and without ±0.50 D defocus and/or +0.75 D of astigmatism. Patients bilaterally implanted with a refractive EDF (Model ZEN00V) or an enhanced monofocal (Model ICB00) IOL from a prospective, randomized study were included. At the 6-month postoperative visit, uncorrected and corrected distance vision (UDVA and CDVA), visual symptoms, satisfaction and dependency on glasses were evaluated in a subgroup of patients with absolute residual refractive error of >0.25 D in one or both eyes.

Results: In the presence of defocus and astigmatism, sVA was comparable for all except the multifocal IOL design. The refractive EDF was more tolerant to myopic outcomes and maintained a monofocal-like dysphotopsia profile with defocus. Binocular logMAR UDVA was -0.03 ± 0.08 for ZEN00V and -0.02 ± 0.11 for ICB00. 100% ZEN00V and 97% ICB00 patients did not need glasses and were satisfied with their distance vision. Monocular CDVA, contrast sensitivity and visual symptoms were also similar between both groups.

Conclusions: The clinical outcomes of the refractive EDF IOL demonstrated high quality distance vision and dysphotopsia comparable to a monofocal IOL, even in the presence of refractive error, thus matching the design expectations of the EDF IOL.

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Conflict of interest statement

DAB: Consultant to, and performs research supported by, Johnson and Johnson Surgical Vision, Inc. CB: Consultant to, and performs research supported by, Johnson and Johnson Surgical Vision, Inc and Alcon. AA: Employee of Johnson & Johnson Surgical Vision, Inc. SV: Employee of Johnson & Johnson Surgical Vision, Inc.

Figures

Fig. 1
Fig. 1
Percentage of eyes that achieved 0.10 logMAR or better monocular uncorrected simulated visual acuity (sVA). Results for test (ZEN00V) and control (ICB00) IOLs, and additional TECNIS platform IOL designs (ZCB00, ZXROO and ZLB00).
Fig. 2
Fig. 2. Dysphotopsia profile simulations from −0.5 D to +0.5 D of defocus simulated for a 5 mm pupil aperture with test (ZEN00V) and control (ICB00) IOLs, and additional TECNIS platform IOL designs (ZCB00, ZXROO and ZLB00).
The vertical line illustrates the distance focus (0 D).
Fig. 3
Fig. 3
Percentage of patients with absolute SEQ of >0.25 D in one or both eyes achieving binocular uncorrected distance visual acuity (UDVA) of 0.0, 0.1 and 0.2 logMAR. Results for ZEN00V (test) and ICB00 (control) groups at 6 months.
Fig. 4
Fig. 4. Mean monocular, distance corrected contrast sensitivity under mesopic lighting conditions without glare (left graph), and with glare (right graph) at the 3-month postoperative visit for ZEN00V and ICB00 first implanted eyes.
Error bars represent ± standard deviation. Some data were not available from one site due to measurement error.
See this image and copyright information in PMC

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