Quality Of Vision Clinical Outcomes For A New Fully Refractive Extended Depth Of Focus Intraocular Lens
Published 2024 - 42nd Congress of the ESCRS
Reference: PP22.04 | Type: Free paper | DOI: 10.82333/qkzv-wk75
Authors: Chandra Bala* 1 , Srividhya Vilupuru 2 , Linda Tsai 2 , Aixa Alarcon 2
1PersonalEYES,Sydney,Australia, 2Johnson & Johnson Surgical Vision,Irvine CA,United States
Purpose
To evaluate the visual performance of a purely refractive extended depth of focus (EDF) intraocular lens (IOL).
Setting
Sydney, Australia
Methods
A prospective, multi-center, randomized, subject/evaluator-masked study. Subjects were bilaterally implanted with the EDF test IOL (Model ZEN00V, N=60) or an enhanced monofocal control IOL (Model ICB00, N=57). Monocular corrected distance (CDVA), intermediate (DCIVA), near acuities (DCNVA) and patient reported visual symptoms were evaluated at the 6-month visit. Monocular mesopic contrast sensitivity (CS) and depth of focus (DOF) testing were assessed at 3 months.
Results
CDVA (Mean ± SD) was -0.06 ± 0.08 for test & -0.05 ± 0.08 logMAR for control . DCIVA was 0.13 ± 0.08 for test and 0.18 ± 0.14 logMAR for control (p=0.0127). DCNVA was 0.37 ± 0.10 for test & 0.43 ± 0.16 logMAR for control (p=0.0137). The test lens was statistically superior for intermediate & near. 91.7% (halos), 95.0% (starbursts) and 95.0% (glare) of test lens patients reported that they did not experience, were not bothered, or were slightly bothered by specific visual symptoms, compared to 98.2%, 100% and 96.5% in the control. The DOF range over which monocular visual acuity was 0.20 logMAR or better was -1.6 D for the test lens. Mesopic CS was comparable, falling within 0.11 log units for all measured frequencies, with & without glare.
Conclusions
The EDF IOL demonstrated extended range of vision and statistically superior intermediate and near performance compared to the monofocal IOL. Distance visual acuity, contrast sensitivity and dysphotopsia profile were similar to the monofocal IOL.