The Extended Depth Of Focus Performance Of An Aspheric Intraocular Lens With A Modified Optic Design
Published 2026 - 44th Congress of the ESCRS
Reference: POCAT342 | Type: Free paper | DOI: 10.82333/w6v3-jw94
Authors: Dr Robert Edward Ang* 1 , Dr Kalayaan Bilbao 2 , Dr Alvin Relucio 2
1Refractive Surgery,Asian Eye Institute,Makati,Philippines, 2Medical Affairs,Hoya Surgical Optics,Irvine,United States
Purpose
To evaluate the clinical performance of an aspheric Intraocular Lens (IOL) with a modified optic design (XY1-EM) and to assess its qualification as an extended depth of focus (EDF) IOL using established American National Standards Institute ( ANSI) and International Organization for Standardization (ISO) performance standards.
Setting
Pooled analysis of two contemporaneous, multinational, multicenter, prospective clinical trials with similar age groups, observation periods, and trial conditions.
Methods
Retrospective comparison of consolidated 12-month data from two prospective clinical trials assessing visual and refractive outcomes of eyes that received XY1-EM or its monofocal parent lens XY1. Study endpoints were benchmarked against ANSI and ISO criteria for EDF IOLs: 1) test IOL corrected distance visual acuity (CDVA) noninferior to control at 0.1 logMAR level; 2) test IOL distance-corrected intermediate visual acuity (DCIVA) ≤0.2 logMAR at 66 cm; 3) test IOL DCIVA superior to control at 66 cm; 4) test IOL negative defocus range at the 0.2 logMAR threshold ≥ 0.5 D greater than control; and 5) test IOL distance-corrected visual acuity (DCVA) at 1.0 m ≤0.2 logMAR.
Results
XY1-EM demonstrated non-inferior DCVA, significantly improved DCIVA, and a ≥0.5 D greater negative defocus range compared with XY1. 1) 12-month postoperative mean monocular CDVA in XY1-EM eyes was -0.01 ± 0.07 logMAR compared to 0.04 ± 0.10 in XY1 eyes, demonstrating non-inferiority with a margin of 0.10 logMAR. 2, 3) Mean DCIVA in XY1-EM eyes was 0.15 ± 0.14 logMAR vs. 0.26 ± 0.13 logMAR in XY1 eyes (p < 0.0001). 4) Monocular negative defocus range at the 0.20 logMAR threshold was 0.57 diopters (D) greater with XY1-EM vs. XY1: XY1-EM intersected the threshold at -1.45 D, XY1 at -0.88 D. 5) Mean defocus VA at -1.0 D was 0.178 ± 0.108 logMAR for XY1-EM.
Conclusions
The Vivinex Impress IOL (XY1-EM), when compared to its parent monofocal lens, Vivinex XY1, demonstrated a clinically meaningful extension of depth of focus and met all ANSI and ISO criteria for classification as an EDF IOL.