Retrospective Real-World Evidence Study: Performance Of A Full Range Of Vision, Toric Intraocular Lens In Patients Undergoing Cataract Surgery

This retrospective case series aims to document healthcare providers’ (HCP) real-world experience of using the enVista ENVY toric (ETN) intraocular lens (IOL), including satisfaction, IOL utilization patterns, and patient (pt) outcomes.

This sub-analysis of a multicenter, cross-sectional, retrospective case series includes case report forms (CRFs) from 10 HCPs from the USA (n=9) and Canada (n=1). Procedures were conducted between September 23, 2024, and December 30, 2024.

The ETN IOL provides up to 4 D of continuous visual range with enhanced tolerance to dysphotopsia and can treat corneal astigmatism. HCP participants completed a retrospective user-experience survey. For this sub-analysis, HCPs provided ETN electronic medical record cases using a standardized CRF to document real-world clinical performance. Key outcome measures included monocular and binocular vision outcomes (uncorrected distance visual acuity [UDVA], corrected distance visual acuity [CDVA], uncorrected intermediate visual acuity [UIVA], uncorrected near visual acuity [UNVA]), mean refractive spherical equivalent (MRSE), occurrence of glistenings, and adverse events (AEs).

This sub-analysis includes 50 pts (91 eyes): 9 unilateral pts (n=5 OD); 26% of eyes had ocular comorbidities. Mean±SD preop delta K was 1.24±0.68 (n=89); mean±SD spherical equivalent target was 0.02±0.23 (n=75).

Monocular vision outcomes: 93% 20/25 or better CDVA (n=61); 77% 20/25 or better UDVA (n=87); 94% 20/32 or better UIVA (n=49); 89% J2 or better UNVA (n=56). Binocular CDVA of 20/25 or better was achieved in 88% of pts (n=26). Mean±SD MRSE was 0.00±0.15 (n=36). No pts reported glistening. Four pts experienced AEs: epithelial defect OS; mild persistent inflammation OU; subconjunctival haemorrhage OS; one pt experienced significant corneal oedema OU and intraocular pressure spike. Posterior capsule opacification was reported in 3 eyes.

This multicentre, cross-sectional, retrospective study provides important insights into the real-world clinical performance and vision outcomes of the ETN IOL. In the cases provided, most pts achieved good distance, intermediate, and near vision, with no reported glistening and a low occurrence of reported AEs.