Interim Analysis Of A Multicentre, Retrospective, Real-World Assessment Of The Performance And Safety Of A New Enhanced Intraocular Lens In Patients Undergoing Cataract Surgery

The enVista Aspire (EA) intraocular lens (IOL; Bausch + Lomb) is indicated for the visual correction of aphakia following cataract surgery in adults. In comparison to conventional monofocal IOLs, the EA IOL utilises higher-order aspheric coefficients on their posterior surface to offer an extended depth of focus and visual range. The aim of this study was to detail real-world clinical experience with the EA IOL in patients undergoing bilateral cataract surgery.

This is an ongoing, multicentre, retrospective case series reporting real-world outcomes from centres in the USA (six surgeons) and Europe. The European cohort is an expansion of the original US protocol, and enrolment is currently ongoing.

Here we report outcomes from the US (93 eyes from 51 patients; data collection complete) and European (16 eyes from 16 patients; preliminary results from one centre) cohorts, with follow-up available up to 6 months following surgery. Clinical outcomes evaluated included postoperative manifest refractive spherical equivalent (MRSE), corrected distance visual acuity (CDVA), and uncorrected or distance-corrected intermediate visual acuity (UIVA and DCIVA, respectively). Adverse event (AE) safety monitoring was also carried out.

Preliminary analysis indicates that approximately 95% of eyes across both cohorts achieved a monocular CDVA of at least 20/25 (US: 72/75 patients; European: 16/16 patients). With regard to intermediate visual acuity, 59/82 (72%) eyes in the US cohort achieved a monocular UIVA of at least 20/32, whereas in the European cohort the mean DCIVA was 0.24±0.11 logMAR at 80 cm and 0.29±0.10 logMAR at 66 cm at 6-month follow-up. Mean postoperative MRSE was −0.16±0.41 D and −0.02±0.19 D in the US and European cohorts, respectively. Initial defocus curve analysis indicates the enhanced monofocal lens design may have modestly extended patients’ range of functional vision. To date, no patient has reported an AE.

In this ongoing real-world study, interim analysis suggests that the EA IOL can provide high refractive accuracy and excellent distance and intermediate visual acuity with a favourable safety profile in patients undergoing cataract surgery. Expanded enrolment and additional data collection are underway to further validate these findings.