Summary
PURPOSE: To assess clinical performance and outcomes of the enVista ASPIRE (EA) and EA Toric (ETA) enhanced monofocal intraocular lenses (IOLs) in real-world practice.
METHODS: This multicenter, retrospective, case review analyzed standardized case report forms from six US-based ophthalmologists with ≥3 years’ experience in cataract surgery using monofocal and/or toric IOLs. Each ophthalmologist contributed ≥5 cases of EA/ETA implantation following cataract extraction. Outcomes included monocular vision (Snellen; corrected distance visual acuity [CDVA], uncorrected distance visual acuity [UDVA], uncorrected intermediate visual acuity [UIVA]), refractive outcomes, and safety at ≤3 months post-surgery.
RESULTS: This analysis included 88 eyes (54 patients) implanted with EA and 53 eyes (35 patients) implanted with ETA. Mean±SD spherical equivalent (SEQ) target was −0.08±0.16 for EA and −0.04±0.17 for ETA. In eyes implanted with EA and ETA, respectively, monocular outcomes were CDVA ≤20/25 in 97.2% (70/72) and 94.9% (37/39), UDVA ≤20/25 in 71.3% (62/87) and 84.9% (45/53), and UIVA ≤20/32 in 76.6% (59/77) and 93.0% (40/43). Mean±SD SEQ outcome for EA and ETA, respectively, was −0.06±0.30 (n=79) and 0.00±0.32 (n=48) and residual cylinder was −0.48±0.67 (n=78) and −0.34±0.33 (n=48). Blurred vision was the most commonly reported visual change in 5.7% and 7.5% of eyes with EA and ETA, respectively; one EA patient underwent a YAG laser capsulotomy (OU). No other adverse events (AEs) were reported.
CONCLUSIONS: EA and ETA achieved good distance and functional intermediate vision for most patients following cataract surgery, with minimal residual refractive error and no serious AEs reported.