PURPOSE: To evaluate the visual and patient-reported outcomes following bilateral implantation of an enhanced monofocal intraocular lens (IOL) with higher-order aspheric coefficients and controlled curvature change.

METHODS: This non-interventional, ambispective, multicenter, single-arm study included subjects who underwent bilateral cataract surgery with enVista Aspire IOL (Bausch & Lomb) implantation (N=30). All subjects attended a single postoperative visit 60-270 days after the second eye surgery. Effectiveness assessments included photopic binocular distance-corrected visual acuity (VA) at far (CDVA), intermediate (DCIVA), distances, manifest refraction, monocular contrast sensitivity, and binocular defocus curves. Patient- reported outcomes included assessment of IOL implant symptoms (AIOLIS).

RESULTS: Postoperatively, the mean MRSE was -0.33±0.52 D. The mean binocular CDVA and DCIVA were -0.04±0.08 and 0.17±0.13 logMAR, respectively. While 86.7% of subjects had binocular DCIVA 20/32 or better. At 0.2 logMAR, the range of functional VA extended up to ~-1.25 D. Good photopic and mesopic contrast sensitivity was observed at all spatial frequencies. No serious adverse events were reported. More than 96% of subjects were not at all or a little bothered by visual disturbances, and >93% of subjects were somewhat, very, or completely satisfied with their vision.

CONCLUSION: The enVista Aspire IOL provided good binocular DCIVA while maintaining excellent CDVA and contrast sensitivity leading to high patient satisfaction