Clinical Comparison of a Small-Aperture Intraocular Lens Versus a Monofocal Control.

Purpose: To evaluate range of visual acuity, visual quality, and safety of the IC-8 small-aperture (SA) intraocular lens (IOL) (Apthera; Bausch & Lomb, Inc) in patients with cataract.

Methods: This was a prospective, multicenter, open-label, parallel-group, non-randomized, examiner-masked, 12-month clinical study conducted at 21 sites in the United States. Included patients (N = 453) received either the SA IOL (targeted to -0.75 diopters) in one eye and a monofocal or monofocal toric IOL (targeted to plano) in the fellow eye (SA IOL group, n = 343) or bilateral monofocal/monofocal toric IOLs (control group, n = 110).

Results: At 6 months, the SA IOL group achieved superior binocular uncorrected intermediate and near visual acuity (P < .0001) and equivalent binocular uncorrected distance visual acuity versus the control group. In SA IOL eyes, 99.1% achieved monocular corrected distance visual acuity of 0.3 logarithm of the minimum angle of resolution or better. The SA IOL and control groups had comparable binocular photopic and mesopic contrast sensitivities at 6 months both with and without glare. The SA IOL group reported few visual symptoms overall, although at higher rates than in the control group.

Conclusions: The SA IOL group exhibited improved intermediate and near vision, comparable distance vision and binocular contrast sensitivities, and few visual symptoms or adverse events versus the bilateral monofocal/monofocal toric IOL group, suggesting that the SA IOL is an effective option for presbyopia correction at the time of cataract surgery. [J Refract Surg. 2024;40(11):e824-e835.].