Visual Outcomes Following Cataract Surgery and Implantation of a Small-Aperture Intraocular Lens in Post-Refractive...

To evaluate visual outcomes following small-aperture intraocular lens (IOL) implantation in post-refractive surgery patients undergoing cataract surgery.

This is a prospective, single-arm, interventional study. Post-corneal refractive surgery cataract patients (N=16), desiring spectacle independence at all distances, underwent phacoemulsification, and IC-8 Apthera IOL (Bausch+Lomb) implantation in one eye with targeted postoperative manifest refraction spherical equivalent (MRSE) of -0.75 D. Study parameters were uncorrected/corrected/distance-corrected visual acuity at distance (UDVA and CDVA), intermediate (UIVA and DCIVA), and near (UNVA and DCNVA), defocus curve, and patient-reported outcomes.

At 12 months postoperatively, the mean MRSE was -0.55 ± 0.70 D in the small-aperture eyes. The mean monocular UDVA, UIVA, and UNVA were 0.05±0.06 (Snellen equivalent, 20/22.4), 0.04±0.14 (20/21.9), and 0.09±0.13 logMAR (20/24.6), and the mean monocular CDVA, DCIVA, and DCNVA were 0.02±0.05 (20/20.9), 0.03±0.12 (20/21.4) and 0.11±0.14 logMAR (20/25.7), respectively. All eyes achieved a CDVA of 20/40 or better by 1 month and maintained it until 12 months. The monocular defocus curve revealed a broad range of vision of 3.50 D at a visual acuity of 0.2 logMAR (20/31.6) or better. Over 92% (12/13) of the subjects responded that they would have the procedure done again. At 12 months postoperatively, mean patient satisfaction was 3.7 (measured on a scale of 1-5, with 1 being very dissatisfied to 5 being very satisfied) for overall vision. The incidence of mild to moderate posterior capsular opacification (PCO) was 93.8% (15/16) in the small-aperture IOL eyes and 69.2% (9/13) in the fellow eyes. All eyes with PCO (15/15) in the small-aperture IOL group required Nd:YAG capsulotomy, compared to 53.8% (7/13) of the fellow eyes.

The IC-8 Apthera small-aperture IOL provided a wide range of vision from distance to near and good spectacle independence in patients with prior corneal refractive surgery.

ClinicalTrials.gov (NCT05574270).