Trial reportClinical ophthalmology (Auckland, N.Z.)2026
Visual Outcomes Following Cataract Surgery and Implantation of a Small-Aperture Intraocular Lens in Post-Refractive Surgery Patients.
Trial report in Clinical ophthalmology (Auckland, N.Z.), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05574270 (Clinical Investigation of a Small Aperture Extended Depth of Focus Intraocular Lens in Patients With Complex Corneas), which is not on this map. Not yet cited in PubMed.
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Clinical Investigation of a Small Aperture Extended Depth of Focus Intraocular Lens in Patients With Complex Corneas
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Abstract
Purpose: To evaluate visual outcomes following small-aperture intraocular lens (IOL) implantation in post-refractive surgery patients undergoing cataract surgery. Patients and Methods: 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. Results: 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. Conclusion: 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. Trial Registration: ClinicalTrials.gov (NCT05574270).
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