Sutureless Scleral-Fixated Soleko Fil Carlevale Intraocular Lens and Associated Pars Plana Vitrectomy in Aphakia Management: A National Multicenter Audit

TL;DR

This study evaluates the effectiveness and safety of a sutureless intraocular lens implant combined with vitrectomy for managing aphakia, showing good visual outcomes and manageable complications.

Contribution

The study provides a national multicenter audit of a sutureless SC-IOL implant with PPV for aphakia, offering real-world clinical outcomes and complication rates.

Findings

64.4% of patients achieved a visual acuity of ≤0.3 logMAR at 12 months.

29.8% of patients had intraocular pressure >21 mmHg at 12 months.

26.6% developed macular edema, mostly managed with topical treatment.

Abstract

Objective: The aim of this study was to evaluate the clinical outcomes of sutureless scleral-fixated (SSF) Soleko Fil Carlevale intraocular lens (SC-IOL) implants associated with pars plana vitrectomy (PPV) in patients with aphakia secondary to complicated cataract surgery or IOL luxation nationwide. Methods: A multicenter, national, retrospective study of 268 eyes (268 patients) which underwent simultaneous PPV and SC-IOL implantation was conducted. Demographics; ocular data; pre-surgical, surgical and post-surgical details; and refractive results were collected. Intra- and postoperative complications and management details were described. Best-corrected visual acuity (BCVA), intraocular pressure (IOP) and central retinal thickness (CRT) were collected at 1 week and at 1, 3, 6 and 12 months post-surgery. Kaplan–Meier curves were constructed to assess the cumulative probability of postoperative BCVA, IOP levels, macular edema (ME) and corneal decompensation. Results: The cumulative probability of final VA ≤ 0.3 logMAR was 64.4% at 12 months follow-up. The probability of IOP > 21, ≥25 and ≥30 mmHg was 29.8%, 16.9% and 10.1%, respectively, and the cumulative probability of IOP-lowering treatment was 42.3% at 12 months. Glaucoma surgery was required in 3.7% of the eyes (10/268). The cumulative probability of postoperative ME development was 26.6% at 12 months, managed with topical treatment alone (73.5%) and intravitreal injections (26.5%). Corneal transplantation was required in 3.7% of the eyes (10/268). Conclusions: Sutureless scleral-fixated SC-IOL is an adequate therapeutic alternative in the management of aphakia with good visual results and an acceptable safety profile in routine clinical care. Longer-term studies are needed to evaluate its results and complications compared to other therapeutic alternatives.

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