Ferrer Alapont, LorenaBernal Morales, CarolinaNavarro, Manuel J.Ruiz Casas, DiegoGarcía Arumí, ClaudiaCubero Parra, Juan ManuelDabad Moreno, José VicenteVelázquez Villoria, DanielMarticorena Salinero, JoaquínZarco Bosquet, JuliánArmadá Maresca, FélixIrigoyen Laborra, CristinaSantamaría Álvarez, Juan FranciscoCarnota Méndez, PabloSánchez Santos, IdairaOlivier Pascual, NuriaAscaso Puyuelo, Francisco JavierZarranz Ventura, JavierSutureless Scleral Fixated-Soleko Fil Carlevale-IOL Spanish Study Group2025-07-162025-07-162025-06-042077-0383https://hdl.handle.net/2445/222284Objective: 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.14 p.application/pdfengcc-by (c) Ferrer Alapont, Lorena et al., 2025http://creativecommons.org/licenses/by/3.0/es/Lents intraocularsCirurgia de cataractesIntraocular lensesCataract surgerySutureless scleral-fixated soleko fil carlevale intraocular lens and associated pars plana vitrectomy in aphakia management: a national multicenter auditinfo:eu-repo/semantics/article2025-07-15info:eu-repo/semantics/openAccess40507725