Anatomical and Functional Outcomes of Sutureless Scleral-Fixated Carlevale Intraocular Lens Implantation: A Retrospective Study.

Background/Objectives: The purpose of this study was evaluation of the efficacy and the rate of complication of a foldable sutureless scleral-fixated intraocular lens (SSF-IOL), named Carlevale IOL, for the treatment of aphakia without sufficient capsular support due to trauma or complicated cataract surgery. Methods: Retrospective, consecutive interventional case series. All consecutive eyes with secondary implantation of aphakic SSF-IOL were considered. The primary outcomes were as follows: best corrected visual acuity (BCVA), refractive error (RE), and intraocular pressure (IOP). Secondary outcome was the occurrence of intraoperative and postoperative complications. Results: SSF-IOL was performed in 21 eyes of 21 patients (7 men and 14 women) with mean age of 74 years (range from 36 to 90 years). The mean follow-up time was 11.4 months. VA improved significantly (p = 0.0007) from 0.38 logMAR at baseline to 0.11 logMAR at the final follow-up. BCVA improved in 18 patients, remained equal in 2 cases, and worsened in 1 case. Mean postoperative RE was -0.83 Diopters (D) (Median = -0.50 D, SD = 1.05 D) and it was less than 1D in 61.9% of patients. Mean IOP at the end of the follow-up was 15.78 mmHg (ranged from 10 to 22 mmHg, SD = 3.65). In one patient a vitreous hemorrhage was observed intraoperatively, but it resolved spontaneously. Postoperative complications included one case of cystoid macular edema and one case of epiretinal membrane. Conclusions: Carlevale SSF-IOL implantation seems to be an effective and safe procedure, ensuring good visual outcomes with a low rate of complication in eyes indicated for secondary IOL implantation.