Aims/Purpose: The purpose of this study was to evaluate the refractive predictability of the sutureless scleral fixation Carlevale intraocular lens (IOL) for the correction of aphakia in the absence of capsular support.
Methods: Retrospective cohort study. Consecutive patients implanted with Carlevale IOL between February 2020 and February 2024, with a minimum follow-up of 3 months, were included. Exclusion criteria included use of toric IOLs and absence of postoperative refraction due to a severely limited visual acuity or lack of cooperation. The clinical data were acquired from the patients' records. Primary outcome was the postoperative spherical equivalent deviation (PSED) in relation to the preoperative refractive target. Secondary outcomes included the best corrected visual acuity (BCVA), surgically induced astigmatism (SIA), and postoperative complications.
Results: A total of 44 eyes were implanted with the Carlevale IOL in the study period. Of these, 30 met the inclusion criteria and were included in the statistical analysis. The mean follow-up time was 18.3 ± 11.7 months, and the mean age at the time of surgery was 70.93 ± 16.28 years. The most common surgical indications were aphakia after complicated cataract surgery (40%, n = 12), IOL dislocation (33.3%, n = 10), and aphakia after trauma (20%, n = 6). The PSED was -0.62 ± 1.51 diopters, with no statistically significant difference between surgical indication groups (p = 0.606). BCVA showed a statistically significant increase from 1.52 ± 0.88 to 0.42 ± 0.41 logMAR (p < 0.001). The trauma group had worse BCVA results (p = 0.013). The SIA was 1.14 ± 1.93 diopters. Regarding postoperative complications, the most common were transient ocular hypertension (20%), bleeding (hyphema or hemovitreous; 13.3%), and cystoid macular edema (6.6%).
Conclusions: The Carlevale IOL is a valuable option in our arsenal for managing aphakic eyes with no capsular support. It appears to provide acceptable predictability in refractive outcomes, with low astigmatism and few associated complications.