Abstract
INTRODUCTION: The purpose of our study was to compare the safety and efficacy of two scleral fixation intraocular lens (IOL) methods of four-point scleral fixation (Akreos AO60) and the Yamane technique (AcrySof MA60AC). METHODS: This prospective, randomized study was conducted at the Military Institute of Medicine-National Research Institute in Warsaw between 2021 and 2023. We compared both groups for cause of aphakia, ocular history, refractive status, and complication. RESULTS: Our study included 50 eyes from 47 patients. Four-point fixation was performed in 25 eyes (group 1), and the Yamane technique was used in 25 eyes (group 2). Surgical time was 24.1 min ± 8.9 in group 1 and 25.1 min ± 9.9 in group 2 (p > 0.05). The postoperative BCVA (best-corrected visual acuity) for group 1 and group 2 at 1 year's observation was 0.10 ± 0.15 and 0.09 ± 0.17 logMAR, respectively (p > 0.05). Postoperative total refractive error (RE) was - 0.06 ± 0.71 diopters (D) for four-point scleral fixation and 0.83 ± 0.70 D for Yamane technique (p < 0.05). Endothelial cell density (ECD) loss was 0.9% in group 1 and 3.5% in group 2 (p > 0.05). Bleeding into the anterior chamber and vitreous body was more frequent in the group of patients operated on with the use of the Yamane technique (10 cases, 20%, p = 0.01). IOL displacement was found in one case (2%) in group 2. CONCLUSIONS: Both analyzed techniques are well tolerated and ensure good refractive results (extremely predictable in four-point scleral fixation) and have a similar safety profile. Four-point scleral fixation of IOL would appear to be safe, effective and beneficial for young, active patients, especially after trauma or recurrent subluxation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT06389643.