Comparison of Safety and Efficacy of Four-Point Scleral Intraocular Lens Fixation and the Yamane Technique

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.