BACKGROUND: 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.
BACKGROUND: ClinicalTrials.gov identifier NCT06389643.

To determine the long-term anatomic outcomes and surgical complications of pars plana vitrectomy (PPV) and 4-point Gore-Tex-sutured Akreos AO60 intraocular lens (IOL) scleral fixation.
Retrospective, multicenter, multisurgeon case series.
Ninety-seven patients in tertiary eye care centers.
The patients underwent PPV and intraocular fixation of the Akreos AO60 IOL using Gore-Tex CV-8 sutures between January 2015 and April 2020. The inclusion criteria were aphakia, no capsular support, and a minimal 1 year of follow-up.
Uncorrected visual acuity (VA), complication rates or types, and refraction.
Data from 101 eyes of the 97 patients were analyzed (mean follow-up duration, 33.4 months; range, 12-62 months). The mean ± standard deviation uncorrected logarithm of the minimum angle of resolution VA improved from 1.04 ± 0.73 (20/200 Snellen equivalent) before surgery to 0.66 ± 0.65 (20/80) at 6 months after surgery (P < 0.001). The most prevalent complications included hypotony (12.9%), ocular hypertension (12.9%), corneal edema (8.9%), cystoid macular edema (6.9%), and vitreous hemorrhage (5.9%). Refraction was measured between 3 and 6 months after surgery, and 61.8% of the patients had spherical equivalent of ± 2.0 diopters. Most complications occurred in the first postoperative month and resolved spontaneously or with medical treatment.
The results demonstrated that this surgical technique is well tolerated by the eyes, with a low complication rate in the long term. The rates of IOL opacification were infrequent for up to 62 months of follow-up.