Aravind Pseudoexfoliation Study (APEX): 10 Year Postoperative Results.

PURPOSE To compare long-term (10-year) best corrected visual acuity (BCVA) and complication rates of intraocular lens (IOL) decentration and Nd:YAG capsulotomy for posterior capsule opacification (PCO) in eyes with and without pseudoexfoliation (PEX) after undergoing cataract surgery. DESIGN Clinical cohort study using RCT data. SUBJECTS AND CONTROLS Nine hundred thirty eyes with cataract and pseudoexfoliation without phacodonesis, clinically shallow anterior chambers, or pupil size <4 mm and 476 controls with cataract but without pseudoexfoliation. METHODS We randomized both groups separately to receive either a single-piece acrylic IOL or a 3-piece acrylic IOL. We further randomized the pseudoexfoliation group to receive or not receive capsular tension rings. We performed phacoemulsification using experienced surgeons with the insertion of an (IOL) on all eyes and we followed all at 1 day, 1 month, 3 months, 1 year, and yearly thereafter for 10 years. MAIN OUTCOME MEASURES The association of pseudoexfoliation with IOL decentration, posterior capsular opacification requiring capsulotomy, and best corrected visual acuity. RESULTS The 10-year follow-up was 82.2% for the PEX group and 85.6% in the control group excluding those who died in the interim. 24.1% and 16.8% respectively died before completion. IOL decentration rates (2.4% vs 1.7%, respectively, p=0.4) and Nd:YAG capsulotomy rates (5.7% vs 5.67%, respectively, p=0.98) were similar in PEX and control groups. Capsular phimosis (p=0.001) and capsulorhexis that did not overlap the edge of the IOL optic (p<0.001) were risk factors for IOL decentration and Nd:YAG capsulotomy. At 10 years, logMAR BCVA was better in the control than the PEX group (0.08 vs 0.12 respectively; p=0.035). Capsular phimosis (p=0.001) and a capsulorhexis that did not overlap the IOLs optic (p<0.001) were each independently associated with decentration and need for a capsulotomy. CONCLUSIONS This is the only long-term large-scale prospective comparative study using experienced surgeons evaluating both CTRs and IOL types in eyes with PEX, without preoperative and intraoperative zonular weakness and small pupils. At 10 years post-operative (most of a life expectancy) we found no differences between eyes with and without uncomplicated PEX and having either 1- or 3-piece IOLs, or CTRs.