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 neodymium-doped yttrium aluminum garnet (Nd:YAG) capsulotomy for posterior capsule opacification (PCO) in eyes with and without pseudoexfoliation (PEX) after undergoing cataract surgery.

DESIGN

Clinical cohort study using randomized control trial data.

SUBJECTS AND CONTROLS: A total of 930 eyes with cataract and PEX without phacodonesis, clinically shallow anterior chambers, or pupil size <4 mm and 476 controls with cataract but without PEX.

METHODS

We randomized both groups separately to receive either a single-piece acrylic IOL or a 3-piece acrylic IOL. We further randomized the PEX group to receive or not receive capsular tension rings (CTRs). Experienced surgeons performed phacoemulsification with the insertion of an IOL in all eyes, and we followed all patients at 1 day, 1 month, 3 months, 1 year, and yearly thereafter for 10 years.

MAIN OUTCOME MEASURES: The association of PEX with IOL decentration, posterior capsular opacification requiring capsulotomy, and BCVA.

RESULTS

The 10-year follow-up was 82.2% for the PEX group and 85.6% for 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 = .4) and Nd:YAG capsulotomy rates (5.7% vs 5.67%, respectively, P = .98) were similar in the PEX and control groups. Capsular phimosis (P = .001) and capsulorhexis that did not overlap the edge of the IOL optic (P < .001) were risk factors for IOL decentration and Nd:YAG capsulotomy. At 10 years, logarithm of the minimum angle of resolution BCVA was better in the control group than in the PEX group (0.08 vs 0.12, respectively; P = .035). Capsular phimosis (P = .001) and a capsulorhexis that did not overlap the IOL optic (P < .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 postoperatively (most of a life expectancy), we found no differences between eyes with and without uncomplicated PEX and having a 1- or 3-piece IOL or CTRs.