Longitudinal corneal endothelial cell loss after corrective surgery for late in-the-bag IOL dislocation: a randomized clinical trial.

Purpose: To compare safety regarding longitudinal corneal endothelial cell loss (ECL) after IOL exchange vs IOL repositioning for late in-the-bag IOL dislocation.
Setting: Oslo University Hospital, Norway.
Design: Prospective, parallel group, randomized clinical trial.
Methods: During a 3-year period, 104 patients were randomly assigned to groups receiving either IOL exchange with retropupillary fixation of an iris-claw IOL (n = 50) or IOL repositioning by scleral suturing (n = 54). All operations were performed by 1 surgeon with an anterior approach. Endothelial cell density (ECD) and central corneal thickness were measured preoperatively and at 6 months, 1 year, and 2 years postoperatively. A linear mixed model was applied for the longitudinal analysis, where patients with at least 1 ECD measurement were included (n = 44 exchange; n = 50 repositioning). The main outcome measure was 2-year longitudinal ECL in IOL exchange compared with IOL repositioning.
Results: The longitudinal ECL was similar between the IOL exchange (n = 44) and IOL repositioning (n = 50) groups during the 2 years of follow-up (17.5% vs 15.3%, P = .15). A subgroup analysis found no reason to advise against either method for patients with low preoperative ECD (<1500 cells/mm). The mean central corneal thickness was similar between the 2 groups and remained stable over 2 years of follow-up.
Conclusions: This randomized clinical trial of late in-the-bag IOL dislocation surgery found that exchanging the IOL was as safe as repositioning in terms of 2-year longitudinal ECL.