Air vs perfluoropropane gas in pneumatic retinopexy: a randomized noninferiority trial

Abstract

Objective: To evaluate whether air is as effective as perfluoropropane gas in treating rhegmatogenous retinal detachment by pneumatic retinopexy.

Methods: In a double-blind, randomized, clinically controlled noninferiority trial, eligible patients were randomized into 2 treatment groups by using block randomization and treated by pneumatic retinopexy using filtered air or perfluoropropane gas.

Main outcome measures: Retinal reattachment rate and final visual recovery.

Results: One hundred twenty-six patients were recruited. Half (63 patients) were assigned to receive filtered air during pneumatic retinopexy and half received perfluoropropane gas. The single-procedure reattachment rate was higher for the perfluoropropane gas group (73.0%[46 patients]) than for the air group (60.3% [38]), but the difference was not statistically significant (risk difference, -12.7%; 95% confidence interval, -29.0% to 3.6%). The final reattachment rate after additional pneumatic retinopexy and/or surgical procedures was 92.1% (58) in the air group and 96.8% (61) in the perfluoropropane gas group. This result showed an equivalent effect on the final reattachment rate (risk difference, -4.7%; 95% confidence interval, -12.7% to 3.2%). Final visual acuity did not differ significantly between groups.

Conclusion: Pneumatic retinopexy using filtered air is associated with a nonsignificantly lower initial reattachment rate than using perfluoropropane gas but results in an equivalent final reattachment rate and final visual recovery.

Application to clinical practice: Air is an acceptable alternative to perfluoropropane gas when treating rhegmatogenous retinal detachment by pneumatic retinopexy.

Trial registration: clinicaltrials.gov Identifier: NCT00120445.