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

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.