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Clinical Trials
October 11, 2010

Air vs Perfluoropropane Gas in Pneumatic Retinopexy: A Randomized Noninferiority Trial

Author Affiliations

ANNE S.LINDBLADPhDAuthor Affiliations: Department of Ophthalmology, Faculty of Medicine (Drs Sinawat, Ratanapakorn, Sanguansak, and Yospaiboon), Srinagarind Hospital (Ms Prompol), and Department of Biostatistics and Demography, Faculty of Public Health (Dr Laopaiboon), Khon Kaen University, Khon Kaen, Thailand.

Arch Ophthalmol. 2010;128(10):1243-1247. doi:10.1001/archophthalmol.2010.230

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