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.

• Authors: Suthasinee Sinawat, Tanapat Ratanapakorn, Thuss Sanguansak, Sirinada Prompol, Malinee Laopaiboon, Yosanan Yospaiboon
• Journal: Archives of ophthalmology (Chicago, Ill. : 1960) (Arch Ophthalmol) Vol. 128 Issue 10 Pg. 1243-7 (Oct 2010) ISSN: 1538-3601 [Electronic] United States
• PMID: 20937993 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Fluorocarbons
• perflutren

Topics

• Adolescent
• Adult
• Aged
• Air
• Double-Blind Method
• Female
• Fluorocarbons (administration & dosage)
• Humans
• Injections
• Intraoperative Complications
• Male
• Middle Aged
• Ophthalmologic Surgical Procedures
• Postoperative Complications
• Retinal Detachment (physiopathology, surgery)
• Treatment Outcome
• Visual Acuity (physiology)
• Young Adult