Document Detail


Air vs perfluoropropane gas in pneumatic retinopexy: a randomized noninferiority trial.
MedLine Citation:
PMID:  20937993     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Archives of ophthalmology     Volume:  128     ISSN:  1538-3601     ISO Abbreviation:  Arch. Ophthalmol.     Publication Date:  2010 Oct 
Date Detail:
Created Date:  2010-10-12     Completed Date:  2010-10-27     Revised Date:  2011-09-21    
Medline Journal Info:
Nlm Unique ID:  7706534     Medline TA:  Arch Ophthalmol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1243-7     Citation Subset:  AIM; IM    
Affiliation:
Department of Ophthalmology, Faculty of Medicine, Khon Kaen University, Muang District, Khon Kaen 40002, Thailand.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00120445
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MeSH Terms
Descriptor/Qualifier:
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
Chemical
Reg. No./Substance:
0/Fluorocarbons; 76-19-7/perflutren
Comments/Corrections
Comment In:
Arch Ophthalmol. 2011 Aug;129(8):1110-1; author reply 1111   [PMID:  21825210 ]
Arch Ophthalmol. 2011 Aug;129(8):1109-10; author reply 1110   [PMID:  21825208 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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