Comparison of Air and Expansile Gas in Pneumatic Retinopexy

Phase 3

Completed

• Conditions: Retinal Detachment
• Interventions: Procedure: air; Procedure: expansile gas

• Registration Number: NCT00120445
• Lead Sponsor: Khon Kaen University

Brief Summary

The objective of the study is to evaluate the results of using air versus expansile gas (perfluoropropane) in the treatment of rhegmatogenous retinal detachment by pneumatic retinopexy, comparing the retinal reattachment rate and post-operative visual recovery.

Detailed Description

To the best of the investigators' knowledge there have been no clinical trials to compare air and expansile gas in pneumatic retinopexy. The investigators hypothesize that both air and expansile gas have the same properties of gas and remain in the eye for 5-6 days which is long enough to have moderate chorioretinal adhesion to seal the retinal break. If the investigators can prove that air is equivalent to expansile gas in this procedure, it can save a lot of money for the country. Therefore, the investigators are conducting a randomised controlled double-blind study to compare the results of using air and perfluoropropane in pneumatic retinopexy for treatment of rhegmatogenous retinal detachment.

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-07-11
• Study First Submitted QC: 2005-07-11
• Study First Posted: 2005-07-18
• Study Completion: 2007-10
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-07
• Last Update Posted: 2012-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• Superior retinal break from 8 o'clock to 4 o'clock
• Single retinal break not greater than 2.5 clock hours in size
• Multiple breaks not greater than 3 clock hours away
• No (or minimal) proliferative vitreoretinopathy
• Physically and mentally co-operated in post-operative head positioning
• Signed informed consent form for the study

Exclusion Criteria

• Ocular media opacities
• Advanced glaucoma
• Aphakia or pseudophakia
• Previous ocular surgeries
• One-eyed patients
• Subject did not sign informed consent form

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	air	air vs perfluoropropane gas in pneumatic retinopexy
2	expansile gas	air vs perfluoropropane gas in pneumatic retinopexy

Primary Outcome Measures

Name	Time	Method
The retinal reattachment rate (calculated from the number of patients who had post-operative attached retinas divided by the total number of patients treated)	1 week

Secondary Outcome Measures

Name	Time	Method
The final visual recovery (calculated from the difference between pre-operative and post-operative visual acuity)	6 weeks

Trial Locations

Locations (1)

Eye outpatients department, Srinagarind Hospital, Khon Kaen University; 🇹🇭 Khon Kaen, Thailand