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.

Condition	Intervention	Phase
Retinal Detachment	Procedure: air  Procedure: expansile gas	Phase III

Further Study Details: 

Primary Outcomes: The retinal reattachment rate (calculated from the number of patients who had post-operative attached retinas divided by the total number of patients treated)
Secondary Outcomes: The final visual recovery (calculated from the difference between pre-operative and post-operative visual acuity)
Expected Total Enrollment:  126

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.

Genders Eligible for Study:  Both

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00120445

Yosanan Yospaiboon, M.D.      +6643-348383    yosanan@kku.ac.th
Pantipa Wongwai, M.D.      +6643-348383 

Thailand
      Eye outpatients department, Srinagarind Hospital, Khon Kaen University, Khon Kaen,  40002,  Thailand; Recruiting

Study chairs or principal investigators

Yosanan Yospaiboon, M.D.,  Principal Investigator,  Khon Kaen University   

Study ID Numbers:  HE470116; TRF470116
Record last reviewed:  July 2005
Last Updated:  July 18, 2005
Record first received:  July 15, 2005
ClinicalTrials.gov Identifier:  NCT00120445
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research
ClinicalTrials.gov processed this record on 2005-07-26