Comparison of Air and Expansile Gas in Pneumatic Retinopexy

Khon Kaen University

Status and phase: Completed; Phase 3

Conditions: Retinal Detachment

Treatments: Procedure: air; Procedure: expansile gas

Study type: Interventional

Funder types: Other

Identifiers

NCT00120445

TRF470116 (Other Grant/Funding Number)

HE470116

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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126 participants in 1 patient group

2

Active Comparator group

Description:

air vs perfluoropropane gas in pneumatic retinopexy

Treatment:

Procedure: air

Procedure: expansile gas