Comparison of Air and Expansile Gas in Pneumatic Retinopexy

Study Overview
=================
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.

Official Title
-----------------
Comparison of Air and Expansile Gas in Pneumatic Retinopexy

Conditions
-----------------
Retinal Detachment

Intervention / Treatment
-----------------
* Procedure: air
* Procedure: expansile gas


Participation Criteria
=================
Eligibility 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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>air vs perfluoropropane gas in pneumatic retinopexy | Procedure: air<br>* 0.3 ml of filtered air<br>Procedure: expansile gas<br>* 0.3 ml of perfluoropropane gas<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The final visual recovery (calculated from the difference between pre-operative and post-operative visual acuity) |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
retinal detachment, pneumatic retinopexy