Clinical Trial of Cryotherapy Versus Postoperative Laser Photocoagulation

Study Overview
=================
Brief Summary
-----------------
The purpose of this randomized clinical trial was to compare reattachment rates among patients with rhegmatogenous retinal detachment who underwent scleral buckle surgery with retinopexy by cryotherapy versus postoperative (one month) laser photocoagulation.

Detailed Description
-----------------
The purpose of this randomized clinical trial was to compare reattachment rates, visual acuity results and epiretinal membrane formation among patients with rhegmatogenous retinal detachment who underwent scleral buckle surgery with retinopexy by cryotherapy versus postoperative (one month) laser photocoagulation.

Official Title
-----------------
Randomized Clinical Trial of Cryotherapy Versus Postoperative Laser Photocoagulation for Retinopexy in Scleral Buckle Surgery

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

Intervention / Treatment
-----------------
* Procedure: criopexy
* Procedure: laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary rhegmatogenous retinal detachment with a single peripherical retinal break. All patients were phakic, under eighteen years old, with partial posterior vitreous detachment, visual loss or symptoms (floaters and photopsia) less than 30 days Exclusion Criteria: No patient had a retinal break greater than 30 degrees, or retinal detachment larger than two quadrants, history of uveitis or infectious retinopathy, presence of Proliferative vitreoretinopathy (B or C), macular disease, glaucoma, hemoglobinopathy, diabetic retinopathy, and history of trauma or previous vitreoretinal surgery.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryopexy<br>the cryopexy was performed by placement of a normal spherical probe under the bucklings, around the break. The number of cryo applications was limited in number of 3. Freezing was stopped at the beginning of retinal whitening. | Procedure: criopexy<br>* he cryopexy was performed by placement of a normal spherical probe under the bucklings, around the break. The number of cryo applications was limited in number of 3. Freezing was stopped at the beginning of retinal whitening.<br>|
| Experimental: laser photocoagulation 4 weeks after<br>Laser-retinopexy was performed after proper positioning the patients; laser energy was delivered by depressing a foot pedal. Short burn duration (0.1 seconds) and low (300-miliWatts) power settings were used initially, and both the burn duration and power were gradually increased as determined by observation. | Procedure: laser<br>* Laser-retinopexy was performed after proper positioning the patients; laser energy was delivered by depressing a foot pedal. Short burn duration (0.1 seconds) and low (300-miliWatts) power settings were used initially, and both the burn duration and power were gradually increased as determined by observation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome was one week reattachment rate |  | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rhegmatogenous retinal detachment, cryopexy, photocoagulation