Clinical Trial of Cryotherapy Versus Postoperative Laser Photocoagulation
This study has been completed.
Sponsor:
University of Campinas, Brazil
Information provided by:
University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01068379
First received: February 11, 2010
Last updated: May 24, 2010
Last verified: May 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rhegmatogenous Retinal Detachment |
Procedure: criopexy Procedure: laser |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Randomized Clinical Trial of Cryotherapy Versus Postoperative Laser Photocoagulation for Retinopexy in Scleral Buckle Surgery |
Resource links provided by NLM:
Further study details as provided by University of Campinas, Brazil:
Primary Outcome Measures:
- The primary outcome was one week reattachment rate [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
| Enrollment: | 86 |
| Study Start Date: | July 2006 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cryopexy
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
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.
|
|
Experimental: laser photocoagulation 4 weeks after
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
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.
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided by University of Campinas, Brazil
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Rodrigo Pessoa Cavalcante Lira, Unicamp |
| ClinicalTrials.gov Identifier: | NCT01068379 History of Changes |
| Other Study ID Numbers: | cryo laser |
| Study First Received: | February 11, 2010 |
| Last Updated: | May 24, 2010 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by University of Campinas, Brazil:
|
rhegmatogenous retinal detachment cryopexy photocoagulation |
Additional relevant MeSH terms:
|
Retinal Detachment Retinal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 22, 2013