Back to resultsClinical Trial of Cryotherapy Versus Postoperative Laser Photocoagulation
Primary Purpose
Rhegmatogenous Retinal Detachment
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
criopexy
laser
Sponsored by
About this trial
This is an interventional treatment trial for Rhegmatogenous Retinal Detachment focused on measuring rhegmatogenous retinal detachment, cryopexy, photocoagulation
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cryopexy
laser photocoagulation 4 weeks after
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
The primary outcome was one week reattachment rate
Secondary Outcome Measures
Full Information
NCT ID
NCT01068379
First Posted
February 11, 2010
Last Updated
May 24, 2010
Sponsor
University of Campinas, Brazil
1. Study Identification
Unique Protocol Identification Number
NCT01068379
Brief Title
Clinical Trial of Cryotherapy Versus Postoperative Laser Photocoagulation
Official Title
Randomized Clinical Trial of Cryotherapy Versus Postoperative Laser Photocoagulation for Retinopexy in Scleral Buckle Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Campinas, Brazil
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhegmatogenous Retinal Detachment
Keywords
rhegmatogenous retinal detachment, cryopexy, photocoagulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cryopexy
Arm Type
Experimental
Arm Description
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.
Arm Title
laser photocoagulation 4 weeks after
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
criopexy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
laser
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary outcome was one week reattachment rate
Time Frame
1 week
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
21149772
Citation
Lira RP, Takasaka I, Arieta CE, Nascimento MA, Caldato R, Panetta H. Cryotherapy vs laser photocoagulation in scleral buckle surgery: A randomized clinical trial. Arch Ophthalmol. 2010 Dec;128(12):1519-22. doi: 10.1001/archophthalmol.2010.271.
Results Reference
derived
Learn more about this trial
Clinical Trial of Cryotherapy Versus Postoperative Laser Photocoagulation
We'll reach out to this number within 24 hrs