Branch Vein Occlusion Study
Primary Purpose
Macular Degeneration, Neovascularization, Pathologic, Vitreous Hemorrhage
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Macular Argon Laser Photocoagulation
Peripheral Scatter Argon Laser Photocoagulation
Scatter Argon Laser Photocoagulation
Sponsored by
About this trial
This is an interventional treatment trial for Macular Degeneration
Eligibility Criteria
Patients with three types of diagnoses were accepted: major BVO without neovascularization; major BVO with neovascularization; BVO with macular edema and reduced vision. All patients must have had onset of signs and/or symptoms of BVO less than 18 months before the initial visit, vision of 5/200 or better, and sufficient clarity of the ocular media to permit confirmation of the condition with fundus photography. Other eligibility criteria apply to each of the three major groups as well as special cases such as the occurrence of bilateral disease.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000162
First Posted
September 23, 1999
Last Updated
June 23, 2005
Sponsor
National Eye Institute (NEI)
1. Study Identification
Unique Protocol Identification Number
NCT00000162
Brief Title
Branch Vein Occlusion Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 1999
Overall Recruitment Status
Completed
Study Start Date
July 1977 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Eye Institute (NEI)
4. Oversight
5. Study Description
Brief Summary
To determine whether scatter argon laser photocoagulation can prevent the development of neovascularization.
To determine whether peripheral scatter argon laser photocoagulation can prevent vitreous hemorrhage.
To determine whether macular argon laser photocoagulation can improve visual acuity in eyes with macular edema reducing vision to 20/40 or worse.
Detailed Description
Retinal branch vein occlusion (BVO) is the second most common retinal vascular disease after diabetic retinopathy. Many treatments for this disorder were attempted before 1977, but none were proven to be effective. The only treatment that seemed at all promising in preventing visual loss from BVO was laser photocoagulation.
Approximately 500 patients were enrolled in the study. One-half were randomly assigned to treatment with argon laser photocoagulation; the other one-half remained untreated as controls. For BVO with or without neovascularization, scatter treatment of 100 to 400 laser burns was applied in the drainage area of the occluded vein site, avoiding the fovea and optic disc. Individual laser burns were 200 to 500 microns in diameter with an exposure time of 0.1 to 0.2 seconds. For macular edema, burns of 50 to 100 microns in diameter with exposure time of 0.05 to 0.1 seconds were used. A fluorescein angiogram less than 1 month old had to have been available for each patient. Treatment was performed under topical anesthesia using the argon laser to achieve a grid pattern over the area of capillary leakage identified by fluorescein in the macular region. Photocoagulation was extended no closer to the fovea than the edge of the foveal avascular zone and did not extend peripherally beyond the major vascular arcade. The efficacy of treatment was judged on the basis of visual acuity measurements as well as assessment of the subsequent development of neovascularization and/or vitreous hemorrhage. Patients were followed for at least 3 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration, Neovascularization, Pathologic, Vitreous Hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Macular Argon Laser Photocoagulation
Intervention Type
Procedure
Intervention Name(s)
Peripheral Scatter Argon Laser Photocoagulation
Intervention Type
Procedure
Intervention Name(s)
Scatter Argon Laser Photocoagulation
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients with three types of diagnoses were accepted:
major BVO without neovascularization;
major BVO with neovascularization;
BVO with macular edema and reduced vision. All patients must have had onset of signs and/or symptoms of BVO less than 18 months before the initial visit, vision of 5/200 or better, and sufficient clarity of the ocular media to permit confirmation of the condition with fundus photography. Other eligibility criteria apply to each of the three major groups as well as special cases such as the occurrence of bilateral disease.
12. IPD Sharing Statement
Citations:
PubMed Identifier
6383055
Citation
Argon laser photocoagulation for macular edema in branch vein occlusion. The Branch Vein Occlusion Study Group. Am J Ophthalmol. 1984 Sep 15;98(3):271-82. doi: 10.1016/0002-9394(84)90316-7.
Results Reference
background
PubMed Identifier
2417579
Citation
Argon laser scatter photocoagulation for prevention of neovascularization and vitreous hemorrhage in branch vein occlusion. A randomized clinical trial. Branch Vein Occlusion Study Group. Arch Ophthalmol. 1986 Jan;104(1):34-41. doi: 10.1001/archopht.1986.01050130044017.
Results Reference
background
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Branch Vein Occlusion Study
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