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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
National Eye Institute (NEI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 23, 1999
    Last Updated
    June 23, 2005
    Sponsor
    National Eye Institute (NEI)
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    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
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    Branch Vein Occlusion Study

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