Branch Vein Occlusion Study

Sponsor
National Eye Institute (NEI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00000162
Collaborator
(none)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Macular Argon Laser Photocoagulation
  • Procedure: Peripheral Scatter Argon Laser Photocoagulation
  • Procedure: Scatter Argon Laser Photocoagulation
Phase 3

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.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Primary Purpose:
Treatment
Study Start Date :
Jul 1, 1977

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Patients with three types of diagnoses were accepted:
    1. major BVO without neovascularization;

    2. major BVO with neovascularization;

    3. 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Eye Institute (NEI)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00000162
    Other Study ID Numbers:
    • NEI-64
    First Posted:
    Sep 24, 1999
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Oct 1, 1999

    Study Results

    No Results Posted as of Jun 24, 2005