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Sponsored by: |
National Eye Institute (NEI) |
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Information provided by: | National Eye Institute (NEI) |
ClinicalTrials.gov Identifier: | NCT00000162 |
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 | Intervention | Phase |
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Macular Degeneration Neovascularization, Pathologic Vitreous Hemorrhage |
Procedure: Macular Argon Laser Photocoagulation Procedure: Peripheral Scatter Argon Laser Photocoagulation Procedure: Scatter Argon Laser Photocoagulation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Study Start Date: | July 1977 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Patients with three types of diagnoses were accepted:
Study ID Numbers: | NEI-64 |
Study First Received: | September 23, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000162 |
Health Authority: | United States: Federal Government |
Metaplasia Eye Diseases Retinal Degeneration Macular Degeneration Neovascularization, Pathologic |
Hemorrhage Vitreous Hemorrhage Retinal Diseases Retinal degeneration |
Pathologic Processes Eye Hemorrhage |