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Trial: NCT00000162 [RDF]

Label NCT00000162
Slug nct00000162
Trialid NCT00000162
Lookup name NCT00000162
Provenance http://clinicaltrials.gov/show/NCT00000162?displayxml=true
Lastchanged date June 23, 2005
Firstreceived results date
Firstreceived date September 23, 1999
Id info nct id NCT00000162
Overall status Completed
Id info secondary id
Biospec retention
Required header link text Link to the current ClinicalTrials.gov record.
Enrollment
Number of arms
Is section 801
Is fda regulated
Brief title Branch Vein Occlusion Study
Acronym
Official title
Study type Interventional
Id info nct alias
Completion date
Verification date October 1999
Why stopped
Id info org study id NEI-64
Required header url https://clinicaltrials.gov/show/NCT00000162
Study design
Source National Eye Institute (NEI)
Primary completion date
Brief summary
Number of groups
Required header download date ClinicalTrials.gov processed this data on April 18, 2017
Phase Phase 3
Start date July 1977
Has expanded access No
Biospec descr
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.
Condition browse None
Intervention browse None
Responsible party None
Overall contact None
Overall contact backup None
Sponsor group None
Oversight info None
Eligibility None
Keywords None
Conditions Macular Degeneration, Neovascularization, Pathologic, Vitreous Hemorrhage
Locations None
Links None
Results references None
Arm groups None
Location countries None
Interventions Macular Argon Laser Photocoagulation (Intervention), Scatter Argon Laser Photocoagulation (Intervention), Peripheral Scatter Argon Laser Photocoagulation (Intervention)
Secondary outcomes None
References None
Primary outcomes None
Removed countries None
Overall officials None