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CompletedNCT00000162Updated Jun 24, 2005

Branch Vein Occlusion Study

A Phase 3 interventional study of Macular Argon Laser Photocoagulation and Peripheral Scatter Argon Laser Photocoagulation in Macular Degeneration, Neovascularization, Pathologic and Vitreous Hemorrhage, sponsored by National Eye Institute (NEI). Completed. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by National Eye Institute (NEI) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Macular Degeneration
  • Neovascularization, Pathologic
  • Vitreous Hemorrhage
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

Browse Macular Degeneration studies →

Lead sponsor

National Eye Institute (NEI) is the lead sponsor of 266 studies on the registry; 17 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized

Interventions

  • ProcedureMacular Argon Laser Photocoagulation
  • ProcedurePeripheral Scatter Argon Laser Photocoagulation
  • ProcedureScatter Argon Laser Photocoagulation
06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 6383055 ↗
  • 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. PubMed 2417579 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00000162
Lead sponsor
National Eye Institute (NEI)
First posted
Sep 24, 1999
Start date
Jul 1977
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 1999. You cannot join it, but the record below documents what was studied.

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