Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000162
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-09-23
Brief Title:
Branch Vein Occlusion Study
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1999-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 2040 or worse
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 2040 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 01 to 02 seconds For macular edema burns of 50 to 100 microns in diameter with exposure time of 005 to 01 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 andor vitreous hemorrhage Patients were followed for at least 3 years
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 01 to 02 seconds For macular edema burns of 50 to 100 microns in diameter with exposure time of 005 to 01 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 andor vitreous hemorrhage Patients were followed for at least 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None