Diabetes Mellitus Clinical Trial
NCT number | NCT00000153 |
Other study ID # | NEI-55 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | September 23, 1999 |
Last updated | June 23, 2005 |
Start date | December 1984 |
Verified date | October 1999 |
Source | National Eye Institute (NEI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
To evaluate whether red krypton laser treatment is as effective at causing regression of
diabetic disc neovascularization as treatment with the blue-green argon laser, when both
lasers are used with identical panretinal photocoagulation patterns.
To assess the vision of study patients.
To test the feasibility of a prototype NEI-sponsored multicenter clinical trial in which
participating clinics are not financially reimbursed and in which both the Coordinating and
Fundus Photograph Reading Center functions are carried out by staff of the NEI Biometry and
Epidemiology Program.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 79 Years |
Eligibility | Men and women ages 18 through 79 diagnosed with diabetes mellitus and who had neovascularization on the optic nerve head (NVD) were eligible. NVD in one or both eyes of each patient had to be greater than or equal to DRS Standard Photograph 10A. NVD was defined as new vessels on the surface of the retina, further forward in the vitreous cavity over the disc, or within one disc diameter of the disc in any direction. Patient's ocular media must have been clear enough for fundus photography, which allowed the extent of neovascularization on the optic nerve head to be assessed. (If vitreous hemorrhage or other media opacity prevented adequate visualization of the neovascularization, it would greatly impair the ability to assess the effect of photocoagulation.) Another requirement for patient eligibility was the presence of an area of at least three quadrants of the retina in which full argon or krypton laser panretinal photocoagulation could be placed. (Vitreous hemorrhage and/or traction retinal detachment that interfered with treatment was less than one quadrant in extent.) |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Eye Institute (NEI) |
Davis MD; Singerman LJ; Ferris FL III; Passloff RW; Red krypton laser (RKL) versus blue-green argon laser (BGAL) treatment of proliferative diabetic retinopathy (PDR) with neovascularization of the disc (NVD)., Invest Ophthalmol Vis Sci 24 (suppl) 1983
Ferris FL; Ferris FL; Ferris FL; Singerman LJ; Inexpensive collaborative research., Invest Ophthalmol Vis Sci 24 (suppl) 1983
Randomized comparison of krypton versus argon scatter photocoagulation for diabetic disc neovascularization. The Krypton Argon Regression Neovascularization Study report number 1. Ophthalmology. 1993 Nov;100(11):1655-64. — View Citation
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