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Sponsored by: |
National Eye Institute (NEI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00001395 |
The efficacy of laser photocoagulation treatment for diabetic retinopathy has been demonstrated by several National Eye Institute (NEI) sponsored clinical trials. The Diabetic Retinopathy Study (DRS) demonstrated that scatter photocoagulation reduces the risk of blindness from diabetic retinopathy. The Early Treatment Diabetic Retinopathy Study (ETDRS) extended these findings by providing information on when to initiate scatter photocoagulation and by demonstrating that focal treatment was effective in treating macula edema. The Krypton Argon Regression Neovascularization Study (KARNS) showed that scatter photocoagulation with krypton red laser was just as safe and effective as the argon blue-green laser in the treatment of proliferative diabetic retinopathy.
Unfortunately, there is little data on the long term effects of photocoagulation on visual function. The first objective of this study is to assess the long term effects of photocoagulation for diabetic retinopathy. A second objective is to provide additional information on the risk of progression of cataracts in persons with diabetes. All patients previously treated with laser photocoagulation (focal and/or scatter) are eligible to participate in this long term study. The first priority will be given to patients who participated in the ETDRS and KARNS because of the wealth of information available regarding the details of their treatment and course after treatment. Study evaluations will include a standard ophthalmic examination, fluorescein angiography, lens and fundus photography.
Condition |
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Blindness Cataract Diabetes Mellitus Diabetic Retinopathy Macular Degeneration |
Study Type: | Observational |
Official Title: | Long Term Follow-Up of Diabetic Retinopathy |
Estimated Enrollment: | 75 |
Study Start Date: | March 1994 |
Estimated Study Completion Date: | August 2000 |
The efficacy of laser photocoagulation treatment for diabetic retinopathy has been demonstrated by several National Eye Institute (NEI) sponsored clinical trials. The Diabetic Retinopathy Study (DRS) demonstrated that scatter photocoagulation reduces the risk of blindness from diabetic retinopathy. The Early Treatment Diabetic Retinopathy Study (ETDRS) extended these findings by providing information on when to initiate scatter photocoagulation and by demonstrating that focal treatment was effective in treating macula edema. The Krypton Argon Regression Neovascularization Study (KARNS) showed that scatter photocoagulation with krypton red laser was just as safe and effective as the argon blue-green laser in the treatment of proliferative diabetic retinopathy.
Unfortunately, there is little data on the long term effects of photocoagulation on visual function. The first objective of this study is to assess the long term effects of photocoagulation for diabetic retinopathy. A second objective is to provide additional information on the risk of progression of cataracts in persons with diabetes. All patients previously treated with laser photocoagulation (focal and/or scatter) are eligible to participate in this long term study. The first priority will be given to patients who participated in the ETDRS and KARNS because of the wealth of information available regarding the details of their treatment and course after treatment. Study evaluations will include a standard ophthalmic examination, fluorescein angiography, lens and fundus photography.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
All patients with diabetic retinopathy that has been treated previously with laser photocoagulation, either focal or scatter treatment, are eligible.
Patients must be 18 or more years of age.
Patients who have not had laser photocoagulation for diabetic retinopathy are not eligible for the study.
Study ID Numbers: | 940106, 94-EI-0106 |
Study First Received: | November 3, 1999 |
Last Updated: | March 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00001395 |
Health Authority: | United States: Federal Government |
Cataracts Complications Rates of Progression Diabetic Retinopathy |
Sensation Disorders Vision Disorders Metabolic Diseases Eye Diseases Diabetes Mellitus Disease Progression Vascular Diseases Retinal Degeneration Macular Degeneration Endocrine System Diseases Lens Diseases Blindness |
Diabetic Angiopathies Signs and Symptoms Diabetic Retinopathy Cataract Neurologic Manifestations Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Diabetes Complications Retinal Diseases Retinal degeneration |
Nervous System Diseases Cardiovascular Diseases |