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Long Term Follow-Up of Diabetic Retinopathy
This study has been completed.
Sponsored by: National Eye Institute (NEI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001395
  Purpose

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
Blindness
Cataract
Diabetes Mellitus
Diabetic Retinopathy
Macular Degeneration

Genetics Home Reference related topics: X-linked juvenile retinoschisis
MedlinePlus related topics: Cataract Diabetes Diabetic Eye Problems Macular Degeneration Retinal Disorders
U.S. FDA Resources
Study Type: Observational
Official Title: Long Term Follow-Up of Diabetic Retinopathy

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 75
Study Start Date: March 1994
Estimated Study Completion Date: August 2000
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001395

Locations
United States, Maryland
National Eye Institute (NEI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

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

Keywords provided by National Institutes of Health Clinical Center (CC):
Cataracts
Complications
Rates of Progression
Diabetic Retinopathy

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009