Long Term Follow-Up of Diabetic Retinopathy

NCT00001395 | Completed

• 2 other identifiers: 94010694-EI-0106
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blindness; Cataract; Diabetes Mellitus; Diabetic Retinopathy; Macular Degeneration

Keywords

Cataracts; Complications; Rates of Progression; Diabetic Retinopathy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Eye Institute (NEI)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Blindness; Cataract; Diabetes Mellitus; Diabetic Retinopathy; Macular Degeneration

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lens Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Retinal Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Retinal Degeneration

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: December 10, 2002
• Study Start: March 1, 1994
• Study Completion: August 1, 2000
• Last Updated: March 4, 2008

Record last verified: 1999-03

Locations

US (1)