Completed

Long Term Follow-Up of Diabetic Retinopathy

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Who is being recruted

Cardiovascular Diseases+20

+ Diabetic Angiopathies

+ Endocrine System Diseases

See all eligibility criteria
How is the trial designed

Observational
Study Start: March 1994
See protocol details

Summary

Principal SponsorNational Eye Institute (NEI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 1994

Actual date on which the first participant was enrolled.

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.

NCT00001395
Principal SponsorNational Eye Institute (NEI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

75 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesDiabetic AngiopathiesEndocrine System DiseasesEye DiseasesLens DiseasesMetabolic DiseasesNervous System DiseasesNeurologic ManifestationsNutritional and Metabolic DiseasesRetinal DegenerationRetinal DiseasesSensation DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesVision DisordersGlucose Metabolism DisordersDiabetes ComplicationsBlindnessCataractDiabetes MellitusDiabetic RetinopathyMacular Degeneration

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Eye Institute (NEI)

Bethesda, United StatesOpen National Eye Institute (NEI) in Google Maps
CompletedOne Study Center