Argon Laser Photocoagulation and Aspirin Treatment for Diabetic Retinopathy Management
Data Collection
Blindness+13
+ Cardiovascular Diseases
+ Diabetes Mellitus
Treatment Study
Summary
Study start date: December 1, 1979
Actual date on which the first participant was enrolled.The Early Treatment Diabetic Retinopathy Study (ETDRS) is a research study focused on evaluating the effectiveness of argon laser photocoagulation and aspirin treatment for managing diabetic retinopathy, a condition that affects the eyes of people with diabetes. This study is particularly interested in patients with nonproliferative or early proliferative diabetic retinopathy. The study involves a large group of 3,711 patients, who will be monitored for at least 4 years to gather comprehensive information on the benefits and risks of these treatments. In this study, one eye of each participant is randomly chosen for immediate photocoagulation, while the other eye is set to receive this treatment only when high-risk proliferative retinopathy develops. The study allows for additional photocoagulation during follow-ups if needed, but it's only required when the center of the macula is involved or threatened. The term 'clinically significant macular edema' is used to describe this level of severity. The study also includes aspirin therapy, based on previous observations of its potential benefits and its possible mechanisms of action. However, due to aspirin's known side effects, its use in this study is carefully controlled and monitored.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Men and women between the ages of 18 and 70 years with moderate or severe nonproliferative diabetic retinopathy or mild proliferative retinopathy in both eyes, with no previous photocoagulation treatment, and with visual acuity of 20/40 or better (20/200 or better if macular edema is present) were eligible for this study.