Completed

Photocoagulation Treatment for Diabetic Retinopathy

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What is being tested

Data Collection

Who is being recruted

Blindness+13

+ Cardiovascular Diseases

+ Diabetes Mellitus

Until 70 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: January 1972
See protocol details

Summary

Principal SponsorNational Eye Institute (NEI)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 1972

Actual date on which the first participant was enrolled.

In the 1950s, diabetic retinopathy, a complication of diabetes affecting the eyes, was a leading cause of blindness in the United States. A treatment called photocoagulation was introduced to manage this condition, but there was limited evidence of its actual benefits due to a lack of controlled clinical trials. To address this, the Diabetic Retinopathy Study (DRS) began in 1971, enrolling over 1,700 patients across 15 medical centers. This study is important as it aims to provide solid evidence on the effectiveness of photocoagulation in managing diabetic retinopathy, potentially improving care and reducing blindness for those affected by this condition. In this study, one eye of each patient is randomly chosen for immediate photocoagulation treatment, while the other eye is left untreated for comparison. The eye selected for treatment is then randomly assigned to one of two techniques, either using an argon laser or a xenon arc photocoagulator. Patients are monitored every 4 months, with their vision being carefully measured. The treatment typically involves one or two sessions and includes scatter photocoagulation, a procedure that extends to specific areas of the eye. The argon treatment involves a certain number of scatter burns and direct treatment of new vessels in specific areas, while the xenon technique involves fewer, stronger, and longer burns.

Official TitleDiabetic Retinopathy Study (DRS)
Principal SponsorNational Eye Institute (NEI)
Last updated: January 27, 2026
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.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

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.

Until 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

BlindnessCardiovascular DiseasesDiabetes MellitusDiabetic AngiopathiesDiabetic RetinopathyEndocrine System DiseasesEye DiseasesNervous System DiseasesNeurologic ManifestationsRetinal DiseasesSensation DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesVision DisordersDiabetes Complications

Criteria

Patients were eligible if they had best corrected visual acuity of 20/100 or better in each eye and the presence of proliferative diabetic retinopathy in at least one eye or severe nonproliferative retinopathy in both eyes. They could not have had prior treatment with photocoagulation or pituitary ablation, and both eyes had to be suitable for photocoagulation. All eligible patients were younger than 70 years, and the examining physician assessed the outlook for survival and availability for 5 years of followup to be good.

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 no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers
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