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Diabetic Retinopathy Study (DRS)

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ClinicalTrials.gov Identifier: NCT00000160
Recruitment Status : Completed
First Posted : September 24, 1999
Last Update Posted : June 2, 2006
Sponsor:
Information provided by:
National Eye Institute (NEI)

Brief Summary:

To determine whether photocoagulation helps prevent severe visual loss from proliferative diabetic retinopathy.

To determine whether a difference exists in the efficacy and safety of argon versus xenon photocoagulation for proliferative diabetic retinopathy.


Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Blindness Procedure: Xenon Photocoagulation Procedure: Argon Photocoagulation Procedure: Photocoagulation Phase 3

Detailed Description:

By the 1950s, diabetic retinopathy had become a leading cause of blindness and visual disability in the United States. The use of photocoagulation to treat proliferative retinopathy gained widespread use in ophthalmic practice following its introduction in 1959. However, only a few studies of photocoagulation incorporated any of the basic principles of controlled clinical trials, and these involved inadequate numbers of patients. Consequently, there has been inadequate evidence of the actual value of the procedure. Because of the clinical importance of diabetic retinopathy and the increasing use of photocoagulation in its management, the Diabetic Retinopathy Study (DRS) was begun in 1971. This randomized, controlled clinical trial involved more than 1,700 patients enrolled at 15 medical centers.

One eye of each patient was randomly assigned to immediate photocoagulation and the other to followup without treatment, regardless of the course followed by either eye. The eye chosen for photocoagulation was randomly assigned to either of two treatment techniques, one using an argon laser and the other a xenon arc photocoagulator. Patients were followed at 4-month intervals according to a protocol that provided for measurement of best corrected visual acuity.

Treatment was usually completed in one or two sittings and included scatter (panretinal) photocoagulation extending to or beyond the vortex vein ampulae. The argon treatment technique specified 800 to 1,600, 500-micron scatter burns of 0.1 second duration and direct treatment of new vessels whether on or within one disc diameter of the optic disc (NVD) or outside this area (NVE). Focal treatment was also applied to microaneurysms or other lesions thought to be causing macular edema. Followup treatment was applied as needed at 4-month intervals. The xenon technique was similar, but scatter burns were fewer in number, generally of longer duration, and stronger, and direct treatment was applied only to NVE on the surface of the retina.


Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : January 1972

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U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Additional Information:
Publications:
The Diabetic Retinopathy Study Research Group; Photocoagulation treatment of proliferative diabetic retinopathy: A short report of long range results., Diabetic Retinopathy Study (DRS) Report Number 4. Proceedings of the 10th Congress of the International Diabetes Federation 1979
The Diabetic Retinopathy Study Research Group; Photocoagulation treatment of proliferative diabetic reinopathy: The second report from the Diabetic Retinopathy Study, Arch Ophthalmol 1978;85:81-106

ClinicalTrials.gov Identifier: NCT00000160     History of Changes
Other Study ID Numbers: NEI-62
First Posted: September 24, 1999    Key Record Dates
Last Update Posted: June 2, 2006
Last Verified: October 2003

Keywords provided by National Eye Institute (NEI):
Vision Loss

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Blindness
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms