Diabetic Retinopathy Study (DRS)

NCT00000160 | Completed Phase 3

• 1 other identifier: NEI-62
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Retinopathy; Blindness

Keywords

Vision Loss

Interventions

Xenon Photocoagulation PROCEDURE

Argon Photocoagulation PROCEDURE

Photocoagulation PROCEDURE

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

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

Related Publications (13)

• Diabetic retinopathy study. Report Number 6. Design, methods, and baseline results. Report Number 7. A modification of the Airlie House classification of diabetic retinopathy. Prepared by the Diabetic Retinopathy. Invest Ophthalmol Vis Sci. 1981 Jul;21(1 Pt 2):1-226. No abstract available.

  PMID: 7195893 BACKGROUND

• Four risk factors for severe visual loss in diabetic retinopathy. The third report from the Diabetic Retinopathy Study. The Diabetic Retinopathy Study Research Group. Arch Ophthalmol. 1979 Apr;97(4):654-5. doi: 10.1001/archopht.1979.01020010310003.

  PMID: 426679 BACKGROUND

• 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

  BACKGROUND

• Photocoagulation treatment of proliferative diabetic retinopathy: relationship of adverse treatment effects to retinopathy severity. Diabetic retinopathy study report no. 5. Dev Ophthalmol. 1981;2:248-61.

  PMID: 7262408 BACKGROUND

• Photocoagulation treatment of proliferative diabetic retinopathy. Clinical application of Diabetic Retinopathy Study (DRS) findings, DRS Report Number 8. The Diabetic Retinopathy Study Research Group. Ophthalmology. 1981 Jul;88(7):583-600.

  PMID: 7196564 BACKGROUND

• Ederer F, Podgor MJ. Assessing possible late treatment effects in stopping a clinical trial early: a case study. Diabetic Retinopathy Study report No. 9. Control Clin Trials. 1984 Dec;5(4):373-81. doi: 10.1016/s0197-2456(84)80016-1.

  PMID: 6394209 BACKGROUND

• Rand LI, Prud'homme GJ, Ederer F, Canner PL. Factors influencing the development of visual loss in advanced diabetic retinopathy. Diabetic Retinopathy Study (DRS) Report No. 10. Invest Ophthalmol Vis Sci. 1985 Jul;26(7):983-91.

  PMID: 2409053 BACKGROUND

• Preliminary report on effects of photocoagulation therapy. The Diabetic Retinopathy Study Research Group. Am J Ophthalmol. 1976 Apr;81(4):383-96. doi: 10.1016/0002-9394(76)90292-0.

  PMID: 944535 BACKGROUND

• Ferris FL 3rd, Podgor MJ, Davis MD. Macular edema in Diabetic Retinopathy Study patients. Diabetic Retinopathy Study Report Number 12. Ophthalmology. 1987 Jul;94(7):754-60. doi: 10.1016/s0161-6420(87)33526-2.

  PMID: 3658347 BACKGROUND

• Kaufman SC, Ferris FL 3rd, Swartz M. Intraocular pressure following panretinal photocoagulation for diabetic retinopathy. Diabetic Retinopathy Report No. 11. Arch Ophthalmol. 1987 Jun;105(6):807-9. doi: 10.1001/archopht.1987.01060060093040.

  PMID: 3555429 BACKGROUND

• Kaufman SC, Ferris FL 3rd, Seigel DG, Davis MD, DeMets DL. Factors associated with visual outcome after photocoagulation for diabetic retinopathy. Diabetic Retinopathy Study Report #13. Invest Ophthalmol Vis Sci. 1989 Jan;30(1):23-8.

  PMID: 2912911 BACKGROUND

• Indications for photocoagulation treatment of diabetic retinopathy: Diabetic Retinopathy Study Report no. 14. The Diabetic Retinopathy Study Research Group. Int Ophthalmol Clin. 1987 Winter;27(4):239-53. doi: 10.1097/00004397-198702740-00004. No abstract available.

  PMID: 2447027 BACKGROUND

• Photocoagulation treatment of proliferative diabetic retinopathy: the second report of diabetic retinopathy study findings. Ophthalmology. 1978 Jan;85(1):82-106. doi: 10.1016/s0161-6420(78)35693-1.

  PMID: 345173 BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy; Blindness; Vision Disorders

Interventions

Light Coagulation

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hemostatic Techniques; Therapeutics; Hemostasis, Surgical; Surgical Procedures, Operative; Ophthalmologic Surgical Procedures

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 23, 1999
• First Posted: September 24, 1999
• Study Start: January 1, 1972
• Last Updated: June 2, 2006

Record last verified: 2003-10