Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
1972-01-31
Brief Summary
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To determine whether a difference exists in the efficacy and safety of argon versus xenon photocoagulation for proliferative diabetic retinopathy.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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Xenon Photocoagulation
Argon Photocoagulation
Photocoagulation
Eligibility Criteria
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Inclusion Criteria
70 Years
ALL
No
Sponsors
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National Eye Institute (NEI)
NIH
References
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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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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NEI-62
Identifier Type: -
Identifier Source: org_study_id