Krypton-Argon Regression of Neovascularization Study (KARNS)

NCT00000153 | Completed Phase 3

• 1 other identifier: NEI-55
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate whether red krypton laser treatment is as effective at causing regression of diabetic disc neovascularization as treatment with the blue-green argon laser, when both lasers are used with identical panretinal photocoagulation patterns. To assess the vision of study patients. To test the feasibility of a prototype NEI-sponsored multicenter clinical trial in which participating clinics are not financially reimbursed and in which both the Coordinating and Fundus Photograph Reading Center functions are carried out by staff of the NEI Biometry and Epidemiology Program.

Conditions

Diabetic Retinopathy; Retinal Neovascularization; Diabetes Mellitus

Keywords

Diabetic Disc Neovascularization; Optic Disk

Interventions

Blue-Green Argon Laser Treatment PROCEDURE

Red Krypton Laser Treatment PROCEDURE

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Men and women ages 18 through 79 diagnosed with diabetes mellitus and who had neovascularization on the optic nerve head (NVD) were eligible. NVD in one or both eyes of each patient had to be greater than or equal to DRS Standard Photograph 10A. NVD was defined as new vessels on the surface of the retina, further forward in the vitreous cavity over the disc, or within one disc diameter of the disc in any direction. Patient's ocular media must have been clear enough for fundus photography, which allowed the extent of neovascularization on the optic nerve head to be assessed. (If vitreous hemorrhage or other media opacity prevented adequate visualization of the neovascularization, it would greatly impair the ability to assess the effect of photocoagulation.) Another requirement for patient eligibility was the presence of an area of at least three quadrants of the retina in which full argon or krypton laser panretinal photocoagulation could be placed. (Vitreous hemorrhage and/or traction retinal detachment that interfered with treatment was less than one quadrant in extent.)

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 (4)

• Ferris FL; Ferris FL; Ferris FL; Singerman LJ; Inexpensive collaborative research., Invest Ophthalmol Vis Sci 24 (suppl) 1983

  BACKGROUND

• Davis MD; Singerman LJ; Ferris FL III; Passloff RW; Red krypton laser (RKL) versus blue-green argon laser (BGAL) treatment of proliferative diabetic retinopathy (PDR) with neovascularization of the disc (NVD)., Invest Ophthalmol Vis Sci 24 (suppl) 1983

  BACKGROUND

• Randomized comparison of krypton versus argon scatter photocoagulation for diabetic disc neovascularization. The Krypton Argon Regression Neovascularization Study report number 1. Ophthalmology. 1993 Nov;100(11):1655-64. doi: 10.1016/s0161-6420(93)31421-1.

  PMID: 8233391 BACKGROUND

• Mancia G, Schumacher H, Bohm M, Redon J, Schmieder RE, Verdecchia P, Sleight P, Teo K, Yusuf S. Relative and Combined Prognostic Importance of On-Treatment Mean and Visit-to-Visit Blood Pressure Variability in ONTARGET and TRANSCEND Patients. Hypertension. 2017 Nov;70(5):938-948. doi: 10.1161/HYPERTENSIONAHA.117.09714. Epub 2017 Oct 3.

  PMID: 28974567 DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy; Retinal Neovascularization; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Endocrine System Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

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: December 1, 1984
• Last Updated: June 24, 2005

Record last verified: 1999-10