Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000160
Status:
COMPLETED
Last Update Posted:
2006-06-02
First Post:
1999-09-23
Brief Title:
Diabetic Retinopathy Study DRS
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2003-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
To determine whether a difference exists in the efficacy and safety of argon versus xenon photocoagulation for proliferative diabetic retinopathy
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 1700 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 1600 500-micron scatter burns of 01 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
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 1600 500-micron scatter burns of 01 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None