Diabetic Retinopathy and Visual Function Study
Primary Purpose
Diabetic Retinopathy, Macular Degeneration, Vision, Subnormal
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Diabetic Retinopathy focused on measuring Diabetic Macular Edema, Diabetic Retinopathy, Macular Edema, Photocoagulation, Psychophysical Testing, Stiles-Crawford Effect
Eligibility Criteria
Patients with diabetic retinopathy that has not been previously treated are eligible for the study. Patients who have had laser photocoagulation (either focal or scatter) are not eligible.
Sites / Locations
- National Eye Institute (NEI)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001346
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Eye Institute (NEI)
1. Study Identification
Unique Protocol Identification Number
NCT00001346
Brief Title
Diabetic Retinopathy and Visual Function Study
Official Title
Diabetic Retinopathy and Visual Function Study
Study Type
Observational
2. Study Status
Record Verification Date
February 2000
Overall Recruitment Status
Completed
Study Start Date
November 1992 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2000 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Eye Institute (NEI)
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate possible mechanisms of central visual loss in patients with diabetes mellitus. The visual loss of interest to be investigated is that associated with macular edema (prior to and following laser photocoagulation treatment) and that associated with panretinal photocoagulation. The evaluation will be performed with psychophysical testing, i.e., static perimetry and contrast sensitivity function. Of particular interest, the mechanisms of visual loss associated with macular edema (prior to and following laser photocoagulation) will be further investigated. Photoreceptor-mediated visual loss will be assessed by measurements of the Stiles-Crawford effect. Visual loss mediated by post-receptoral retinal changes will be assessed by measuring the Westheimer spatial desensitization/sensitization effect.
Detailed Description
The purpose of this study is to evaluate possible mechanisms of central visual loss in patients with diabetes mellitus. The visual loss of interest to be investigated is that associated with macular edema (prior to and following laser photocoagulation treatment) and that associated with panretinal photocoagulation. The evaluation will be performed with psychophysical testing, i.e., static perimetry and contrast sensitivity function. Of particular interest, the mechanisms of visual loss associated with macular edema (prior to and following laser photocoagulation) will be further investigated. Photoreceptor-mediated visual loss will be assessed by measurements of the Stiles-Crawford effect. Visual loss mediated by post-receptoral retinal changes will be assessed by measuring the Westheimer spatial desensitization/sensitization effect.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Macular Degeneration, Vision, Subnormal
Keywords
Diabetic Macular Edema, Diabetic Retinopathy, Macular Edema, Photocoagulation, Psychophysical Testing, Stiles-Crawford Effect
7. Study Design
Enrollment
100 (false)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients with diabetic retinopathy that has not been previously treated are eligible for the study.
Patients who have had laser photocoagulation (either focal or scatter) are not eligible.
Facility Information:
Facility Name
National Eye Institute (NEI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
3729795
Citation
Higgins KE, Meyers SM, Jaffe MJ, Roy MS, de Monasterio FM. Temporary loss of foveal contrast sensitivity associated with panretinal photocoagulation. Arch Ophthalmol. 1986 Jul;104(7):997-1003. doi: 10.1001/archopht.1986.01050190055039.
Results Reference
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PubMed Identifier
6367724
Citation
Klein R, Klein BE, Moss SE, Davis MD, DeMets DL. The Wisconsin epidemiologic study of diabetic retinopathy. II. Prevalence and risk of diabetic retinopathy when age at diagnosis is less than 30 years. Arch Ophthalmol. 1984 Apr;102(4):520-6. doi: 10.1001/archopht.1984.01040030398010.
Results Reference
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PubMed Identifier
6367725
Citation
Klein R, Klein BE, Moss SE, Davis MD, DeMets DL. The Wisconsin epidemiologic study of diabetic retinopathy. III. Prevalence and risk of diabetic retinopathy when age at diagnosis is 30 or more years. Arch Ophthalmol. 1984 Apr;102(4):527-32. doi: 10.1001/archopht.1984.01040030405011.
Results Reference
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Diabetic Retinopathy and Visual Function Study
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