Long-Term Follow-Up of Patients Enrolled in the Early Treatment Diabetic Retinopathy Study (ETDRS)
Primary Purpose
Diabetic Retinopathy
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 Retinopathy, Long-Term Visual Outcome, Photocoagulation, J. H. Wilmer Eye Institute
Eligibility Criteria
Patient was originally enrolled in the Early Treatment Diabetic Retinopathy Study at the Johns Hopkins Wilmer Eye Institute. Patient not previously enrolled are not eligible.
Sites / Locations
- National Eye Institute (NEI)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001612
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Eye Institute (NEI)
1. Study Identification
Unique Protocol Identification Number
NCT00001612
Brief Title
Long-Term Follow-Up of Patients Enrolled in the Early Treatment Diabetic Retinopathy Study (ETDRS)
Official Title
Long-Term Follow-Up of Patients Enrolled in the Early Treatment Diabetic Retinopathy Study (ETDRS)
Study Type
Observational
2. Study Status
Record Verification Date
May 1999
Overall Recruitment Status
Completed
Study Start Date
May 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2000 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Eye Institute (NEI)
4. Oversight
5. Study Description
Brief Summary
Patients enrolled in the original Early Treatment Diabetic Retinopathy Study at the Clinical Center at Johns Hopkins Wilmer Eye Institute will be invited for a follow-up visit at the National Eye Institute. Visual function will be assessed with manifest refraction and standardized visual acuity measurement. The progression of retinopathy will be evaluated by ocular exam and fundus photography. A brief medical history will be obtained. The goal of this study is to evaluate the long-term results of patients whose diabetic retinopathy was treated with different strategies of scatter and/or focal laser photocoagulation.
Detailed Description
To evaluate the long-term clinical course and prognosis of diabetic retinopathy treated with different strategies of scatter and/or focal laser photocoagulation in patients enrolled in the Early Treatment Diabetic Retinopathy Study (ETDRS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
Diabetic Retinopathy, Long-Term Visual Outcome, Photocoagulation, J. H. Wilmer Eye Institute
7. Study Design
Enrollment
170 (false)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Patient was originally enrolled in the Early Treatment Diabetic Retinopathy Study at the Johns Hopkins Wilmer Eye Institute.
Patient not previously enrolled 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
8437309
Citation
Ferris FL 3rd. How effective are treatments for diabetic retinopathy? JAMA. 1993 Mar 10;269(10):1290-1. No abstract available.
Results Reference
background
Learn more about this trial
Long-Term Follow-Up of Patients Enrolled in the Early Treatment Diabetic Retinopathy Study (ETDRS)
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