Long-Term Follow-Up of Patients Enrolled in the Early Treatment Diabetic Retinopathy Study (ETDRS) - Tabular View

Tracking Information
First Received Date ^ICMJE	November 3, 1999
Last Updated Date	March 3, 2008
Start Date ^ICMJE	May 1997
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00001612 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Long-Term Follow-Up of Patients Enrolled in the Early Treatment Diabetic Retinopathy Study (ETDRS)
Official Title ^ICMJE	Long-Term Follow-Up of Patients Enrolled in the Early Treatment Diabetic Retinopathy Study (ETDRS)
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).
Study Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE
Condition ^ICMJE	Diabetic Retinopathy
Intervention ^ICMJE
Study Arms / Comparison Groups
Publications *	Ferris FL 3rd. How effective are treatments for diabetic retinopathy? JAMA. 1993 Mar 10;269(10):1290-1. No abstract available.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	170
Completion Date	August 2000
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00001612
Responsible Party
Study ID Numbers ^ICMJE	970120, 97-EI-0120
Study Sponsor ^ICMJE	National Eye Institute (NEI)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	May 1999
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP