The Purpose of this grant is to fund the Statistical Coordinating Center for the Prospective Evaluation of Radial Keratotomy (PERK) study to examine the patients at ten years after surgery. Radial keratotomy is the most frequently done refractive corneal surgical procedure; approximately 150,000 cases are being done annually in the United States and hundreds of thousands more worldwide. It is important to document the efficacy, safety. stability. and predictability of the procedure over the long-term. The rationale and specific research questions of this study are given in the application for the Clinical Coordinating Center. The Statistical Coordinating Center will be responsible for the following tasks to prepare for and carry out the collection. analysis, and interpretation of the 10 year followup data: (1) maintain current PERK study data; (2) maintain patient information data for tracking and contacting PERK patients; (3) collaborate in the development of the protocol for the 10-year examination; (4) prepare for the training of data coordinators for the nine clinical centers; (5) develop and test data collection forms and procedures; (6) enter, verify. edit and update the data from the clinical centers; (7) prepare reports on clinical performance and patient status; (8) prepare presentations and manuscripts of the study results; (9) plan and carry out the closeout of the clinical centers; (10) if warranted. based on the results of the 10 year examination, make initial preparations for a subsequent 15 year examination of the patients in the PERK study.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10EY003752-13
Application #
3559108
Study Section
Vision Research and Training Committee (VSN)
Project Start
1980-09-30
Project End
1996-02-29
Budget Start
1993-03-01
Budget End
1994-02-28
Support Year
13
Fiscal Year
1993
Total Cost
Indirect Cost
Name
Emory University
Department
Type
Schools of Medicine
DUNS #
042250712
City
Atlanta
State
GA
Country
United States
Zip Code
30322