OM t of c.iii - Vision Research Coordinating Center - Washington ...

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2/1/99 Chapter 1 Background page 1-2 The organization of the CLEK Study is outlined below (Figure 1-1) and discussed in greater detail in Chapter 16 of this Operations Manual. The CLEK Study Chairman is: • Karla Zadnik, OD PhD, The Ohio State University College of Optometry. The CLEK Executive Committee is comprised of: • Joseph T. Barr, OD MS, The Ohio State University, College of Optometry; • Timothy B. Edrington, OD MS, Southern California College of Optometry; • Donald F. Everett, MA, National Eye Institute, National Institutes of Health; • Mae O. Gordon, PhD, Washington University, Department of Ophthalmology and Visual Sciences and the Division of Biostatistics; • Timothy T. McMahon, University of Illinois at Chicago,Department of Ophthalmology and Visual Sciences; and • Karla Zadnik, OD PhD, The Ohio State University College of Optometry. The Coordinating Center is at Washington University, Department of Ophthalmology and Visual Sciences and the Division of Biostatistics, under the direction of Dr. Mae Gordon. The CLEK Photography Reading Center to evaluate photographs of contact lenses and the presence of corneal scarring is at The Ohio State University, College of Optometry, under the direction of Dr. Joseph T. Barr. The CLEK Topography Reading Center to evaluate videokeratography images and evaluate corneal topographic data is at the University of Illinois at Chicago, Department of Ophthalmology and Visual Sciences, under the direction of Dr. Timothy T. McMahon. The CLEK Participating Clinics are: • University of Alabama, Birmingham School of Optometry, under the direction of William J. Benjamin, OD, PhD • University of California at Berkeley, School of Optometry, under the direction of Nina E. Friedman, OD MS in collaboration with Kaiser Permanente, Oakland, CA, and Dennis C. Burger, OD • University Hospitals of Cleveland, University Ophthalmologists, Inc., Cleveland, OH, under the direction of Loretta Szczotka, OD • Gundersen Lutheran, LaCrosse, WI, under the direction of John Sterling, OD • University of Illinois at Chicago, Department of Ophthalmology, Chicago, IL, under the direction of Timothy T. McMahon, OD • Indiana University School of Optometry, under the direction of Gerald E. Lowther, OD PhD in collaboration with the Indianapolis Eye Care Center.
2/1/99 Chapter 1 Background page 1-3 • Jules Stein Eye Institute, UCLA, under the direction of Barry A. Weissman, OD PhD • University of Missouri St. Louis, School of Optometry, under the direction of Larry J. Davis, OD • State University of New York, State College of Optometry, under the direction of David P. Libassi, OD • Northeastern Eye Associates, Scranton, PA, under the direction of Joseph P. Shovlin, OD • NOVA Southeastern University, College of Optometry, under the direction of Heidi Wagner, OD • The Ohio State University, College of Optometry, Columbus, OH, under the direction of Barbara A. Fink, OD PhD • Pennsylvania College of Optometry, Philadelphia, PA, under the direction of Joel A. Silbert, OD • Southern California College of Optometry, Fullerton, CA, under the direction of Timothy B. Edrington, OD, MS • University of Texas, San Antonio, Health Sciences Center, Optometry Clinics • University of Utah, Department of Ophthalmology, Salt Lake City, UT, under the direction of Harald Olafsson, OD 1.1.2 Eligibility All keratoconus patients presenting to a Participating Clinic are screened for potential CLEK Study eligibility. Efforts to recruit eligible patients encompass the surrounding optometric and ophthalmologic communities. Preliminary screening for eligibility may be conducted by the referring doctor, but final eligibility is determined by the CLEK Participating Clinic. Eligible patients are enrolled in the 16 CLEK Study Participating Clinics in various eye care settings across the country. Each Participating Clinic is expected to enroll 80 patients over an eleven-month period for a total of 1,000 keratoconus patients enrolled in the study. This satisfies sample size requirements based on the criteria described in Section 2.8 of this Operations Manual. All patients are to be followed annually for at least three years for a total of at least four CLEK Study Visits. Patients requiring corneal surgery for keratoconus during the Study are seen for one additional Presurgical Visit within one month prior to their date of surgery. If the corneal surgery is scheduled within 3 months after a routine Baseline or Annual visit, then the routine visit also serves as the Presurgical Visit. They then continue their annual follow-up schedule according to the CLEK Study protocol. Eligibility is a patient-based, rather than an eye-based determination. Inclusion Criteria
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