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

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2/1/99 Chapter 2 Study Design page 2-23 Ware JE. Standards for validating health measures. definition and content. Journal of Chronic Diseases, 40:473-480, 1987. Williams CA, Hannush SB, Reynolds DR, and Menduke H. Reproducibility of normal corneal power measurements with a keratometer and a video keratoscope. Investigative Ophthalmolology & Visual Science 32(suppl):999, 1991. Yackels T. Factors influencing vision in keratoconus. Master’s thesis. The Ohio State University. 1991. Zadnik K, Mannis MJ, and Johnson CA. An analysis of contrast sensitivity in identical twins with keratoconus. Cornea, 3:99-103, 1984. Zadnik K, Mannis MJ, Johnson CA, and Rich D. Rapid contrast sensitivity assessment in keratoconus. American Journal of Optometry and Physiological Optics 64:693-697, 1987. Zadnik K, Friedman NE, Mutti DO, and Adams AJ. Test-retest repeatability of corneal curvature measurements. Optometry and Vision Science 69(suppl):136, 1992.
2/22/96 Chapter 3 Entry and Enrollment page 3-1 3.1 Screening for Eligibility Chapter 3 Entry and Enrollment Screening for CLEK Study eligibility is conducted on any patient who carries the working diagnosis of keratoconus or in whom keratoconus is a possible diagnosis. An Eligibility Form is completed by the Clinician on any keratoconus patient evaluated for CLEK Study eligibility at any visit to a Participating Clinic. Referring doctors can complete a draft Eligibility Form to evaluate a patient, but the Participating Clinic must complete its own Eligibility Form for submission to the Coordinating Center. This will track non-eligible patients and eligible patients who decline to participate in the CLEK Study. The Eligibility Form is forwarded to the Coordinating Center. 3.2 Implementation of Eligibility Criteria Any patient carrying a working diagnosis of keratoconus is a CLEK Study candidate. Given the relative simplicity of a preliminary screening for the entry and exclusion criteria, patients can be quickly evaluated to determine whether it is worth the Study candidate’s and the Clinic’s time to schedule the Baseline Visit. The Clinician should complete the Eligibility Form on any patient carrying the working diagnosis of keratoconus and should forward a copy of the form—whether the patient turns out to be eligible or not—to the Coordinating Center. If the patient appears eligible upon completion of the Eligibility Form, the Clinician explains the CLEK Study to the patient, requests that the patient sign an informed consent form, and schedules the patient for his or her Baseline Visit once the patient has provided informed consent. CLEK Participating Clinic personnel are informed at the beginning of the Study and at annual CLEK Study Group meetings that enrollment of an ineligible patient is a serious protocol error. The Participating Clinics will be reminded of the ramifications of enrolling a patient who is later deemed ineligible. Corrective action will be taken against Clinics who repeatedly enroll ineligible patients. 3.3 Inclusion Criteria If all of the following conditions are satisfied, the patient is eligible for the CLEK Study: • Age: At least 12 years old • Irregular corneal surface in either eye as determined by distortion of keratometric mires, of the retinoscopic reflex, or of the red reflex.
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