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

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2/1/99 CLEK OM Table of Contents page 8 16.9.3 Rationale for Approval Requirement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-11 16.9.4 Preparation of Approval Request for Ancillary Study . . . . . . . . . . . . . . . . 16-11 16.9.5 Procedures for Obtaining Ancillary Study Approval . . . . . . . . . . . . . . . . . 16-12 16.9.6 Funding of Ancillary Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-12 16.9.7 Publication of Ancillary Study Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-12 16.9.8 Progress Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-12 16.10 Access to Study Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-13 16.10.1 Study Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-13 16.10.2 CLEK Study Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-13 PAGE
2/1/99 Chapter 1 Background page 1-1 Chapter 1 Background 1.1 CLEK Study Synopsis The Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study is a multi-center, observational study designed to describe the course of this chronic ocular disease and to describe the associations among its visual and physiological manifestations. One thousand keratoconus patients are enrolled at 16 Participating Clinics over the course of 10 months. Patients will be examined annually for at least three years. Examinations include visual acuity, patient-reported visual quality of life, manifest refraction, keratometry, photodocumentation of the cornea to identify central corneal scarring, photodocumentation of the flattest contact lens from the CLEK Study trial set to achieve apical clearance, and slit lamp biomicroscopy. In rigid contact lens wearers, the fluorescein pattern of the patient’s habitual contact lenses is photodocumented. The CLEK Study characterizes keratoconus over the course of the disease both by initially enrolling patients at various disease stages and by following these patients for at least three years. The goal is to characterize the disease across its course and to identify risk factors and protective factors that determine the severity and progression of the disease. 1.1.1 CLEK Study Organization Figure 1-1. CLEK Study Organization. National Eye Institute DMOC Executive Committee Coordinating Center Chairman's Office CPRC CTRC Participating Clinics
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OM t of c.iii - Vision Research Coordinating Center - Washington ...

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