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

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2/1/99 Chapter 1 Background page 1-4 If all of the following conditions are satisfied, the patient is eligible for the study: • Age: At least 12 years old • Irregular corneal surface in either eye determined by distortion of keratometric mires, of the retinoscopic reflex, or of the red reflex. • Either Vogt’s striae in the deep stroma or Fleischer’s ring of at least 2 mm of arc or corneal scarring characteristic of keratoconus in either eye. • Able to complete at least 3 years of follow-up. Exclusion Criteria If a patient has the following s/he is excluded from the CLEK Study: • Bilateral corneal transplants • Non-keratoconic ocular disease in both eyes: cataract, intraocular lens implant, macular disease, optic nerve disease other than glaucoma (eg, optic neuritis, optic atrophy) 1.1.3 CLEK Participating Clinic Structure Each CLEK Participating Clinic is reimbursed in the Study on a “capitated” basis. Reimbursement for any given visit is contingent on the Coordinating Center’s and the CLEK Photography Reading Center’s reports of quality data from that visit. Clinics are reimbursed on a graduated scale: $100 for the patient’s first visit, $125 for the second visit, and $150 each for the third and fourth visits. Extra visits as mandated by the Coordinating Center (Repeat Visits for reproducibility purposes) or when a patient requires a Presurgical Visit are reimbursed at the rate of $150 each. CLEK Study patients are directly reimbursed $20 from the Chairman’s Office for their expenses for each CLEK Study Visit. Each Participating Clinic has at least two people trained and CLEK Studycertified to perform each of the key CLEK Study tasks. Each Participating Clinic may assign these tasks to a Clinician, a Technician and/or a Photographer (Table 1-1). All Participating Clinic staff must participate in the centralized CLEK Study training and certification meeting prior to patient enrollment. Site visits are performed by members of the Executive Committee and the Coordinating Center for quality assurance in the first year of the Study and every other year thereafter and on an as-needed basis (eg, if a Participating Clinic is generating consistently poor data or poor quality photographs, if there are extensive personnel changes at a Participating Clinic, or if a new Participating Clinic joins the CLEK Study).
2/1/99 Chapter 1 Background page 1-5 Table 1-1. CLEK Study Key Tasks Requiring Study Certification. Task Who Can Be Certified to Perform Task Visual acuity (high and low contrast Bai Clinician, Technician* Lovie visual acuity) Refraction Clinician, Technician* Slit lamp examination Clinician Contact lens fit assessment, First Definit Clinician Apical Clearance Lens Corneal photography Clinician, Photographer Fluorescein photography Clinician, Photographer Keratometry (all Clinics) and topograph Clinician, Technician*, Photographer* Study Coordination Clinician, Technician, Photographer *A Technician is permitted to perform these measurements on CLEK Study patients if appropriately trained and Study-certified and if it is legal in that Clinic’s state for a Technician to perform these measurements. Note: CLEK Study personnel can utilize a “Recorder” to transcribe Study data as long as the Recorder is certified in at least one key task of the CLEK Study. 1.1.4 Fluorescein Photography Fluorescein photography is performed as follows: • On CLEK Study patients who wear rigid contact lenses to document the fluorescein pattern of the patient’s habitual contact lenses. • On all CLEK Study patients, to document the flattest lens from the CLEK Study trial lens set that shows apical clearance (the First Definite Apical Clearance Lens) and the CLEK Study trial lens with base curve 0.2 mm flatter than the First Definite Apical Clearance Lens. Fluorescein photography film is sent to the CPRC for processing and grading. Standardized grading of these photographs by the CLEK Photography Reading Center provides information on corneal curvature and disease progression and on how contact lenses are fitted on CLEK Study patients. 1.1.5 Visual Acuity Measurement Visual acuity is measured by the Clinician or the Technician. The procedure for measuring visual acuity was originally developed for the Early Treatment of Diabetic Retinopathy Study (ETDRS) using Bailey-Lovie high contrast visual acuity charts. The following visual acuity measurements are conducted at each CLEK Study Visit: (1) High and low contrast Bailey-Lovie visual acuity with habitual correction, for each eye
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