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

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).