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

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.