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

2/1/99 Chapter 2 Study Design page 2-13
2.5.8 Other Measures
Other measures are outlined on the CLEK Study Forms. A case history is taken
by the Clinician that includes family history, systemic and ocular disease history,
contact lens wearing time, and contact lens comfort. Additional procedures included as
part of routine, annual ophthalmic care are a dilated fundus exam and applanation
tonometry. See Chapter 7 of this Operations Manual for detailed information on these
techniques.
No additional tests or measures can be made on CLEK Study patients without
prior approval by the Executive Committee and/or the Data Monitoring and Oversight
Committee. Similarly, CLEK Study patients cannot be enrolled in other eye studies after
enrollment in CLEK without prior approval of the Executive Committee and the
DMOC.
2.6 Issues of Recruitment and Retention
Each Clinic is responsible for recruitment of patients. Recruitment depends on
referral patterns within the community, on other doctors’ willingness to refer patients,
and on the type of CLEK Study marketing appropriate for the community. CLEK Study
meetings are an important forum for sharing successful recruitment and retention
strategies.
Although the CLEK Executive Committee believes that keratoconus patients are
likely to be interested in participating in the study, patients are reimbursed a nominal
amount for each visit to offset such expenses as transportation, parking, and child care.
This reimbursement is processed by the Chairman’s Office, thereby facilitating a
centralized, annual CLEK Study patient address update.
Health maintenance organizations (HMOs) are expected to be an excellent source
of potential enrollees for the Study. In fact, one of the HMOs participating in the
screening study screened the largest number of potential subjects. However, HMOs are
not likely to refer patients to the Study if additional costs are incurred. Each Clinic
contacts local HMOs and makes appropriate arrangements.
2.7 Routine Ophthalmic Care and Emergencies
Each CLEK Study patient receives all his or her routine, non-Study related care
from his or her Participating Clinic and/or referring doctor. Usual and customary fees
for these services and ophthalmic materials will apply and are unaffected by CLEK
Study participation.
In the event that an enrolled CLEK Study patient goes on to corneal surgery, an
extra study examination is conducted within one month before surgery. The patient is
scheduled according to his original date of enrollment for postsurgical CLEK Study