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

2/2/99 Chapter 13 Chairman and Clinic Operations page 13-4
(5) The Clinic Principal Investigator sends the TMS topography data (if
applicable) on disk to the Chairman’s Office by regular mail in the CLEK
Study mailer within 24 hours.
13.6 Annual Visits
Follow-up Annual Visits are scheduled each year for eight years, using the
Baseline Visit date as the reference date (Section 5.5 of this Operations Manual).
Procedures for the Annual Visits are identical to those for the Baseline Visit (Table 13-
3).
Table 13-3. Examinations, tests and measures scheduling.
VISIT
TESTS AND MEASURES
Baseline, Annual Visits 1-8, Presurgical Visit, Re Quality of life, history, visual acuity, in rigid contact
Visit
lens wearers: current contact lens fit evaluation with
fluorescein photography, manifest refraction,
keratometry/corneal videokeratography, slit lamp
examination, corneal photography, first definite
apical clearance trial lens with fluorescein
photography of this lens and the lens 0.2 mm
flatter in rigid contact lens wearers.
13.7 Repeat Visits
Early in the CLEK Study, 100 patients (approximately 8 per Participating Clinic)
are selected at random by the Coordinating Center to participate in a study of CLEK
Study protocols and their measurement reproducibility.
Each Participating Clinic will receive notification as to which CLEK Study
patients have to be examined a second time within one month of their Baseline Visit.
These patients are called by the Clinic and scheduled for this Repeat Visit within two
weeks of notification by the Coordinating Center. These patients will undergo the
identical protocol as outlined for the Baseline Visit above.
13.8 Completion of the Patient-Completed Forms and the Medical History Portion of
the CLEK Examination Form
The CLEK Patient History form should be completed to the best of the patient’s
abilities and knowledge. It is not designed as a questionnaire where any CLEK Clinic
personnel interpret the questions or assist the patient with assessment of the questions.
The CLEK Quality of Life Form is the MOS 36-Item Short-Form Health Survey
(SF-36) and as such is a standardized instrument for the assessment of quality of life.
Patients should complete the form to the best of their abilities and knowledge, and