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2/1/99 Chapter 5 Scheduling page 5-1
5.1 Introduction
Chapter 5
Scheduling of Patient’s Visits, Tests, and Measures
This chapter discusses: scheduling and timing of examinations, tests, and
measures.
Table 5-1 illustrates the time windows for each visit. Forms needed for each type
of CLEK Study Visit are listed in Table 5-2. All of the examinations, tests, and measures
listed in Table 5-3 are conducted at each CLEK Study Visit.
5.2 Eligibility
The Clinician completes an Eligibility Form for ALL patients who are
keratoconus suspects or previously diagnosed as having keratoconus.
If the patient is eligible, the Clinician explains the CLEK Study to the patient and
requests informed consent or has the patient return after considering informed consent
(Chapter 4, “Patient Education, Informed Consent, and Patient Recruitment”).
Table 5-1. Timing for visit scheduling.
VISIT
Baseline
Annual Visit 1
Annual Visit 2
Annual Visit 3
Annual Visit 4
Annual Visit 5
Annual Visit 6
Annual Visit 7
Annual Visit 8
Repeat Visit
TARGET DATE
As soon as eligibility is determined and informed
consent is obtained.
12 months from Baseline date ± 1 month
24 months from Baseline date ± 1 month
36 months from Baseline date ± 1 month
48 months from Baseline date ± 1 month
60 months from Baseline date ± 1 month
72 months from Baseline date ± 1 month
84 months from Baseline date ± 1 month
96 months from Baseline date ± 1 month
Within one month of a Baseline visit as instructed by
the Coordinating Center
Note: The target dates are a goal. However, it is very important that enrolled CLEK
Study patients be followed no matter what. Thus, longer intervals between visits are
preferable to missed visits.