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

2/1/99 Chapter 4 Recruitment, Education, Consent page 4-6
Sample CLEK Study Consent Form
CLEK Study Sample Consent Form
page 1
1. STUDY TITLE: Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study
2. PERFORMANCE SITE: _______________________________
3. INVESTIGATOR: PHONE:
4. PURPOSE OF THE STUDY
This is a multi-center research study to observe how keratoconus progresses and to identify any
associations between vision and corneal changes that occur with this disorder. The Study is
sponsored by the National Eye Institute, a division of the National Institutes of Health.
Approximately 1,000 people are expected to enter the study nationwide.
5. STUDY PARTICIPANT INCLUSION CRITERIA
Persons may enter the Study if they are at least 12 years old, have a clinical diagnosis of
keratoconus (as determined by an optometrist or ophthalmologist), and are able to complete at
least 3 years of follow-up.
6. STUDY PARTICIPANT EXCLUSION CRITERIA
Persons are excluded from the study if they have had corneal transplants in both eyes, have
significant cataracts, have certain disorders of the retina or optic nerve, or have had cataract
surgery.
7. DESCRIPTION OF THE STUDY
Consecutive patients with keratoconus who satisfy the inclusion and exclusion criteria will be
asked to participate in this study. Study participants will have an eye examination when they
enter the study and yearly for eight years. Some Study participants will be asked to return for an
additional eye examination two to six weeks after entering the Study. The eye examination
includes testing of vision, checking the eyeglass prescription, measuring the curvature of the
cornea, fitting contact lenses (for diagnostic purposes only), measuring the pressure in the eye,
examining the front of the eye, and examining the back of the eye, which requires the pupil to be
dilated. Photographs of the front of the eye will be done at each visit. Routine eye care will be
done by the Study participant’s optometrist or ophthalmologist.
8. BENEFITS TO STUDY PARTICIPANTS
The benefit to Study participants is that they will receive at least four complete eye examinations
using the most modern equipment and techniques. Although there is no guarantee, the results of
the Study may benefit Study participants with regard to future management of keratoconus.