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

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2/1/99 Chapter 4 Recruitment, Education, Consent page 4-5 4.7 Sample Informed Consent Form A generic Informed Consent Form for use by the CLEK Clinics to obtain their institution’s Human Subjects approval follows.
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.
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OM t of c.iii - Vision Research Coordinating Center - Washington ...

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