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

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2/1/99 Chapter 2 Study Design page 2-11 since large degrees of impairment are likely to be rare. (3) The instrument needs to measure several dimensions of well-being. We considered using the CES-Depression scale in addition to the SF-36; however, results using the CES-Depression scale that were administered at the same time as the SF-36 in the CLEK pilot study showed absolutely no trend for increased risk of depression in the total score for the CES-D or in the mental health and emotional role functioning scale of the SF-36. Thus, the measurement of emotional functioning does not justify a separate instrument like the CES-D. (4) We desire a scale that could be self-administered without compromising reliability. (5) We desire an instrument with strong psychometric properties including good factor structure, high internal consistency reliability, high test-retest reliability, and good external validity. For these reasons, the Medical Outcomes Short Form with 36 items (SF-36) was selected. In addition to the SF-36 scale, a vision specific scale will be administered. The Javitt Visual Function Questionnaire (Javitt et al., 1993) was selected because the format of questions resembles the SF-36, which reduces response errors, and because it has high test-retest reliability. The National Eye Institute Visual Function Questionnaire is administered beginning in the first year of follow-up in the CLEK Study (Mangione et al., 1998). 2.5.6 First Definite Apical Clearance Lens At each CLEK Study Visit, the Clinician applies a series of CLEK Study trial lenses, beginning with the lens with base curve equal to the steep keratometric reading, until the first definite apical clearance fluorescein pattern is observed. This fluorescein pattern is photographed, as is the lens that is 0.2 mm flatter than the first definite apical clearance lens. This measurement provides an estimate of how flat or steep the patient’s current lenses are and better defines the current standard of contact lens care in the CLEK Study sample. Thus, the CLEK Photography Reading Center provides an independent, masked, standardized assessment of the habitual contact lens fit, the First Definite Apical Clearance Lens, and the 0.2 mm flatter lens throughout the course of the study. In doing so, the CLEK Photography Reading Center provides photodocumentation of the standard of contact lens care of keratoconus patients in the CLEK Study sample and an estimate of the degree of flatness (or steepness) of the habitual contact lens as compared to the first definite apical clearance lens. Additionally, the First Definite Apical Clearance Lens provides an estimate of the progression of the steepness of the apex of the cornea during the Study. 2.5.7 Surgical Intervention Corneal surgery is indicated in 10-20% of all cases of keratoconus (Kennedy et al., 1986; Smiddy et al., 1988). The need for surgery has high clinical relevance, definable
2/1/99 Chapter 2 Study Design page 2-12 costs and known risks, and evaluation of keratoconus patients as they undergo penetrating keratoplasty in terms of their visual function is important. Both the corneal surgeon and the keratoconus patient apply subjective criteria in making the surgery decision. Patients seen annually who have undergone penetrating keratoplasty in the previous year will contribute to our body of knowledge about postoperative results.
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