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

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2/1/99 Chapter 1 Background page 1-6 separately and both eyes together; (2) High and low contrast Bailey-Lovie visual acuity with best correction (for rigid contact lens wearers (including Softperm and piggyback wearers): contact lenses with optimal over-refraction, for non-rigid contact lens wearers: a CLEK Study Trial Lens Set contact lens with base curve equal to steep “K” plus optimal over-refraction), for each eye separately; and (3) High contrast Bailey-Lovie visual acuity with manifest refraction, for each eye separately. 1.1.6 Keratometry Central keratometric readings are determined at each CLEK Study Visit. In addition, at all Participating Clinics with TMS devices, corneal topographic video images are obtained at each Study Visit, stored on diskette, and shipped to the Chairman’s Office for storage and future analysis. At Clinics without TMS devices, videokeratographic data are collected and stored on-site at the Clinic. 1.1.7 Slit Lamp Biomicroscopy A thorough slit lamp biomicroscopic examination is performed at each CLEK Study Visit. Corneal findings, including Vogt’s striae, Fleischer’s ring, corneal scarring, and corneal staining are carefully recorded. 1.1.8 Corneal Photography Corneal photography is performed at each CLEK Study Visit. The corneal photography protocol is performed following pupillary dilation and includes two photographs in oblique, diffuse illumination and four parallelepiped photographs of the apical cornea. The film is sent to the CPRC for processing. Photographs are read by the CLEK Photography Reading Center. The results of the readings are sent to the Coordinating Center. 1.1.9 Quality of Life Our pilot studies demonstrate the importance of measuring quality of life in the CLEK Study. Results from the Medical Outcomes Study Short Form (SF-36) are available for 29 of the 30 keratoconus patients who were randomized in the CLEK pilot study comparing two contact lens fitting strategies. Despite the fact that all respondents rated their general health as “Good,” Very Good,” or “Excellent,” and despite the fact that they reported almost no impairment in the performance of physical role functions, 69% of the patients reported experiencing “bodily pain” in the past four weeks (31% very mild, 14% mild, 24% moderate), and 34% reported that this pain interfered with their normal work (22% a little bit, 7% moderately, 4% quite a bit). This finding is striking given the fact that these patients appear “healthy” and functional in almost every other respect. The measurement of quality of life in this sample will provide
2/1/99 Chapter 1 Background page 1-7 information on role limitations that cannot be inferred from other clinical measures. Several instruments for measuring quality of life were considered, including the Sickness Impact Profile and the Index of Well-Being, in addition to the Medical Outcomes Study Short Form (MOS SF-36). Furthermore, specific depression scales like the Beck Depression Scale and the Community Epidemiological Study Depression Scale (CES-D) were considered because of the widely held belief that keratoconus patients are at higher risk of depression and anxiety. (Mannis et al., 1987; Swartz et al., 1990; Besançon et al., 1980). We selected the MOS SF-36 and decided against the inclusion of an instrument specific to depression. There are several reasons for these two decisions. (1) Keratoconus is a chronic disease that does not severely compromise health status, although keratoconus might result in impaired social and physical role functioning. Results from the CLEK pilot study suggest that instruments that focus only on activities of daily living that reflect physical functioning are insensitive to the role impairment associated with keratoconus. The results from the CLEK pilot study demonstrate the utility of assessing “role functioning” independently from “activities of daily living.” (2) The instrument needs to be sensitive to small degrees of impairment 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, the vision specific scale will be administered. Vision specific scales developed by the following investigators were reviewed: (1) Haase and Bryant (1973); (2) Bernth-Peterson (1981); (3) Javitt et al. (1993); (4) Mangione et al. (1992); (5) Sloane et al. (1992). The Javitt Visual Function Questionnaire (Javitt, 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). 1.2 Specific Aims of the Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study This multi-center observational study, the Collaborative Longitudinal Evaluation
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