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OBJECTIVE: To present interim quality of life (QOL) findings in the collaborative initial glaucoma treatment study (CIGTS) using all available follow-up through five years from treatment initiation. DESIGN: Randomized, controlled clinical trial. PARTICIPANTS: Six hundred and seven newly diagnosed patients with open-angle glaucoma from 14 clinical centers. INTERVENTION: Patients were randomly assigned to either initial medical therapy or initial trabeculectomy. After treatment initiation and early follow-up, patients received clinical and QOL evaluations at six-month intervals. QOL assessments were administered by telephone at a centralized interviewing center. MAIN OUTCOME MEASURES: The CIGTS collected comprehensive QOL information that included both generic and vision-specific QOL measures. This article focuses on initial treatment group differences related to symptom reporting, as measured by a symptom and health problem checklist, and changes in daily visual functioning, as measured by the visual activities questionnaire (VAQ). RESULTS: Across both treatment groups, there was an overall decline in the percentage of participants reporting symptoms over time. Of 43 possible symptoms, 12 were reported with greater frequency by the surgically-treated group and seven more frequently by the medically-treated group. The surgical patients reported more total symptom impact glaucoma (p = 0.005) and, in particular, more bother related to local eye symptoms. Very few treatment group differences were noted in visual functioning, although surgical patients reported more problems with activities related to their visual acuity (p = 0.024). The percentage of patients across treatment groups reporting worry about blindness was 50% at baseline, but declined to approximately 25% over time. CONCLUSIONS: Overall, the QOL impact reported by the two treatment groups, as measured by instruments used in this study, is remarkably similar, with relatively few significant study group differences being observed after up to five years of follow-up in the CIGTS. When significant differences in visual function were detected using the VAQ, they were consistent with the clinical outcomes. To date, the most persistent QOL finding is the increased impact of local eye symptoms reported by the surgical group compared to the medical group. Although no changes are recommended in the treatment of newly diagnosed glaucoma patients at the time of this interim report, further follow-up will allow for more definitive answers to the QOL impact of these two treatment approaches.
Dr N.K. Janz, Department of Health Behavior and Health Education, School of Public Health, University of Michigan, 1420 Washington Heights, Ann Arbor, MI 48109-2029, USA
1.4 Quality of life (Part of: 1 General aspects)