The Collaborative Initial Glaucoma Treatment Study: Interim quality of life findings after initial medical or surgical treatment of glaucoma1☆
Received 26 June 2001; accepted 8 August 2001.
Abstract
Objective
To present interim quality of life (QOL) findings in the Collaborative Initial Glaucoma Treatment Study (CIGTS) using all available follow-up through 5 years from treatment initiation.
Design
Randomized controlled clinical trial.
Participants
Six hundred 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 6-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 percent of participants reporting symptoms over time. Of 43 possible symptoms, 12 symptoms were reported with greater frequency by the surgically treated group and 7 symptoms 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 observed after up to 5 years of follow-up in the CIGTS. When significant differences in visual function have been detected using the VAQ, they are 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 with 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.
Manuscript no. 210441.
aDepartment of Health Behavior and Health Education, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA
bDepartment of Ophthalmology and Visual Sciences, Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan, USA
cDepartment of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA
dDepartment of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA
eDepartment of Ophthalmology, University of Kentucky, Lexington, Kentucky, USA
Reprint requests to Nancy K. Janz, PhD, Department of Health Behavior and Health Education, School of Public Health, University of Michigan, 1420 Washington Heights, Ann Arbor, MI 48109-2029
☆ Supported by grants EY09100, EY09140, EY09141, EY09142, EY09143, EY09144, EY09145, EY09148, EY09149, EY09150, and EY09639 from the National Institutes of Health, National Eye Institute, Bethesda, Maryland.
1 Members of The CIGTS Study Group are listed in the Appendix to the accompanying article (Ophthalmology 2001;108:1941–1951).
ABSTRACT