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Abstract #18386 Published in IGR 3-3
Interim clinical outcomes in the collaborative initial glaucoma treatment study comparing initial treatment randomized to medications or surgery
Lichter PR; Musch DC; Gillespie BW; Guire KE; Janz NK; Wren PA; Mills RP; CIGTS Study GroupOphthalmology 2001; 108: 1943-1953
PURPOSE: To report interim outcome data, using all available follow-up through five years after treatment initiation, in the collaborative initial glaucoma treatment study (CIGTS). DESIGN: Randomized clinical trial. PARTICIPANTS: Six hundred and seven newly diagnosed glaucoma patients. METHODS: In a randomized clinical trial, 607 patients with newly diagnosed open-angle glaucoma were initially treated with either medication or trabeculectomy (with or without 5-fluorouracil). After treatment onset and early follow-up, patients were evaluated clinically at six-month intervals. In addition, quality of life telephone interviews were conducted at a similar frequency to the clinical visits. Patients in both arms of CIGTS were treated aggressively in an effort to reduce intraocular pressure (IOP) to a level at or below a predetermined target pressure specific for each individual eye. Visual field (VF) scores were analyzed by time-specific comparisons and by repeated measures models. MAIN OUTCOME MEASURES: VF loss was the primary outcome variable in CIGTS. Secondary outcomes of visual acuity (VA), IOP, and cataract were also studied. RESULTS: On the basis of completed follow-up through four years and partially complete through five years, VF loss did not differ significantly by initial treatment. Over the entire period of follow-up, surgical patients had a greater risk of substantial VA loss compared with medical patients. However, by four years after treatment, the average VA in the two groups was about equal. Over the course of follow-up, IOP in the medicine group averaged 17-18 mmHg, whereas that in the surgery group averaged 14-15 mmHg. The rate of cataract requiring removal was greater in the surgically treated group. CONCLUSIONS: Both initial medical or initial surgical therapy resulted in about the same VF outcome after up to five years of follow-up. VA loss was greater in the surgery group, but the differences between groups seem to converge as follow-up continues. When aggressive treatment aimed at substantial reduction of IOP from baseline is used, loss of VF can be seen to be minimal in general. Because four to five years of follow-up in a chronic disease is not adequate to draw treatment conclusions, these interim CIGTS outcomes do not support altering current treatment approaches in open-angle glaucoma.
Dr P.R. Lichter, W.K. Kellogg Eye Center, University of Michigan, 1000 Wall Street, Ann Arbor, MI 48105, USA
Classification:
11.1 General management, indication (Part of: 11 Medical treatment)