Interim clinical outcomes in the Collaborative Initial XXXX Treatment Study comparing initial treatment randomized to medications or surgery.

@entity1 @entity227 @entity1538 @entity231 @entity726 @entity102 @entity1487
PURPOSE: To report interim outcome data, using all available follow-up through 5 years after treatment initiation, in the Collaborative Initial @entity726 Treatment Study (CIGTS). DESIGN: Randomized clinical trial. @entity1 : Six hundred seven newly diagnosed @entity726 @entity1 . METHODS: In a randomized clinical trial, 607 @entity1 with newly diagnosed @entity1538 were initially treated with either medication or trabeculectomy (with or without @entity1487 ). After treatment onset and early follow-up, @entity1 were evaluated clinically at 6-month intervals. In addition, quality of life telephone interviews were conducted at similar frequency to the clinical visits. @entity1 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. @entity227 ( @entity227 ) scores were analyzed by time-specific comparisons and by repeated measures models. MAIN OUTCOME MEASURES: @entity227 loss was the primary outcome variable in CIGTS. Secondary outcomes of visual acuity (VA), IOP, and @entity231 were also studied. RESULTS: On the basis of completed follow-up through 4 years and partially completed through 5 years, @entity227 loss did not differ significantly by initial treatment. Over the entire period of follow-up, surgical @entity1 had a greater risk of substantial VA loss compared with medical @entity1 . However, by 4 years after treatment, the average VA in the two groups was about equal. Over the course of follow-up, IOP in the medicine group has averaged 17 to 18 mmHg, whereas that in the surgery group averaged 14 to 15 mmHg. The rate of @entity231 requiring removal was greater in the surgically treated group. CONCLUSIONS: Both initial medical or initial surgical therapy result in about the same @entity227 outcome after up to 5 years of follow-up. VA loss was greater in the surgery group, but the differences between groups seem to be converging as follow-up continues. When aggressive treatment aimed at substantial reduction in IOP from baseline is used, loss of @entity227 can be seen to be minimal in general. Because 4 to 5 years of follow-up in a @entity102 is not adequate to draw treatment conclusions, these interim CIGTS outcomes do not support altering current treatment approaches to @entity1538 .
