The Glaucoma Intensive Treatment Study (GITS): A Randomized Controlled Trial Comparing Intensive and Standard Treatment on 5 Years Visual Field Development.

ABSTRACT

PURPOSE: To assess the effect of an intensive initial intraocular pressure (IOP)-lowering treatment strategy on the progression of visual field damage. DESIGN: A randomized, controlled, open-label, 2-center clinical trial. METHODS: A total of 242 patients with newly detected early or moderate untreated open-angle glaucoma were enrolled at 2 university hospitals in Sweden. Participants were randomly allocated (11) to either initial treatment with intensive IOP-lowering medications followed by 360° laser trabeculoplasty (LTP), or to traditional mono-therapy, which was increased when deemed necessary. The primary study outcome of interest was the predicted remaining visual field, as measured by the visual field index (VFI) at projected end of life. RESULTS: The median untreated IOP was 24 mm Hg in both treatment groups. During follow-up, median and mode IOP were 17 mm Hg in the mono- and 14 mm Hg in the multi-treatment group. In the mono-treatment group, the median VFI at projected end of life was 79.3% and in the multi-treatment group 87.1% (P = .15). The annual rate of progression of visual field damage was faster in mono-treatment than in multi-treatment participants; median losses per year were 0.65 and 0.25 percentage units, respectively (P = .09). Progression events occurred in 21% of the mono- and in 11% of the multi-treatment participants (P = .03). Adverse events, mostly mild, were reported in 25% of the mono- and in 36% of the multi-treatment participants. Differences in visual field outcomes between treatment groups were more pronounced in participants having higher baseline IOP, defined by median split of untreated IOP values. CONCLUSIONS: In the overall analysis, the visual field outcomes were not overwhelmingly better in the multi-treatment group, but post hoc analysis showed definite benefit in patients with higher untreated IOP. Based on the results of this study, initial intensive treatment may be considered in glaucoma patients with high untreated IOP at diagnosis, although we found no evidence that multi-therapy should be given routinely to all glaucoma patients.