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David Garway-Heath, Gerassimos Lascaratos, Catey Bunce, David Crabb, Richard Russell, Ameet Shah, Katsuyoshi Suzuki, Edward White, Francesca Amalfitano, UKGTS Investigators; The United Kingdom Glaucoma Treatment Study (UKGTS): baseline characteristics and main outcomes. Invest. Ophthalmol. Vis. Sci. 2013;54(15):2619.
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Medical IOP reduction is the standard initial treatment for open angle glaucoma (OAG), yet no randomized placebo-controlled study of medical IOP reduction has been undertaken previously.
The United Kingdom Glaucoma Treatment Study (UKGTS) is the first randomized, double-masked, placebo-controlled, multi-centre medical treatment trial for OAG. 516 newly-diagnosed (previously untreated) patients with OAG were prospectively recruited at 10 UK centres between 2007 and 2010.The observation period was 2 years, with subjects monitored by visual field (VF) testing, quantitative imaging, optic disc photography and tonometry at 11 visits. Eligible patients were assigned by concealed telephone allocation to treatment with latanoprost 0.005% or placebo. The primary outcome measure was time to VF deterioration within 24 months, based on Humphrey VF Analyzer GPA criteria.
Mean (±SD) subject age was 66(±11) years and 52.9% were male. The baseline mean IOP (±SD) was 18.9±4mmHg in the better mean deviation (MD) eyes (median [IQR] MD -1.27dB [-2.37, -0.19]) and 19.9±4.6mmHg in the worse MD eyes (median [IQR] MD -3.30dB [-5.60, -1.98]). Survival analysis showed a significant difference in the time from baseline to confirmed VF progression between the two treatment groups (p=0.0012) (Fig.1). The adjusted hazard ratio by site was 0.498 (95% CI 0.332, 0.747). The median (IQR) MD slope for all eyes with reliable VFs on at least 5 visits was 0.17 (-0.34 to 0.51) dB/year and -0.05 (-0.70 to 0.49) dB/year for the latanoprost and placebo groups, respectively (p=0.0003). The mean IOP reduction from the pre-allocation visit to the first visit post-treatment allocation was greater in the latanoprost group (4.5mmHg) as compared to the placebo (0.6mmHg). 127 patients who did not reach an endpoint failed to complete 2 years’ follow-up 24.6%).
The UKGTS is the first randomized, placebo-controlled trial to show the efficacy of medical treatment in reducing VF deterioration in OAG. The observation period was short (2 years) compared to most trials; the analysis of deterioration velocity and inclusion of quantitative imaging has the potential to reduce the number of patients and/or duration required for subsequent clinical trials and will be modelled in subsequent analyses.
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