Abstract
Treatments for open-angle glaucoma aim to prevent vision loss through lowering of intraocular pressure, but to our knowledge no placebo-controlled trials have assessed visual function preservation, and the observation periods of previous (unmasked) trials have typically been at least 5 years. We assessed vision preservation in patients given latanoprost compared with those given placebo. In this randomised, triple-masked, placebo-controlled trial, we enrolled patients with newly diagnosed open-angle glaucoma at ten UK centres (tertiary referral centres, teaching hospitals, and district general hospitals). Eligible patients were randomly allocated (1:1) with a website-generated randomisation schedule, stratified by centre and with a permuted block design, to receive either latanoprost 0·005% (intervention group) or placebo (control group) eye drops. Drops were administered from identical bottles, once a day, to both eyes. The primary outcome was time to visual field deterioration within 24 months. Analyses were done in all individuals with follow-up data. The Data and Safety Monitoring Committee (DSMC) recommended stopping the trial on Jan 6, 2011 (last patient visit July, 2011), after an interim analysis, and suggested a change in primary outcome from the difference in proportions of patients with incident progression between groups to time to visual field deterioration within 24 months. This trial is registered, number ISRCTN96423140. We enrolled 516 individuals between Dec 1, 2006, and March 16, 2010. Baseline mean intraocular pressure was 19·6 mm Hg (SD 4·6) in 258 patients in the latanoprost group and 20·1 mm Hg (4·8) in 258 controls. At 24 months, mean reduction in intraocular pressure was 3·8 mm Hg (4·0) in 231 patients assessed in the latanoprost group and 0·9 mm Hg (3·8) in 230 patients assessed in the placebo group. Visual field preservation was significantly longer in the latanoprost group than in the placebo group: adjusted hazard ratio (HR) 0·44 (95% CI 0·28-0·69; p=0·0003). We noted 18 serious adverse events, none attributable to the study drug. This is the first randomised placebo-controlled trial to show preservation of the visual field with an intraocular-pressure-lowering drug in patients with open-angle glaucoma. The study design enabled significant differences in vision to be assessed in a relatively short observation period. Pfizer, UK National Institute for Health Research Biomedical Research Centre.
Highlights
Open-angle glaucoma is a chronic progressive optic neuropathy that causes a loss of vision, predominantly affecting the mid-peripheral visual field at first and later damaging central vision as the disease progresses; increasingly evidence suggests unrecognised damage to central vision early in the disease course
Drugs to reduce intraocular pressure have been used for decades to slow or halt progressive vision loss in patients with open-angle glaucoma, yet there has been no placebo-controlled trial to assess vision preservation with this treatment
The United Kingdom Glaucoma Treatment Study (UKGTS) is the first placebo-controlled trial to assess the effect of intraocular-lowering treatment on vision preservation
Summary
Open-angle glaucoma is a chronic progressive optic neuropathy that causes a loss of vision, predominantly affecting the mid-peripheral visual field at first and later damaging central vision as the disease progresses; increasingly evidence suggests unrecognised damage to central vision early in the disease course. Glaucomatous vision loss is associated with restricted mobility,[1] falls and motor vehicle accidents,[2] and is the leading cause of irreversible blindness worldwide and the second major cause for blind registration in the UK.[3,4] The prevalence of open-angle glaucoma increases exponentially with age and the level of intraocular pressure.[5] Drugs to reduce intraocular pressure have been used for decades to slow or halt progressive vision loss in patients with open-angle glaucoma, yet there has been no placebo-controlled trial to assess vision preservation with this treatment. The first-choice drug is a prostaglandin analogue,[6] a recent Cochrane review of medical interventions for glaucoma reported no published evidence for a protective effect on vision.[7] The United Kingdom Glaucoma Treatment Study (UKGTS) is the first placebo-controlled trial to assess the effect of intraocular-lowering treatment on vision preservation
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