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.
Objectives To report on the causes of blindness certifications in England and Wales in working age adults (16–64 years) in 2009–2010; and to compare these with figures from 1999 to 2000. Design Analysis of the national database of blindness certificates of vision impairment (CVIs) received by the Certifications Office. Setting and participants Working age (16–64 years) population of England and Wales. Main outcome measures Number and cause of blindness certifications. Results The Certifications Office received 1756 CVIs for blindness from persons aged between 16 and 64 inclusive between 1 April 2009 and 31 March 2010. The main causes of blindness certifications were hereditary retinal disorders (354 certifications comprising 20.2% of the total), diabetic retinopathy/maculopathy (253 persons, 14.4%) and optic atrophy (248 persons, 14.1%). Together, these three leading causes accounted for almost 50% of all blindness certifications. Between 1 April 1999 and 31 March 2000, the leading causes of blindness certification were diabetic retinopathy/maculopathy (17.7%), hereditary retinal disorders (15.8%) and optic atrophy (10.1%). Conclusions For the first time in at least five decades, diabetic retinopathy/maculopathy is no longer the leading cause of certifiable blindness among working age adults in England and Wales, having been overtaken by inherited retinal disorders. This change may be related to factors including the introduction of nationwide diabetic retinopathy screening programmes in England and Wales and improved glycaemic control. Inherited retinal disease, now representing the commonest cause of certification in the working age population, has clinical and research implications, including with respect to the provision of care/resources in the NHS and the allocation of research funding.
Primary open angle glaucoma and ocular hypertension are habitually treated with eye drops that lower intraocular pressure. Selective laser trabeculoplasty is a safe alternative but is rarely used as first-line treatment. We compared the two. In this observer-masked, randomised controlled trial treatment-naive patients with open angle glaucoma or ocular hypertension and no ocular comorbidities were recruited between 2012 and 2014 at six UK hospitals. They were randomly allocated (web-based randomisation) to initial selective laser trabeculoplasty or to eye drops. An objective target intraocular pressure was set according to glaucoma severity. The primary outcome was health-related quality of life (HRQoL) at 3 years (assessed by EQ-5D). Secondary outcomes were cost and cost-effectiveness, disease-specific HRQoL, clinical effectiveness, and safety. Analysis was by intention to treat. This study is registered at controlled-trials.com (ISRCTN32038223). Of 718 patients enrolled, 356 were randomised to the selective laser trabeculoplasty and 362 to the eye drops group. 652 (91%) returned the primary outcome questionnaire at 36 months. Average EQ-5D score was 0·89 (SD 0·18) in the selective laser trabeculoplasty group versus 0·90 (SD 0·16) in the eye drops group, with no significant difference (difference 0·01, 95% CI -0·01 to 0·03; p=0·23). At 36 months, 74·2% (95% CI 69·3-78·6) of patients in the selective laser trabeculoplasty group required no drops to maintain intraocular pressure at target. Eyes of patients in the selective laser trabeculoplasty group were within target intracoluar pressure at more visits (93·0%) than in the eye drops group (91·3%), with glaucoma surgery to lower intraocular pressure required in none versus 11 patients. Over 36 months, from an ophthalmology cost perspective, there was a 97% probability of selective laser trabeculoplasty as first treatment being more cost-effective than eye drops first at a willingness to pay of £20 000 per quality-adjusted life-year gained. Selective laser trabeculoplasty should be offered as a first-line treatment for open angle glaucoma and ocular hypertension, supporting a change in clinical practice. National Institute for Health Research, Health and Technology Assessment Programme.
ObjectiveTo report the 2-year outcomes of the BOLT study, a prospective randomized controlled trial evaluating intravitreous bevacizumab and modified Early Treatment Diabetic Retinopathy Study (ETDRS) macular laser therapy (MLT) in patients with persistent clinically significant macular edema (CSME).MethodsIn a 2-year, single-center, randomized controlled trial, 80 patients with center-involving CSME and visual acuity of 20/40 to 20/320 were randomized to receive either bevacizumab or MLT.Main Outcome MeasuresPrimary outcome: difference in ETDRS best-corrected visual acuity (BCVA) between arms. Secondary outcomes: mean change in BCVA, proportion gaining at least 15 and at least 10 ETDRS letters, losing fewer than 15 and at least 30 letters, change in central macular thickness, ETDRS retinopathy severity, and safety outcomes.ResultsAt 2 years, mean (SD) ETDRS BCVA was 64.4 (13.3) (ETDRS equivalent Snellen fraction: 20/50) in the bevacizumab arm and 54.8 (12.6) (20/80) in the MLT arm (P = .005). The bevacizumab arm gained a median of 9 ETDRS letters vs 2.5 letters for MLT (P = .005), with a mean gain of 8.6 letters for bevacizumab vs a mean loss of 0.5 letters for MLT. Forty-nine percent of patients gained 10 or more letters (P = .001) and 32% gained at least 15 letters (P = .004) for bevacizumab vs 7% and 4% for MLT. Percentage who lost fewer than 15 letters in the MLT arm was 86% vs 100% for bevacizumab (P = .03). Mean reduction in central macular thickness was 146 μm in the bevacizumab arm vs 118 μm in the MLT arm. The median number of treatments over 24 months was 13 for bevacizumab and 4 for MLT.ConclusionsThis study provides evidence supporting longer-term use of intravitreous bevacizumab for persistent center-involving CSME.Application to Clinical PracticeImprovements in BCVA and central macular thickness seen with bevacizumab at 1 year were maintained over the second year with a mean of 4 injections.Trial Registrationeudract.ema.europa.eu Identifier: 2007-000847-89