TY - JOUR
T1 - Effectiveness of early lens extraction for the treatment of primary angle-closure glaucoma (EAGLE)
T2 - a randomised controlled trial
AU - for the EAGLE study group
AU - Azuara-Blanco, Augusto
AU - Burr, Jennifer
AU - Ramsay, Craig
AU - Cooper, David
AU - Foster, Paul J.
AU - Friedman, David S.
AU - Scotland, Graham
AU - Javanbakht, Mehdi
AU - Cochrane, Claire
AU - Norrie, John
N1 - Funding Information:
PJF is supported by salary funding from the National Institute for Health Research (NIHR) through a grant to the Biomedical Research Centre at Moorfields Eye Hospital and UCL Institute of Ophthalmology. This work is supported by the Medical Research Council (MRC G0701604) and funding is managed by the NIHR (NIHR-EME 09-800-26) on behalf of the MRC–NIHR partnership. The views and opinions expressed in this Article are those of the authors and do not necessarily reflect those of the funder of the study. We thank Luke Vale, University of Newcastle, Newcastle, UK, who was the lead health economist involved in the conception, design, funding application, and implementation of the study data collection processes before leaving the study's lead institution. We thank Alison McDonald for supporting trial management and Pauline Garden, and Gladys McPherson for developing and supporting the trial webpage and electronic data transfer, all at the Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK. We also thank the EAGLE participants and recruitment sites.
Publisher Copyright:
© 2016 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY license
PY - 2016/10/1
Y1 - 2016/10/1
N2 - Background Primary angle-closure glaucoma is a leading cause of irreversible blindness worldwide. In early-stage disease, intraocular pressure is raised without visual loss. Because the crystalline lens has a major mechanistic role, lens extraction might be a useful initial treatment. Methods From Jan 8, 2009, to Dec 28, 2011, we enrolled patients from 30 hospital eye services in five countries. Randomisation was done by a web-based application. Patients were assigned to undergo clear-lens extraction or receive standard care with laser peripheral iridotomy and topical medical treatment. Eligible patients were aged 50 years or older, did not have cataracts, and had newly diagnosed primary angle closure with intraocular pressure 30 mm Hg or greater or primary angle-closure glaucoma. The co-primary endpoints were patient-reported health status, intraocular pressure, and incremental cost-effectiveness ratio per quality-adjusted life-year gained 36 months after treatment. Analysis was by intention to treat. This study is registered, number ISRCTN44464607. Findings Of 419 participants enrolled, 155 had primary angle closure and 263 primary angle-closure glaucoma. 208 were assigned to clear-lens extraction and 211 to standard care, of whom 351 (84%) had complete data on health status and 366 (87%) on intraocular pressure. The mean health status score (0·87 [SD 0·12]), assessed with the European Quality of Life-5 Dimensions questionnaire, was 0·052 higher (95% CI 0·015–0·088, p=0·005) and mean intraocular pressure (16·6 [SD 3·5] mm Hg) 1·18 mm Hg lower (95% CI –1·99 to –0·38, p=0·004) after clear-lens extraction than after standard care. The incremental cost-effectiveness ratio was £14 284 for initial lens extraction versus standard care. Irreversible loss of vision occurred in one participant who underwent clear-lens extraction and three who received standard care. No patients had serious adverse events. Interpretation Clear-lens extraction showed greater efficacy and was more cost-effective than laser peripheral iridotomy, and should be considered as an option for first-line treatment. Funding Medical Research Council.
AB - Background Primary angle-closure glaucoma is a leading cause of irreversible blindness worldwide. In early-stage disease, intraocular pressure is raised without visual loss. Because the crystalline lens has a major mechanistic role, lens extraction might be a useful initial treatment. Methods From Jan 8, 2009, to Dec 28, 2011, we enrolled patients from 30 hospital eye services in five countries. Randomisation was done by a web-based application. Patients were assigned to undergo clear-lens extraction or receive standard care with laser peripheral iridotomy and topical medical treatment. Eligible patients were aged 50 years or older, did not have cataracts, and had newly diagnosed primary angle closure with intraocular pressure 30 mm Hg or greater or primary angle-closure glaucoma. The co-primary endpoints were patient-reported health status, intraocular pressure, and incremental cost-effectiveness ratio per quality-adjusted life-year gained 36 months after treatment. Analysis was by intention to treat. This study is registered, number ISRCTN44464607. Findings Of 419 participants enrolled, 155 had primary angle closure and 263 primary angle-closure glaucoma. 208 were assigned to clear-lens extraction and 211 to standard care, of whom 351 (84%) had complete data on health status and 366 (87%) on intraocular pressure. The mean health status score (0·87 [SD 0·12]), assessed with the European Quality of Life-5 Dimensions questionnaire, was 0·052 higher (95% CI 0·015–0·088, p=0·005) and mean intraocular pressure (16·6 [SD 3·5] mm Hg) 1·18 mm Hg lower (95% CI –1·99 to –0·38, p=0·004) after clear-lens extraction than after standard care. The incremental cost-effectiveness ratio was £14 284 for initial lens extraction versus standard care. Irreversible loss of vision occurred in one participant who underwent clear-lens extraction and three who received standard care. No patients had serious adverse events. Interpretation Clear-lens extraction showed greater efficacy and was more cost-effective than laser peripheral iridotomy, and should be considered as an option for first-line treatment. Funding Medical Research Council.
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U2 - 10.1016/S0140-6736(16)30956-4
DO - 10.1016/S0140-6736(16)30956-4
M3 - Article
C2 - 27707497
AN - SCOPUS:84994876765
VL - 388
SP - 1389
EP - 1397
JO - The Lancet
JF - The Lancet
SN - 0140-6736
IS - 10052
ER -