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Title: The effectiveness of early lens extraction with intraocular lens implantation for the treatment of primary angle-closure glaucoma (EAGLE) : study protocol for a randomized controlled trial
Authors: Azuara-Blanco, Augusto
Burr, Jennifer M.
Cochran, Claire
Ramsay, Craig
Vale, Luke
Foster, Paul
Friedman, David
Quayyum, Zahidul
Lai, Jimmy
Nolan, Winnie
Aung, Tin
Chew, Paul
McPherson, Gladys
McDonald, Alison
Norrie, John
Effectiveness in Angle-closure Glaucoma of Lens Extraction (EAGLE) Study Group
Keywords: Visual function questionnaire
Cataract-surgery
Clinical-trial
Progression
Blindness
cost
Phacoemulsification
RE Ophthalmology
Issue Date: 23-May-2011
Citation: Azuara-Blanco , A , Burr , J M , Cochran , C , Ramsay , C , Vale , L , Foster , P , Friedman , D , Quayyum , Z , Lai , J , Nolan , W , Aung , T , Chew , P , McPherson , G , McDonald , A , Norrie , J & Effectiveness in Angle-closure Glaucoma of Lens Extraction (EAGLE) Study Group 2011 , ' The effectiveness of early lens extraction with intraocular lens implantation for the treatment of primary angle-closure glaucoma (EAGLE) : study protocol for a randomized controlled trial ' Trials , vol 12 , 133 .
Abstract: Background: Glaucoma is the leading cause of irreversible blindness. Although primary open-angle glaucoma is more common, primary angle-closure glaucoma (PACG) is more likely to result in irreversible blindness. By 2020, 5.3 million people worldwide will be blind because of PACG. The current standard care for PACG is a stepped approach of a combination of laser iridotomy surgery (to open the drainage angle) and medical treatment (to reduce intraocular pressure). If these treatments fail, glaucoma surgery (eg, trabeculectomy) is indicated. It has been proposed that, because the lens of the eye plays a major role in the mechanisms leading to PACG, early clear lens extraction will improve glaucoma control by opening the drainage angle. This procedure might reduce the need for drugs and glaucoma surgery, maintain good visual acuity, and improve quality of life compared with standard care. EAGLE aims to evaluate whether early lens extraction improves patient-reported, clinical outcomes, and cost-effectiveness, compared with standard care. Methods/Design: EAGLE is a multicentre pragmatic randomized trial. All people presenting to the recruitment centres in the UK and east Asia with newly diagnosed PACG and who are at least 50 years old are eligible. The primary outcomes are EQ-5D, intraocular pressure, and incremental cost per quality adjusted life year (QALY) gained. Other outcomes are: vision and glaucoma-specific patient-reported outcomes, visual acuity, visual field, angle closure, number of medications, additional surgery (e. g., trabeculectomy), costs to the health services and patients, and adverse events. A single main analysis will be done at the end of the trial, after three years of follow-up. The analysis will be based on all participants as randomized (intention to treat). 400 participants (200 in each group) will be recruited, to have 90% power at 5% significance level to detect a difference in EQ-5D score between the two groups of 0.05, and a mean difference in intraocular pressure of 1.75 mm Hg. The study will have 80% power to detect a difference of 15% in the glaucoma surgery rate. Trial Registration: ISRCTN44464607.
Version: Publisher PDF
Status: Peer reviewed
URI: http://hdl.handle.net/10023/2399
DOI: http://dx.doi.org/10.1186/1745-6215-12-133
ISSN: 1745-6215
Type: Journal article
Rights: © 2011 Azuara-Blanco et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Appears in Collections:University of St Andrews Research
Medicine Research



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