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Article: 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

TitleThe 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
Issue Date2011
PublisherBioMed Central Ltd. The Journal's web site is located at http://www.trialsjournal.com/
Citation
Trials, 2011, v. 12 How to Cite?
AbstractBackground: 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. © 2011 Azuara-Blanco et al; licensee BioMed Central Ltd.
Persistent Identifierhttp://hdl.handle.net/10722/147042
ISSN
2015 Impact Factor: 1.859
2015 SCImago Journal Rankings: 1.077
PubMed Central ID
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorAzuaraBlanco, Aen_HK
dc.contributor.authorBurr, JMen_HK
dc.contributor.authorCochran, Cen_HK
dc.contributor.authorRamsay, Cen_HK
dc.contributor.authorVale, Len_HK
dc.contributor.authorFoster, Pen_HK
dc.contributor.authorFriedman, Den_HK
dc.contributor.authorQuayyum, Zen_HK
dc.contributor.authorLai, Jen_HK
dc.contributor.authorNolan, Wen_HK
dc.contributor.authorAung, Ten_HK
dc.contributor.authorChew, Pen_HK
dc.contributor.authorMcPherson, Gen_HK
dc.contributor.authorMcDonald, Aen_HK
dc.contributor.authorNorrie, Jen_HK
dc.date.accessioned2012-05-23T05:54:39Z-
dc.date.available2012-05-23T05:54:39Z-
dc.date.issued2011en_HK
dc.identifier.citationTrials, 2011, v. 12en_HK
dc.identifier.issn1745-6215en_HK
dc.identifier.urihttp://hdl.handle.net/10722/147042-
dc.description.abstractBackground: 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. © 2011 Azuara-Blanco et al; licensee BioMed Central Ltd.en_HK
dc.languageengen_US
dc.publisherBioMed Central Ltd. The Journal's web site is located at http://www.trialsjournal.com/en_HK
dc.relation.ispartofTrialsen_HK
dc.rightsTrials. Copyright © BioMed Central Ltd.-
dc.rightsThis work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.-
dc.subject.meshGlaucoma, Angle-Closure - diagnosis - economics - physiopathology - surgery-
dc.subject.meshLens Implantation, Intraocular - adverse effects - economics - instrumentation-
dc.subject.meshLens, Crystalline - physiopathology - surgery-
dc.subject.meshPhacoemulsification - adverse effects - economics-
dc.subject.meshResearch Design-
dc.titleThe effectiveness of early lens extraction with intraocular lens implantation for the treatment of primary angle-closure glaucoma (EAGLE): Study protocol for a randomized controlled trialen_HK
dc.typeArticleen_HK
dc.identifier.emailLai, J: laism@hku.hken_HK
dc.identifier.authorityLai, J=rp00295en_HK
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1186/1745-6215-12-133en_HK
dc.identifier.pmid21605352-
dc.identifier.pmcidPMC3121608-
dc.identifier.scopuseid_2-s2.0-79956223077en_HK
dc.identifier.hkuros199517en_US
dc.identifier.hkuros196270-
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-79956223077&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume12en_HK
dc.identifier.isiWOS:000291998100001-
dc.publisher.placeUnited Kingdomen_HK
dc.identifier.scopusauthoridAzuaraBlanco, A=7006394568en_HK
dc.identifier.scopusauthoridBurr, JM=8439989300en_HK
dc.identifier.scopusauthoridCochran, C=40261164700en_HK
dc.identifier.scopusauthoridRamsay, C=7005242161en_HK
dc.identifier.scopusauthoridVale, L=7005915657en_HK
dc.identifier.scopusauthoridFoster, P=7201517537en_HK
dc.identifier.scopusauthoridFriedman, D=7402079597en_HK
dc.identifier.scopusauthoridQuayyum, Z=26644997300en_HK
dc.identifier.scopusauthoridLai, J=7401939748en_HK
dc.identifier.scopusauthoridNolan, W=7006143354en_HK
dc.identifier.scopusauthoridAung, T=26643141900en_HK
dc.identifier.scopusauthoridChew, P=7103396906en_HK
dc.identifier.scopusauthoridMcPherson, G=12760628000en_HK
dc.identifier.scopusauthoridMcDonald, A=14009802400en_HK
dc.identifier.scopusauthoridNorrie, J=7003447956en_HK
dc.identifier.citeulike9378874-

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