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

Augusto Azuara-Blanco, Jennifer M Burr, Claire Cochran, Craig Ramsay, Luke Vale, Paul Foster, David Friedman, Zahidul Quayyum, Jimmy Lai, Winnie Nolan, Tin Aung, Paul Chew, Gladys McPherson, Alison McDonald, John David Taylor Norrie, Effectiveness in Angle-closure Glaucoma of Lens Extraction (EAGLE) Study Group

Research output: Contribution to journalArticle

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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.
Original languageEnglish
Pages (from-to)133
JournalTrials
Volume12
DOIs
Publication statusPublished - 23 May 2011

Fingerprint

Angle Closure Glaucoma
Intraocular Lens Implantation
Glaucoma
Lenses
Randomized Controlled Trials
Intraocular Pressure
Trabeculectomy
Blindness
Visual Acuity
Drainage
Therapeutics
Pragmatic Clinical Trials
Costs and Cost Analysis
Crystalline Lens
Far East
Quality-Adjusted Life Years
Laser Therapy
Visual Fields
Health Services
Cost-Benefit Analysis

Keywords

  • Asia
  • Cost-Benefit Analysis
  • Glaucoma, Angle-Closure
  • Great Britain
  • Health Care Costs
  • Humans
  • Intraocular Pressure
  • Lens Implantation, Intraocular
  • Lens, Crystalline
  • Lenses, Intraocular
  • Middle Aged
  • Ophthalmic Solutions
  • Phacoemulsification
  • Quality of Life
  • Questionnaires
  • Recovery of Function
  • Research Design
  • Time Factors
  • Trabeculectomy
  • Treatment Outcome
  • Vision, Ocular
  • Visual Acuity
  • Visual Fields

Cite this

Azuara-Blanco, A., Burr, J. M., Cochran, C., Ramsay, C., Vale, L., Foster, P., ... 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, 12, 133. https://doi.org/10.1186/1745-6215-12-133

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. / 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 David Taylor; Effectiveness in Angle-closure Glaucoma of Lens Extraction (EAGLE) Study Group.

In: Trials, Vol. 12, 23.05.2011, p. 133.

Research output: Contribution to journalArticle

Azuara-Blanco, A, Burr, JM, 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, JDT & 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, pp. 133. https://doi.org/10.1186/1745-6215-12-133
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 David Taylor ; Effectiveness in Angle-closure Glaucoma of Lens Extraction (EAGLE) Study Group. / 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. In: Trials. 2011 ; Vol. 12. pp. 133.
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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.",
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TY - JOUR

T1 - The effectiveness of early lens extraction with intraocular lens implantation for the treatment of primary angle-closure glaucoma (EAGLE)

T2 - study protocol for a randomized controlled trial

AU - Azuara-Blanco, Augusto

AU - Burr, Jennifer M

AU - Cochran, Claire

AU - Ramsay, Craig

AU - Vale, Luke

AU - Foster, Paul

AU - Friedman, David

AU - Quayyum, Zahidul

AU - Lai, Jimmy

AU - Nolan, Winnie

AU - Aung, Tin

AU - Chew, Paul

AU - McPherson, Gladys

AU - McDonald, Alison

AU - Norrie, John David Taylor

AU - Effectiveness in Angle-closure Glaucoma of Lens Extraction (EAGLE) Study Group

PY - 2011/5/23

Y1 - 2011/5/23

N2 - 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.

AB - 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.

KW - Asia

KW - Cost-Benefit Analysis

KW - Glaucoma, Angle-Closure

KW - Great Britain

KW - Health Care Costs

KW - Humans

KW - Intraocular Pressure

KW - Lens Implantation, Intraocular

KW - Lens, Crystalline

KW - Lenses, Intraocular

KW - Middle Aged

KW - Ophthalmic Solutions

KW - Phacoemulsification

KW - Quality of Life

KW - Questionnaires

KW - Recovery of Function

KW - Research Design

KW - Time Factors

KW - Trabeculectomy

KW - Treatment Outcome

KW - Vision, Ocular

KW - Visual Acuity

KW - Visual Fields

U2 - 10.1186/1745-6215-12-133

DO - 10.1186/1745-6215-12-133

M3 - Article

VL - 12

SP - 133

JO - Trials

JF - Trials

SN - 1745-6215

ER -