Effectiveness of early lens extraction for the treatment of primary angle-closure glaucoma (EAGLE): a randomised controlled trial

Augusto Azuara-Blanco; Jennifer Burr; Craig Ramsay; David Cooper; Paul J. Foster; David S. Friedman; Graham Scotland; Mehdi Javanbakht; Claire Cochran; John Norrie; Eagle Study Group

doi:10.1016/S0140-6736(16)30956-4

Effectiveness of early lens extraction for the treatment of primary angle-closure glaucoma (EAGLE): a randomised controlled trial

Augusto Azuara-Blanco (Corresponding Author), Jennifer Burr, Craig Ramsay, David Cooper, Paul J. Foster, David S. Friedman, Graham Scotland, Mehdi Javanbakht, Claire Cochran, John Norrie, Eagle Study Group

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Abstract

Background
Primary angle-closure glaucoma (PACG) is a leading cause of irreversible blindness worldwide. In its early stage, primary angle-closure (PAC), there is increased intraocular pressure (IOP) but no visual loss. Because the crystalline lens has a major mechanistic role, lens extraction as initial treatment may be more effective than standard treatment, laser peripheral iridotomy.
Methods
In this randomized controlled trial we compared lens extraction versus laser peripheral iridotomy (1:1). We enrolled 419 participants from 30 hospital eye services in five countries. A web-based randomization application was used. Participants were ≥ 50 years, without cataract, and newly diagnosed with (1) PAC with IOP above 30 mmHg (n=155) or (2) PACG (n=263). The primary outcome was multidimensional measuring, at three years, patient reported health status (EQ-5D), clinical efficacy (IOP) and efficiency (incremental cost effectiveness ratio [ICER] per Quality Adjusted life year [QALY] gained, from a UK health service perspective). IOP measurements were masked. An intent-to-treat analysis was conducted. (ISRCTN 44464607).
Findings
EQ-5D and IOP data at three years were complete in 351 (83.8%) and 366 (87.4%) participants, respectively. After lens extraction (n=208) EQ-5D (0·87, SD 0·12) was 0·052 higher (95% CI 0·015, 0·088, p=0·005) and IOP (16·6 mmHg, SD 3·5) was 1·18 lower (95% CI -1·99, -0·38, p = 0.004) than after laser iridotomy (n=211); ICER £14,284 for initial lens extraction versus standard care (n=285). Irreversible loss of vision was rare and occurred in one participant in the lens extraction and three in the laser iridotomy group. Ethnicity, status of fellow eye, and diagnosis did not influence the results.
Interpretation
Initial treatment with lens extraction for PACG and PAC (with IOP above 30 mmHg) is more effective and cost-effective than laser iridotomy after three years and should be considered as an alternative to current practice.

Original language	English
Pages (from-to)	1389-1397
Number of pages	9
Journal	The Lancet
Volume	388
Issue number	10052
DOIs	https://doi.org/10.1016/S0140-6736(16)30956-4
Publication status	Published - 1 Oct 2016

Bibliographical note

Medical Research Council (ref G0701604) and administered by the NIHR-EME (ref 09-800-26)

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10.1016/S0140-6736(16)30956-4Licence: CC BY

Effectiveness of early lens extraction for the treatment of primary angle-closure glaucoma (EAGLE): a randomised controlled trial
Copyright © The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY license. https://creativecommons.org/licenses/by/4.0/
Final published version, 315 KBLicence: CC BY

Craig Ramsay
- School of Medicine, Medical Sciences & Nutrition, Health Services Research Unit (HSRU) - Director of Health Services Research Unit
- Institute of Applied Health Sciences
Person: Academic
Graham Scotland
- School of Medicine, Medical Sciences & Nutrition, Health Economics Research Unit - Personal Chair
- Institute of Applied Health Sciences
Person: Academic

Cite this

Azuara-Blanco, A., Burr, J., Ramsay, C., Cooper, D., Foster, P. J., Friedman, D. S., Scotland, G., Javanbakht, M., Cochran, C., Norrie, J., & Eagle Study Group (2016). Effectiveness of early lens extraction for the treatment of primary angle-closure glaucoma (EAGLE): a randomised controlled trial. The Lancet, 388(10052), 1389-1397. https://doi.org/10.1016/S0140-6736(16)30956-4

Azuara-Blanco, A, Burr, J, Ramsay, C , Cooper, D, Foster, PJ, Friedman, DS, Scotland, G, Javanbakht, M, Cochran, C, Norrie, J & Eagle Study Group 2016, 'Effectiveness of early lens extraction for the treatment of primary angle-closure glaucoma (EAGLE): a randomised controlled trial', The Lancet, vol. 388, no. 10052, pp. 1389-1397. https://doi.org/10.1016/S0140-6736(16)30956-4

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title = "Effectiveness of early lens extraction for the treatment of primary angle-closure glaucoma (EAGLE): a randomised controlled trial",

abstract = "BackgroundPrimary angle-closure glaucoma (PACG) is a leading cause of irreversible blindness worldwide. In its early stage, primary angle-closure (PAC), there is increased intraocular pressure (IOP) but no visual loss. Because the crystalline lens has a major mechanistic role, lens extraction as initial treatment may be more effective than standard treatment, laser peripheral iridotomy. MethodsIn this randomized controlled trial we compared lens extraction versus laser peripheral iridotomy (1:1). We enrolled 419 participants from 30 hospital eye services in five countries. A web-based randomization application was used. Participants were ≥ 50 years, without cataract, and newly diagnosed with (1) PAC with IOP above 30 mmHg (n=155) or (2) PACG (n=263). The primary outcome was multidimensional measuring, at three years, patient reported health status (EQ-5D), clinical efficacy (IOP) and efficiency (incremental cost effectiveness ratio [ICER] per Quality Adjusted life year [QALY] gained, from a UK health service perspective). IOP measurements were masked. An intent-to-treat analysis was conducted. (ISRCTN 44464607). Findings EQ-5D and IOP data at three years were complete in 351 (83.8%) and 366 (87.4%) participants, respectively. After lens extraction (n=208) EQ-5D (0·87, SD 0·12) was 0·052 higher (95% CI 0·015, 0·088, p=0·005) and IOP (16·6 mmHg, SD 3·5) was 1·18 lower (95% CI -1·99, -0·38, p = 0.004) than after laser iridotomy (n=211); ICER £14,284 for initial lens extraction versus standard care (n=285). Irreversible loss of vision was rare and occurred in one participant in the lens extraction and three in the laser iridotomy group. Ethnicity, status of fellow eye, and diagnosis did not influence the results. InterpretationInitial treatment with lens extraction for PACG and PAC (with IOP above 30 mmHg) is more effective and cost-effective than laser iridotomy after three years and should be considered as an alternative to current practice. ",

author = "Augusto Azuara-Blanco and Jennifer Burr and Craig Ramsay and David Cooper and Foster, {Paul J.} and Friedman, {David S.} and Graham Scotland and Mehdi Javanbakht and Claire Cochran and John Norrie and {Eagle Study Group}",

note = "Medical Research Council (ref G0701604) and administered by the NIHR-EME (ref 09-800-26)",

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doi = "10.1016/S0140-6736(16)30956-4",

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T1 - Effectiveness of early lens extraction for the treatment of primary angle-closure glaucoma (EAGLE)

T2 - a randomised controlled trial

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 - Cochran, Claire

AU - Norrie, John

AU - Eagle Study Group

N1 - Medical Research Council (ref G0701604) and administered by the NIHR-EME (ref 09-800-26)

PY - 2016/10/1

Y1 - 2016/10/1

N2 - BackgroundPrimary angle-closure glaucoma (PACG) is a leading cause of irreversible blindness worldwide. In its early stage, primary angle-closure (PAC), there is increased intraocular pressure (IOP) but no visual loss. Because the crystalline lens has a major mechanistic role, lens extraction as initial treatment may be more effective than standard treatment, laser peripheral iridotomy. MethodsIn this randomized controlled trial we compared lens extraction versus laser peripheral iridotomy (1:1). We enrolled 419 participants from 30 hospital eye services in five countries. A web-based randomization application was used. Participants were ≥ 50 years, without cataract, and newly diagnosed with (1) PAC with IOP above 30 mmHg (n=155) or (2) PACG (n=263). The primary outcome was multidimensional measuring, at three years, patient reported health status (EQ-5D), clinical efficacy (IOP) and efficiency (incremental cost effectiveness ratio [ICER] per Quality Adjusted life year [QALY] gained, from a UK health service perspective). IOP measurements were masked. An intent-to-treat analysis was conducted. (ISRCTN 44464607). Findings EQ-5D and IOP data at three years were complete in 351 (83.8%) and 366 (87.4%) participants, respectively. After lens extraction (n=208) EQ-5D (0·87, SD 0·12) was 0·052 higher (95% CI 0·015, 0·088, p=0·005) and IOP (16·6 mmHg, SD 3·5) was 1·18 lower (95% CI -1·99, -0·38, p = 0.004) than after laser iridotomy (n=211); ICER £14,284 for initial lens extraction versus standard care (n=285). Irreversible loss of vision was rare and occurred in one participant in the lens extraction and three in the laser iridotomy group. Ethnicity, status of fellow eye, and diagnosis did not influence the results. InterpretationInitial treatment with lens extraction for PACG and PAC (with IOP above 30 mmHg) is more effective and cost-effective than laser iridotomy after three years and should be considered as an alternative to current practice.

AB - BackgroundPrimary angle-closure glaucoma (PACG) is a leading cause of irreversible blindness worldwide. In its early stage, primary angle-closure (PAC), there is increased intraocular pressure (IOP) but no visual loss. Because the crystalline lens has a major mechanistic role, lens extraction as initial treatment may be more effective than standard treatment, laser peripheral iridotomy. MethodsIn this randomized controlled trial we compared lens extraction versus laser peripheral iridotomy (1:1). We enrolled 419 participants from 30 hospital eye services in five countries. A web-based randomization application was used. Participants were ≥ 50 years, without cataract, and newly diagnosed with (1) PAC with IOP above 30 mmHg (n=155) or (2) PACG (n=263). The primary outcome was multidimensional measuring, at three years, patient reported health status (EQ-5D), clinical efficacy (IOP) and efficiency (incremental cost effectiveness ratio [ICER] per Quality Adjusted life year [QALY] gained, from a UK health service perspective). IOP measurements were masked. An intent-to-treat analysis was conducted. (ISRCTN 44464607). Findings EQ-5D and IOP data at three years were complete in 351 (83.8%) and 366 (87.4%) participants, respectively. After lens extraction (n=208) EQ-5D (0·87, SD 0·12) was 0·052 higher (95% CI 0·015, 0·088, p=0·005) and IOP (16·6 mmHg, SD 3·5) was 1·18 lower (95% CI -1·99, -0·38, p = 0.004) than after laser iridotomy (n=211); ICER £14,284 for initial lens extraction versus standard care (n=285). Irreversible loss of vision was rare and occurred in one participant in the lens extraction and three in the laser iridotomy group. Ethnicity, status of fellow eye, and diagnosis did not influence the results. InterpretationInitial treatment with lens extraction for PACG and PAC (with IOP above 30 mmHg) is more effective and cost-effective than laser iridotomy after three years and should be considered as an alternative to current practice.

U2 - 10.1016/S0140-6736(16)30956-4

DO - 10.1016/S0140-6736(16)30956-4

M3 - Article

SN - 0140-6736

VL - 388

SP - 1389

EP - 1397

JO - The Lancet

JF - The Lancet

IS - 10052

ER -

Effectiveness of early lens extraction for the treatment of primary angle-closure glaucoma (EAGLE): a randomised controlled trial

Abstract

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Craig Ramsay

Graham Scotland

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