Primary trabeculectomy for advanced glaucoma: pragmatic multicentre randomised controlled trial (TAGS)

TAGS Study Group

doi:10.1136/bmj.n1014

Primary trabeculectomy for advanced glaucoma: pragmatic multicentre randomised controlled trial (TAGS)

TAGS Study Group

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Abstract

OBJECTIVE: To determine whether primary trabeculectomy or primary medical treatment produces better outcomes in term of quality of life, clinical effectiveness, and safety in patients presenting with advanced glaucoma.

DESIGN: Pragmatic multicentre randomised controlled trial.

SETTING: 27 secondary care glaucoma departments in the UK.

PARTICIPANTS: 453 adults presenting with newly diagnosed advanced open angle glaucoma in at least one eye (Hodapp classification) between 3 June 2014 and 31 May 2017.

INTERVENTIONS: Mitomycin C augmented trabeculectomy (n=227) and escalating medical management with intraocular pressure reducing drops (n=226) MAIN OUTCOME MEASURES: Primary outcome: vision specific quality of life measured with Visual Function Questionnaire-25 (VFQ-25) at 24 months.

SECONDARY OUTCOMES: general health status, glaucoma related quality of life, clinical effectiveness (intraocular pressure, visual field, visual acuity), and safety.

RESULTS: At 24 months, the mean VFQ-25 scores in the trabeculectomy and medical arms were 85.4 (SD 13.8) and 84.5 (16.3), respectively (mean difference 1.06, 95% confidence interval -1.32 to 3.43; P=0.38). Mean intraocular pressure was 12.4 (SD 4.7) mm Hg for trabeculectomy and 15.1 (4.8) mm Hg for medical management (mean difference -2.8 (-3.8 to -1.7) mm Hg; P<0.001). Adverse events occurred in 88 (39%) patients in the trabeculectomy arm and 100 (44%) in the medical management arm (relative risk 0.88, 95% confidence interval 0.66 to 1.17; P=0.37). Serious side effects were rare.

CONCLUSION: Primary trabeculectomy had similar quality of life and safety outcomes and achieved a lower intraocular pressure compared with primary medication.

TRIAL REGISTRATION: Health Technology Assessment (NIHR-HTA) Programme (project number: 12/35/38). ISRCTN registry: ISRCTN56878850.

Original language	English
Article number	n1014
Journal	BMJ (Clinical research ed.)
Volume	373
DOIs	https://doi.org/10.1136/bmj.n1014
Publication status	Published - 12 May 2021

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Primary trabeculectomy for advanced glaucoma: pragmatic multicentre randomised controlled trial (TAGS)
Copyright 2021 the authors. This is an open access Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits use, distribution and reproduction for non-commercial purposes, provided the author and source are cited
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title = "Primary trabeculectomy for advanced glaucoma: pragmatic multicentre randomised controlled trial (TAGS)",

abstract = "OBJECTIVE: To determine whether primary trabeculectomy or primary medical treatment produces better outcomes in term of quality of life, clinical effectiveness, and safety in patients presenting with advanced glaucoma.DESIGN: Pragmatic multicentre randomised controlled trial.SETTING: 27 secondary care glaucoma departments in the UK.PARTICIPANTS: 453 adults presenting with newly diagnosed advanced open angle glaucoma in at least one eye (Hodapp classification) between 3 June 2014 and 31 May 2017.INTERVENTIONS: Mitomycin C augmented trabeculectomy (n=227) and escalating medical management with intraocular pressure reducing drops (n=226) MAIN OUTCOME MEASURES: Primary outcome: vision specific quality of life measured with Visual Function Questionnaire-25 (VFQ-25) at 24 months.SECONDARY OUTCOMES: general health status, glaucoma related quality of life, clinical effectiveness (intraocular pressure, visual field, visual acuity), and safety.RESULTS: At 24 months, the mean VFQ-25 scores in the trabeculectomy and medical arms were 85.4 (SD 13.8) and 84.5 (16.3), respectively (mean difference 1.06, 95% confidence interval -1.32 to 3.43; P=0.38). Mean intraocular pressure was 12.4 (SD 4.7) mm Hg for trabeculectomy and 15.1 (4.8) mm Hg for medical management (mean difference -2.8 (-3.8 to -1.7) mm Hg; P<0.001). Adverse events occurred in 88 (39%) patients in the trabeculectomy arm and 100 (44%) in the medical management arm (relative risk 0.88, 95% confidence interval 0.66 to 1.17; P=0.37). Serious side effects were rare.CONCLUSION: Primary trabeculectomy had similar quality of life and safety outcomes and achieved a lower intraocular pressure compared with primary medication.TRIAL REGISTRATION: Health Technology Assessment (NIHR-HTA) Programme (project number: 12/35/38). ISRCTN registry: ISRCTN56878850.",

author = "King, {Anthony J} and Jemma Hudson and Gordon Fernie and Ashleigh Kernohan and Augusto Azuara-Blanco and Jennifer Burr and Tara Homer and Hosein Shabaninejad and Sparrow, {John M} and David Garway-Heath and Keith Barton and John Norrie and Alison McDonald and Luke Vale and Graeme MacLennan and {TAGS Study Group}",

note = "{\textcopyright} Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",

year = "2021",

month = may,

day = "12",

doi = "10.1136/bmj.n1014",

language = "English",

volume = "373",

journal = "BMJ (Clinical research ed.)",

issn = "0959-8138",

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T1 - Primary trabeculectomy for advanced glaucoma: pragmatic multicentre randomised controlled trial (TAGS)

AU - King, Anthony J

AU - Hudson, Jemma

AU - Fernie, Gordon

AU - Kernohan, Ashleigh

AU - Azuara-Blanco, Augusto

AU - Burr, Jennifer

AU - Homer, Tara

AU - Shabaninejad, Hosein

AU - Sparrow, John M

AU - Garway-Heath, David

AU - Barton, Keith

AU - Norrie, John

AU - McDonald, Alison

AU - Vale, Luke

AU - MacLennan, Graeme

AU - TAGS Study Group

PY - 2021/5/12

Y1 - 2021/5/12

N2 - OBJECTIVE: To determine whether primary trabeculectomy or primary medical treatment produces better outcomes in term of quality of life, clinical effectiveness, and safety in patients presenting with advanced glaucoma.DESIGN: Pragmatic multicentre randomised controlled trial.SETTING: 27 secondary care glaucoma departments in the UK.PARTICIPANTS: 453 adults presenting with newly diagnosed advanced open angle glaucoma in at least one eye (Hodapp classification) between 3 June 2014 and 31 May 2017.INTERVENTIONS: Mitomycin C augmented trabeculectomy (n=227) and escalating medical management with intraocular pressure reducing drops (n=226) MAIN OUTCOME MEASURES: Primary outcome: vision specific quality of life measured with Visual Function Questionnaire-25 (VFQ-25) at 24 months.SECONDARY OUTCOMES: general health status, glaucoma related quality of life, clinical effectiveness (intraocular pressure, visual field, visual acuity), and safety.RESULTS: At 24 months, the mean VFQ-25 scores in the trabeculectomy and medical arms were 85.4 (SD 13.8) and 84.5 (16.3), respectively (mean difference 1.06, 95% confidence interval -1.32 to 3.43; P=0.38). Mean intraocular pressure was 12.4 (SD 4.7) mm Hg for trabeculectomy and 15.1 (4.8) mm Hg for medical management (mean difference -2.8 (-3.8 to -1.7) mm Hg; P<0.001). Adverse events occurred in 88 (39%) patients in the trabeculectomy arm and 100 (44%) in the medical management arm (relative risk 0.88, 95% confidence interval 0.66 to 1.17; P=0.37). Serious side effects were rare.CONCLUSION: Primary trabeculectomy had similar quality of life and safety outcomes and achieved a lower intraocular pressure compared with primary medication.TRIAL REGISTRATION: Health Technology Assessment (NIHR-HTA) Programme (project number: 12/35/38). ISRCTN registry: ISRCTN56878850.

AB - OBJECTIVE: To determine whether primary trabeculectomy or primary medical treatment produces better outcomes in term of quality of life, clinical effectiveness, and safety in patients presenting with advanced glaucoma.DESIGN: Pragmatic multicentre randomised controlled trial.SETTING: 27 secondary care glaucoma departments in the UK.PARTICIPANTS: 453 adults presenting with newly diagnosed advanced open angle glaucoma in at least one eye (Hodapp classification) between 3 June 2014 and 31 May 2017.INTERVENTIONS: Mitomycin C augmented trabeculectomy (n=227) and escalating medical management with intraocular pressure reducing drops (n=226) MAIN OUTCOME MEASURES: Primary outcome: vision specific quality of life measured with Visual Function Questionnaire-25 (VFQ-25) at 24 months.SECONDARY OUTCOMES: general health status, glaucoma related quality of life, clinical effectiveness (intraocular pressure, visual field, visual acuity), and safety.RESULTS: At 24 months, the mean VFQ-25 scores in the trabeculectomy and medical arms were 85.4 (SD 13.8) and 84.5 (16.3), respectively (mean difference 1.06, 95% confidence interval -1.32 to 3.43; P=0.38). Mean intraocular pressure was 12.4 (SD 4.7) mm Hg for trabeculectomy and 15.1 (4.8) mm Hg for medical management (mean difference -2.8 (-3.8 to -1.7) mm Hg; P<0.001). Adverse events occurred in 88 (39%) patients in the trabeculectomy arm and 100 (44%) in the medical management arm (relative risk 0.88, 95% confidence interval 0.66 to 1.17; P=0.37). Serious side effects were rare.CONCLUSION: Primary trabeculectomy had similar quality of life and safety outcomes and achieved a lower intraocular pressure compared with primary medication.TRIAL REGISTRATION: Health Technology Assessment (NIHR-HTA) Programme (project number: 12/35/38). ISRCTN registry: ISRCTN56878850.

U2 - 10.1136/bmj.n1014

DO - 10.1136/bmj.n1014

M3 - Article

C2 - 33980505

SN - 0959-8138

VL - 373

JO - BMJ (Clinical research ed.)

JF - BMJ (Clinical research ed.)

M1 - n1014

ER -

Primary trabeculectomy for advanced glaucoma: pragmatic multicentre randomised controlled trial (TAGS)

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