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

TAGS Study Group; Anthony J King; Jemma Hudson; Gordon Fernie; Ashleigh Kernohan; Augusto Azuara-Blanco; Jennifer Burr; Tara Homer; Hosein Shabaninejad; John M Sparrow; David Garway-Heath; Keith Barton; John Norrie; Alison McDonald; Luke Vale; Graeme MacLennan; Obaid Kousha

doi:10.1136/bmj.n1014

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

TAGS Study Group, Anthony J King^*, Jemma Hudson, Gordon Fernie, Ashleigh Kernohan, Augusto Azuara-Blanco, Jennifer Burr, Tara Homer, Hosein Shabaninejad, John M Sparrow, David Garway-Heath, Keith Barton, John Norrie, Alison McDonald, Luke Vale, Graeme MacLennan, Obaid Kousha

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Article number	n1014
Number of pages	11
Journal	BMJ
Volume	373
DOIs	https://doi.org/10.1136/bmj.n1014
Publication status	Published - 12 May 2021

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TAGS Study Group, King, A. J., Hudson, J., Fernie, G., Kernohan, A., Azuara-Blanco, A., Burr, J., Homer, T., Shabaninejad, H., Sparrow, J. M., Garway-Heath, D., Barton, K., Norrie, J., McDonald, A., Vale, L., MacLennan, G., & Kousha, O. (2021). Primary trabeculectomy for advanced glaucoma: pragmatic multicentre randomised controlled trial (TAGS). BMJ, 373, Article n1014. https://doi.org/10.1136/bmj.n1014

@article{9ffa393d9cc64f6980a21e8a134a058a,

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.",

author = "{TAGS Study Group} and 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 Anthony King and Pavi Agrawal and Richard Stead and Broadway, {David C} and Nick Strouthidis and Shenton Chew and Chelvin Sng and Marta Toth and Gus Gazzard and Ahmed Elkarmouty and Eleni Nikita and Giacinto Triolo and Soledad Aguilar-Munoa and Saurabh Goyal and Sheng Lim and Velota Sung and Imran Masood and Nicholas Wride and Amanjeet Sandhu and Elizabeth Hill and John Sparrow and Fiona Grey and Rupert Bourne and Gnanapragasam Nithyanandarajah and Catherine Willshire and Philip Bloom and Faisal Ahmed and Franesca Cordeiro and Laura Crawley and Eduardo Normando and Sally Ameen and Joanna Tryfinopoulou and Alistair Porteous and Gurjeet Jutley and Obaid Kousha",

note = "Funding: The project was funded by the National Institute of Health Research (NIHR) Health Technology Assessment (HTA) Programme (project number 12/35/38). The Health Services Research Unit is funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. ",

year = "2021",

month = may,

day = "12",

doi = "10.1136/bmj.n1014",

language = "English",

volume = "373",

journal = "BMJ",

issn = "0959-8138",

publisher = "BMJ Publishing Group Ltd",

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TAGS Study Group, King, AJ, Hudson, J, Fernie, G, Kernohan, A, Azuara-Blanco, A, Burr, J, Homer, T, Shabaninejad, H, Sparrow, JM, Garway-Heath, D, Barton, K, Norrie, J, McDonald, A, Vale, L, MacLennan, G & Kousha, O 2021, 'Primary trabeculectomy for advanced glaucoma: pragmatic multicentre randomised controlled trial (TAGS)', BMJ, vol. 373, n1014. https://doi.org/10.1136/bmj.n1014

TY - JOUR

T1 - Primary trabeculectomy for advanced glaucoma

T2 - pragmatic multicentre randomised controlled trial (TAGS)

AU - TAGS Study Group

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 - King, Anthony

AU - Agrawal, Pavi

AU - Stead, Richard

AU - Broadway, David C

AU - Strouthidis, Nick

AU - Chew, Shenton

AU - Sng, Chelvin

AU - Toth, Marta

AU - Gazzard, Gus

AU - Elkarmouty, Ahmed

AU - Nikita, Eleni

AU - Triolo, Giacinto

AU - Aguilar-Munoa, Soledad

AU - Goyal, Saurabh

AU - Lim, Sheng

AU - Sung, Velota

AU - Masood, Imran

AU - Wride, Nicholas

AU - Sandhu, Amanjeet

AU - Hill, Elizabeth

AU - Sparrow, John

AU - Grey, Fiona

AU - Bourne, Rupert

AU - Nithyanandarajah, Gnanapragasam

AU - Willshire, Catherine

AU - Bloom, Philip

AU - Ahmed, Faisal

AU - Cordeiro, Franesca

AU - Crawley, Laura

AU - Normando, Eduardo

AU - Ameen, Sally

AU - Tryfinopoulou, Joanna

AU - Porteous, Alistair

AU - Jutley, Gurjeet

AU - Kousha, Obaid

N1 - Funding: The project was funded by the National Institute of Health Research (NIHR) Health Technology Assessment (HTA) Programme (project number 12/35/38). The Health Services Research Unit is funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates.

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.

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.

U2 - 10.1136/bmj.n1014

DO - 10.1136/bmj.n1014

M3 - Article

SN - 0959-8138

VL - 373

JO - BMJ

JF - BMJ

M1 - n1014

ER -

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

Abstract

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