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

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Author(s)

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

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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.
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Details

Original languageEnglish
Article numbern1014
Number of pages11
JournalBMJ
Volume373
DOIs
Publication statusPublished - 12 May 2021

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