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Multicenter Study
. 2021 May 12:373:n1014.
doi: 10.1136/bmj.n1014.

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

Anthony J King  1 , Jemma Hudson  2 , Gordon Fernie  3 , Ashleigh Kernohan  4 , Augusto Azuara-Blanco  5 , Jennifer Burr  6 , Tara Homer  4 , Hosein Shabaninejad  4 , John M Sparrow  7 , David Garway-Heath  8 , Keith Barton  8 , John Norrie  9 , Alison McDonald  3 , Luke Vale  4 , Graeme MacLennan  3 ; TAGS Study Group
Collaborators, Affiliations
Multicenter Study

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

Anthony J King et al. BMJ. .

Erratum in

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.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/coi_disclosure.pdf and declare: support from the NIHR-HTA programme for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years, no other relationships or activities that could appear to have influenced the submitted work.

Figures

Fig 1
Fig 1
Trial consort diagram
Fig 2
Fig 2
Mean National Eye Institute Visual Function Questionnaire (25 items) (VFQ-25), EuroQol Group’s 5 dimension 5-level health status questionnaire (EQ-5D-5L), Health Utility Index-mark 3 (HUI-3), and Glaucoma Utility Index (GUI) scores. For VFQ-25, range of values is from 0 for lowest visual quality of life to 100 for highest visual quality of life. For EQ-5D and HUI-3, score of 0 is state equivalent to death and 1 is full health. For GUI, 0 is worst state in terms of effects of glaucoma and side effects of treatments and 1 is best possible state
Fig 3
Fig 3
Mean (95% CI) intraocular pressure (IOP) for index eye by group over time
See this image and copyright information in PMC

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