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

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Results

Between 3 June 2014 and 31 May 2017, 453 participants from 27 hospitals were allocated to either trabeculectomy (n=227) or medical management (n=226) (fig 1). In the trabeculectomy arm, 201/227 (89%) participants received trabeculectomy on their index eye. For the remaining 26 participants, four had surgery in their non-index eye, 16 declined surgery, two died before surgery, and four had yet to receive surgery. All participants in the medical management group received their allocated treatment, and 39/226 (17%) went on to receive trabeculectomy within two years.

Fig 1

Trial consort diagram

For those recruited to the study, the mean age of participants was 67.6 (SD 12.3) years and 303/453 (67%) participants were male. For those who were eligible but declined to participate in the trial (n=276), the mean age was slightly higher at 69.6 (12.8) years (P=0.04) and 165 (60%) were male (P=0.17). The study arms were balanced at baseline (table 1). The mean VFQ-25 scores were 87.1 (SD 13.6) and 87.1 (13.4) in the trabeculectomy and medical management arms, respectively. Forty four participants in each arm had advanced glaucoma in both eyes.

Table 1

Baseline characteristics. Values are numbers (percentages) unless stated otherwise

At 24 months, the mean VFQ-25 scores were 85.4 (13.8) and 84.5 (16.3) in the trabeculectomy and medical management arms, respectively. The mean difference was 1.06 (95% confidence interval −1.32 to 3.43; P=0.38) (table 2). The per protocol and complier average causal effect estimates for VFQ-25 were similar. We also found no evidence of any differences between the pre-specified subgroups (supplementary figure A) or for EQ-5D-5L, HUI-3, and GUI at 24 months (table 2; fig 2).

Table 2

Primary and secondary outcomes. Values are mean (SD) unless stated otherwise

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

The mean intraocular pressure at 24 months was 12.4 (SD 4.7) mm Hg for the trabeculectomy arm and 15.1 (4.8) mm Hg for the medical management arm (mean difference −2.75 (95% confidence interval −3.84 to −1.66) mm Hg; P<0.001) (table 2; fig 3). The logMAR visual acuity was higher (worse) in the trabeculectomy arm (mean difference 0.07, 0.02 to 0.11; P=0.006) (table 2). We found no evidence of a difference in visual field mean deviation at 24 months (mean difference 0.18 (−0.58 to 0.94) dB; P=0.65) or other secondary outcomes (table 2).

Fig 3

Mean (95% CI) intraocular pressure (IOP) for index eye by group over time

In total, 88/227 (39%) participants in the trabeculectomy arm and 100/226 (44%) in the medical management arm had a safety event during the 24 month follow-up (relative risk 0.88, 95% confidence interval 0.66 to 1.17; P=0.37) (table 3). Twelve (5%) of 227 participants in the trabeculectomy arm and 8/226 (4%) in the medical management arm had a serious adverse event (relative risk 1.50, 0.62 to 3.66; P=0.38). Eighty four (38%) of 222 participants in the trabeculectomy arm and 93/221 (42%) in the medical management arm had an adverse event (relative risk 0.90, 0.67 to 1.21; P=0.48). Nine deaths occurred, all unrelated to the trial. Two participants developed endophthalmitis, one in each arm of the study, and three lost more than 10 letters of logMAR visual acuity, all in the trabeculectomy group, two owing to progressive glaucoma and one owing to central serous retinopathy.

Table 3

Safety events (index eye where ocular). Values are numbers (percentages)

The need for additional interventions was greater in the trabeculectomy arm. All glaucoma surgery related serious adverse events (flat anterior chamber, ocular perforation during anaesthesia, diplopia, and bleb related endophthalmitis) needed further surgical intervention. Of the adverse events reported, 27 patients needed a further intervention to manage them, 24 in the trabeculectomy arm and three in the medical management arm. At 24 months, fewer participants were receiving topical drugs (53/211; 25%) in the trabeculectomy arm than in the medical management arm (163/208; 78%) (supplementary table C).

Acknowledgments

Sponsor representative: Pauline Hyman-Taylor (from February 2019), Natalie McGregor (March 2015 to February 2019), Audrey Athlan (from July 2014 to March 2015), Joanne Thornhill (from 2013 to July 2014). Patient and public involvement representative: Rick Walsh, Russel Young. CHaRT Trial Office: Mark Forrest (from 2015), Gladys McPherson (until 2015). CHaRT Trial Office data coordinator: Pauline Garden. Health economists: Eoin Maloney (until 2015), Mehdi Javanbakht (until June 2019).

All participants in the trial, staff, and members of the TAGS Investigator Group responsible for recruitment in the clinical centres were as follows: Princess Alexandra Eye Pavilion, Edinburgh, NHS Lothian: Margaret McDonald, Margaret Frost, Angela James, June McGhie, Doreen Stewart, Laura Hughes; University Hospital, Coventry, University Hospitals Coventry and Warwickshire NHS Trust: Jeanette Allison, Margaret Dixon, Marie McCauley, Linzi Randle, Nigel Edwards, Kamaljeet Heer, Amritpal Chaggar, Vishal Thakrar, Suzanna Randen; St Thomas’ Hospital, Guy’s and St Thomas’s NHS Foundation Trust: Stephanie Jones, Alba De Antonio, Andrew Ho, Elizabeth Galvis, Eme Chan, Jennifer Lee, Andrew Amon, Isabelle Chow; Hinchingbrooke Hospital, North West Anglia NHS Foundation Trust: Paula Turnbull, Jane Kean, Aarti Bahirat, Ivailo Zhekov, Chelsea Turnbull, Debra Jones, Aaron Woods, Linda Molloy; Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust: Mini David, Nicola Moss, Tomaz Jazwiecki, Maureen McMahon, Kim Green, Fawne Gibb, Lisa Haines, Rashedul Hoque, Jacqueline Denham, Madhu Mamman; Harrogate and District NHS Foundation Trust: Gillian Ranson, Debbie Wiggins, Caroline Clarke; The Royal Derby Hospital, Derby Hospitals NHS Foundation Trust: Sue Melbourne, Charlotte Downes, Ryan Humphries, Gill Widdowson, Lynsey Havill, John Sharp, Abbie Singleton, Tracy Brear, Howard Fairey, Aariana Sohal, Dorothy Gibson, Mona Mohamed; Royal Victoria Hospital, Belfast Health and Social Care Trust: Rebecca Denham, Louise Scullion, Georgina Sterrett, Deirdre Burns, Lesley Doyle, Graham Young, Paul Wright, Vittorio Silvestri, Nuala Jane Lavery, Jonathan Keenan, Katie Graham; Norwich and Norfolk University Hospital NHS Foundation Trust: Heidi Cate, Sally Edmunds, Corinne Haynes, Karen Le Grys, Naomi Waller, Patricia Young; Manchester University, NHS Foundation Trust: Ian Venables; Kate Barugh, Monika Cien, Raisa Platt, Katie McGuiness, Stephanie Clarke, Daniel Todd, Patrick Gunn, Rosalind Creer, Leanne Richards, Catherine Park, Fatima Ahmed, Thomas Hamper, Deepali Bindal, Harriet Ndu-Melekwe, Martyn Russell, Tanya Karaconji, Brett Drury, Divya Permol; Bristol Eye Hospital, University Hospitals Bristol NHS Foundation Trust: Beth Thorne, Emma Lamb, Ifan Jones, Jack Beange, Eleanor Hiscott, Jess Toole, Leila Cox, Julie Cloake, Clemence Rouquette, Gemma Bizley, Fran Paget, Carrie White, Gemma Brimson, Danielle Lee, Helen Talbot, Claire Buckland, Inderjit Chatha, Katherine Smith, Ketan Kapoor, Sebastian Howard; Sunderland Eye infirmary, City Hospitals Sunderland NHS Foundation Trust: Steve Dodds, Lauren Bell, Wenwei Woo, Jaswant Sandhu, Santy Nocon, Amanjeet Sandhu, Oliver Baylis, Ibrahim Masri, Karim El-Assal, Gemma Sloanes, Elizabeth Hill, David Lunt, Michelle Young, Shweta Singh, Sinead Connolly; Gloucestershire Eye Unit, Cheltenham General Hospital, Gloucestershire Hospitals NHS Foundation Trust: Adrian Blazey, Anthony Burke, Frances Reilly; Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust: Helen Pokora, Maria Edwards, Martin Rhodes, Tom Evans, Jonathan Drury, Emily Henry; Nottingham University Hospitals NHS Trust: Patrick Cox, Lauren Tarr, Rebecca Nicol, Jade Higman, Zoe Bull, Laura Anderson, Renee Cammack, Jessica Kearsley, Athanasia Koumoukeli, Olivia Hay, Salina Saddiqui, Angela Skinner, Imran Jawaid, Alan Kastner, Amie Manjang, Francesco Stringa, Kostas Giannouladis; Queen Margaret Hospital, Dunfermline, NHS Fife: Karen Gray, Paul Allcoat, Julie Aitken, Ruth Robertson, Julie Donaldson, Shiela Hanlon; Warrington and Halton Hospitals NHS Foundation Trust: Mark Halliwell, Lynne Connell, Kerry Bunworth; Maidstone Hospital, Maidstone and Tunbridge Wells NHS Trust: Ruby Einosas, Susan Lord, Laura Reid, Stephanie Tidey, Audrey Perkins, Narkirst Bahra, Lynne Holmes, Sue Crockford, Karen O’Brien, Sara Harrison; Gartnavel General Hospital, NHS Greater Glasgow and Clyde: Aileen Campbell, Vicky Paterson, Geraldine Campbell, Fiona Mcintosh; Moorfields Eye Hospital NHS Foundation Trust: Sophie Connor, Alexa King, Anar Shaikh, Dominic Carrington, Charles Amoah, Emerson Tingco, Jennette Elayba, Charlene Formento, Priya Dabasia, Soraya Al-Samarie, Kanom Bibi, Roel Cabellon, Christie Garcelales, Joel Real, Louis Wenigha, Martha Simango, Nafaz Illiyas, Elaina Reid, Paul Foster, Matt Kinsella, Edmore Ncube, Christine Fernandez, Hannah Williams, Evripidis Sykakis, Evangelia Gkaragkani, Roxanne Crosby-Nwaobi, Kirsty Chartier, Catherine Grigg, Panayiotis Panayiotou, Gaboitsiwe Maphango, Qin Neville, Anthony Khawaja, Karine Girard-Claudon, Nathan Kerr, Aberami Chandrakumar, Sash.Y Jeetun, Hamida Begum, Hannah Hounslow, Jasmeet Bahra, Hilary Swann, Katy Barnard, Gareth Davey, Cristina Citu, Ramona Berinde, Layla Juma, Jenny Elliot, Hayley Thomas, Tran Toan Dang, Shabneez Laulloo, Lucia Gonzalez, Minara Begum, Supeetha David, Hari Jayaram, Niraapha Sivakumaran, Tina Reetun, Sapna Shah, Diana Dabrickaite, Yusrah Shweikh, Priyansha Sheel, Ashish Mashru; Birmingham and Midland Eye Centre, Sandwell and West Birmingham Hospitals NHS Trust: Zain Juma, Richard Stead, Sue Southworth, Katie Atterbury, Esther Poole, Monica Hutton, Xicoli Chan, Patrick Chiam, Zoe Pilsworth, Risna Haq, Zahira Maqsood, Suaad Alasow, Melisa Fenton; Hairmyres Hospital, East Kilbride, NHS Lanarkshire: Anne McMurdo, Lesley Quigley, Elizabeth Shearer, Janice Simmons, Anne Moore, Karen Murray; Ninewells Hospital, Dundee, NHS Tayside: Heather Loftus, Michelle Robertson; York Teaching Hospital NHS Foundation Trust: Srilakshmi Gollapothu, Alison Grice-Holt, Gillian Ranson, Gary Lamont, Sara Stringer, Carol Sarginson, Christine O’Dwyer, Joanne Wincup; James Paget University Hospitals NHS Foundation Trust: Emma Stimpson, Lucy Hutchins, Tracy Duval, Lesley Parsons, Paula Head, Stephanie Cotton, Katie Riches, Amy Thanawalla, Katherine Mackintosh, Ellis Hinchley, Mya So; Imperial College Ophthalmology Research Group (ICORG), Western Eye Hospital, Imperial College Healthcare NHS Trust: Altaf Mamoojee, Zena Rodrigues, Eduardo Normando, Serge Miodragovic, Seham Jeylani, Paolo Bonetti, Jessica Bonetti.

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