TY - JOUR
T1 - Primary trabeculectomy for advanced glaucoma
T2 - pragmatic multicentre randomised controlled trial (TAGS)
AU - King, Anthony
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 - Azuara-Blanco, Augusto
AU - Sidiki, Sikander
AU - TAGS Study Group
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. The funders had no role in considering the study design or in the collection, analysis, or interpretation of data; writing the report; or the decision to submit the article for publication. The views expressed herein are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.
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.
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
VL - 373
JO - BMJ
JF - BMJ
SN - 0959-8146
M1 - n1014
ER -