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

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.Peer reviewedPublisher PD

Evaluating primary treatment for people presenting with advanced glaucoma: 5-year results of the Treatment of Advanced Glaucoma Study

Purpose: to determine whether primary trabeculectomy or medical treatment produces better outcomes in term of quality of life (QoL), clinical effectiveness and safety in patients presenting with advanced glaucoma. // Design: multicentre randomised controlled trial // Participants: between June 3, 2014 and May 31, 2017, 453 adults presenting with newly diagnosed advanced open angle glaucoma in at least one eye (Hodapp Classification) were recruited from 27 secondary care glaucoma departments in the UK, 227 were allocated to trabeculectomy and 226 to medical management. // Methods: participants were randomised on a 1:1 basis to have either mitomycin C augmented trabeculectomy or escalating medical management with intraocular pressure reducing drops as their primary intervention and followed up for 5 years. ISRCTN registry: ISRCTN56878850. // Main Outcome Measures: The primary outcome was vision-specific quality of life measured with Visual Function Questionnaire-25 (VFQ-25) at 5-years. Secondary outcomes: general health status, glaucoma related QoL, clinical effectiveness [intraocular pressure (IOP), visual field (VF), visual acuity (VA)] and safety. // Results: At 5 years the mean VFQ-25 in the trabeculectomy and medication arms were 83.3 (SD 15.5) and 81.3 (SD 17.5) respectively, mean difference 1.01, (95% CI -1.99 to 4.00); p=0.51. Mean IOPs were 12.07 ( 5.18) mmHg and 14.76 (4.14) mmHg respectively, mean difference -2.56 (95% CI -3.80 to -1.32); p<0.001. Glaucoma severity measured with visual field mean deviation were -14.30 (7.14) and -16.74 (6.78) dB respectively, mean difference 1.87 (95% CI 0.87 to 2.87) dB, p<0.001. Safety events occurred in 115 (52.2%) in the trabeculectomy arm and 124 (57.9%) in the medication arm, relative risk 0.92 (95% CI 0.72 to 1.19); p=0.54. Serious adverse events were rare. // Conclusion: At 5 years TAGS has demonstrated that primary trabeculectomy surgery is more effective in lowering IOP and preventing disease progression than primary medical treatment in patients presenting with advanced disease and has a similar safety profile // Trial registration: Health Technology Assessment (NIHR-HTA) Programme (Project number: 12/35/38). ISRCTN registry: ISRCTN56878850

Evaluating Primary Treatment for People with Advanced Glaucoma: Five-Year Results of the Treatment of Advanced Glaucoma Study.

PURPOSE: To determine whether primary trabeculectomy or medical treatment produces better outcomes in terms of quality of life (QoL), clinical effectiveness, and safety in patients with advanced glaucoma. DESIGN: Multicenter randomized controlled trial. PARTICIPANTS: Between June 3, 2014, and May 31, 2017, 453 adults with newly diagnosed advanced open-angle glaucoma in at least 1 eye (Hodapp classification) were recruited from 27 secondary care glaucoma departments in the United Kingdom. Two hundred twenty-seven were allocated to trabeculectomy, and 226 were allocated medical management. METHODS: Participants were randomized on a 1:1 basis to have either mitomycin C-augmented trabeculectomy or escalating medical management with intraocular pressure (IOP)-reducing drops as the primary intervention and were followed up for 5 years. MAIN OUTCOME MEASURES: The primary outcome was vision-specific QoL measured with the 25-item Visual Function Questionnaire (VFQ-25) at 5 years. Secondary outcomes were general health status, glaucoma-related QoL, clinical effectiveness (IOP, visual field, and visual acuity), and safety. RESULTS: At 5 years, the mean ± standard deviation VFQ-25 scores in the trabeculectomy and medication arms were 83.3 ± 15.5 and 81.3 ± 17.5, respectively, and the mean difference was 1.01 (95% confidence interval [CI], -1.99 to 4.00; P = 0.51). The mean IOPs were 12.07 ± 5.18 mmHg and 14.76 ± 4.14 mmHg, respectively, and the mean difference was -2.56 (95% CI, -3.80 to -1.32; P < 0.001). Glaucoma severity measured with visual field mean deviation were -14.30 ± 7.14 dB and -16.74 ± 6.78 dB, respectively, with a mean difference of 1.87 (95% CI, 0.87-2.87 dB; P < 0.001). Safety events occurred in 115 (52.2%) of patients in the trabeculectomy arm and 124 (57.9%) of patients in the medication arm (relative risk, 0.92; 95% CI, 0.72-1.19; P = 0.54). Serious adverse events were rare. CONCLUSIONS: At 5 years, the Treatment of Advanced Glaucoma Study demonstrated that primary trabeculectomy surgery is more effective in lowering IOP and preventing disease progression than primary medical treatment in patients with advanced disease and has a similar safety profile. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article

Evaluating primary treatment for people presenting with advanced glaucoma: 5-year results of the Treatment of Advanced Glaucoma Study

PurposeTo determine whether primary trabeculectomy or medical treatment produces better outcomes in terms of quality of life (QoL), clinical effectiveness, and safety in patients with advanced glaucoma.DesignMulticenter randomized controlled trial.ParticipantsBetween June 3, 2014, and May 31, 2017, 453 adults with newly diagnosed advanced open-angle glaucoma in at least 1 eye (Hodapp classification) were recruited from 27 secondary care glaucoma departments in the United Kingdom. Two hundred twenty-seven were allocated to trabeculectomy, and 226 were allocated medical management.MethodsParticipants were randomized on a 1:1 basis to have either mitomycin C-augmented trabeculectomy or escalating medical management with intraocular pressure (IOP)-reducing drops as the primary intervention and were followed up for 5 years.Main Outcome MeasuresThe primary outcome was vision-specific QoL measured with the 25-item Visual Function Questionnaire (VFQ-25) at 5 years. Secondary outcomes were general health status, glaucoma-related QoL, clinical effectiveness (IOP, visual field, and visual acuity), and safety.ResultsAt 5 years, the mean ± standard deviation VFQ-25 scores in the trabeculectomy and medication arms were 83.3 ± 15.5 and 81.3 ± 17.5, respectively, and the mean difference was 1.01 (95% confidence interval [CI], –1.99 to 4.00; P = 0.51). The mean IOPs were 12.07 ± 5.18 mmHg and 14.76 ± 4.14 mmHg, respectively, and the mean difference was –2.56 (95% CI, –3.80 to –1.32; P &lt; 0.001). Glaucoma severity measured with visual field mean deviation were –14.30 ± 7.14 dB and –16.74 ± 6.78 dB, respectively, with a mean difference of 1.87 (95% CI, 0.87–2.87 dB; P &lt; 0.001). Safety events occurred in 115 (52.2%) of patients in the trabeculectomy arm and 124 (57.9%) of patients in the medication arm (relative risk, 0.92; 95% CI, 0.72–1.19; P = 0.54). Serious adverse events were rare.ConclusionsAt 5 years, the Treatment of Advanced Glaucoma Study demonstrated that primary trabeculectomy surgery is more effective in lowering IOP and preventing disease progression than primary medical treatment in patients with advanced disease and has a similar safety profile