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

Anthony J King; Jemma Hudson; Augusto Azuara-Blanco; Jennifer Burr; Ashleigh Kernohant; Tara Homer; Hosein Shabaninejad; John M Sparrow; David Garway-Heath; Keith Barton; John Norrie; Tracey Davidson; Luke Vale; Graeme MacLennan; TAGS Study Group

doi:10.1016/j.ophtha.2024.01.007

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

Anthony J King^* (Corresponding Author), Jemma Hudson, Augusto Azuara-Blanco, Jennifer Burr, Ashleigh Kernohant, Tara Homer, Hosein Shabaninejad, John M Sparrow, David Garway-Heath, Keith Barton, John Norrie, Tracey Davidson, Luke Vale, Graeme MacLennan, TAGS Study Group

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

Abstract

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.

Original language	English
Journal	Ophthalmology
Early online date	8 Jan 2024
DOIs	https://doi.org/10.1016/j.ophtha.2024.01.007
Publication status	E-pub ahead of print - 8 Jan 2024

Bibliographical note

Funding Information:
The author(s) have made the following disclosure(s): The TAGS was supported by a Grant from the National Institute of Health and Care Research - Health Technology Assessment Program - 12/35/38. J.H.: Financial support – National Institute for Health Research Health Technology Assessment Programme. A.K.: Financial support – National Institute for Health Research Health Technology Assessment Programme T.H.: Financial support – National Institute for Health Research Health Technology Assessment Programme H.S.: Financial support – National Institute for Health Research Health Technology Assessment Programme J.M.S.: Financial support – National Institute for Health Research Health Technology Assessment Programme D.G.-H.: Consultant – AbbVie, Omikron, Santen, Roche; Financial support – National Institute for Health Research Health Technology Assessment Programme and Efficacy and Mechanism Evaluation (EME) Programme, MRC DPFS, Horizon 2020, Janssen R&D LLC, Santen; Royalties – Heidelberg Engineering; Lecturer – Viatris, Omikron, Novartis, AbbVie; Patent – UCL, Cardiff/UCL, City University of London; Leadership or fiduciary role – European Glaucoma Society, Glaucoma Research Society, Investigative Ophthalmology and Visual Science K.B.: Consultant – iStar, EyeDPharma, Laboratoires Thea, Advanced Ophthamic Innovations, ELT Sight, Sight Sciences, Shifamed/Myra Medical, Tarsier Pharma, Radiance TX; Financial support – Advanced Ophthamic Innovations, AISG, Ahtens Glaucoma Congress, Moroccan Glaucoma Society, ARPS - Singapore; Lecturer – Alcon, Allergan, Laboratoires Thea, Santen Pharmaceutical Co. Ltd.; Patent – National University of Singapore; Leadership or fiduciary role – ELT Sight; Equity owner – Vision Futures Limited, Vision Medical Events Ltd., Aquesys, MedEther Ophthalmology, International Glaucoma Surgery Registry J.N.: Financial support – National Institute for Health Research L.V.: Financial support – National Institute for Health Research Health Technology Assessment Programme G.M.: Financial support – National Institute for Health Research Health Technology Assessment Programme and EME Programme Obtained funding: N/A

Keywords

Intraocular pressure
Open-angle glaucoma
Quality of life
Randomized controlled trial
Visual field loss

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Cite this

King, A. J., Hudson, J., Azuara-Blanco, A., Burr, J., Kernohant, A., Homer, T., Shabaninejad, H., Sparrow, J. M., Garway-Heath, D., Barton, K., Norrie, J., Davidson, T., Vale, L., MacLennan, G., & TAGS Study Group (2024). Evaluating Primary Treatment for People with Advanced Glaucoma: Five-Year Results of the Treatment of Advanced Glaucoma Study. Ophthalmology. Advance online publication. https://doi.org/10.1016/j.ophtha.2024.01.007

King, AJ, Hudson, J, Azuara-Blanco, A, Burr, J, Kernohant, A, Homer, T, Shabaninejad, H, Sparrow, JM, Garway-Heath, D, Barton, K, Norrie, J, Davidson, T, Vale, L, MacLennan, G & TAGS Study Group 2024, 'Evaluating Primary Treatment for People with Advanced Glaucoma: Five-Year Results of the Treatment of Advanced Glaucoma Study', Ophthalmology. https://doi.org/10.1016/j.ophtha.2024.01.007

@article{d765bcd5648e4c399c72b21732e67953,

title = "Evaluating Primary Treatment for People with Advanced Glaucoma: Five-Year Results of the Treatment of Advanced Glaucoma Study",

abstract = "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.",

keywords = "Intraocular pressure, Open-angle glaucoma, Quality of life, Randomized controlled trial, Visual field loss",

author = "King, {Anthony J} and Jemma Hudson and Augusto Azuara-Blanco and Jennifer Burr and Ashleigh Kernohant and Tara Homer and Hosein Shabaninejad and Sparrow, {John M} and David Garway-Heath and Keith Barton and John Norrie and Tracey Davidson and Luke Vale and Graeme MacLennan and {TAGS Study Group}",

note = "Funding Information: The author(s) have made the following disclosure(s): The TAGS was supported by a Grant from the National Institute of Health and Care Research - Health Technology Assessment Program - 12/35/38. J.H.: Financial support – National Institute for Health Research Health Technology Assessment Programme. A.K.: Financial support – National Institute for Health Research Health Technology Assessment Programme T.H.: Financial support – National Institute for Health Research Health Technology Assessment Programme H.S.: Financial support – National Institute for Health Research Health Technology Assessment Programme J.M.S.: Financial support – National Institute for Health Research Health Technology Assessment Programme D.G.-H.: Consultant – AbbVie, Omikron, Santen, Roche; Financial support – National Institute for Health Research Health Technology Assessment Programme and Efficacy and Mechanism Evaluation (EME) Programme, MRC DPFS, Horizon 2020, Janssen R&D LLC, Santen; Royalties – Heidelberg Engineering; Lecturer – Viatris, Omikron, Novartis, AbbVie; Patent – UCL, Cardiff/UCL, City University of London; Leadership or fiduciary role – European Glaucoma Society, Glaucoma Research Society, Investigative Ophthalmology and Visual Science K.B.: Consultant – iStar, EyeDPharma, Laboratoires Thea, Advanced Ophthamic Innovations, ELT Sight, Sight Sciences, Shifamed/Myra Medical, Tarsier Pharma, Radiance TX; Financial support – Advanced Ophthamic Innovations, AISG, Ahtens Glaucoma Congress, Moroccan Glaucoma Society, ARPS - Singapore; Lecturer – Alcon, Allergan, Laboratoires Thea, Santen Pharmaceutical Co. Ltd.; Patent – National University of Singapore; Leadership or fiduciary role – ELT Sight; Equity owner – Vision Futures Limited, Vision Medical Events Ltd., Aquesys, MedEther Ophthalmology, International Glaucoma Surgery Registry J.N.: Financial support – National Institute for Health Research L.V.: Financial support – National Institute for Health Research Health Technology Assessment Programme G.M.: Financial support – National Institute for Health Research Health Technology Assessment Programme and EME Programme Obtained funding: N/A ",

year = "2024",

month = jan,

day = "8",

doi = "10.1016/j.ophtha.2024.01.007",

language = "English",

journal = "Ophthalmology",

issn = "0161-6420",

publisher = "Elsevier Inc.",

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TY - JOUR

T1 - Evaluating Primary Treatment for People with Advanced Glaucoma

T2 - Five-Year Results of the Treatment of Advanced Glaucoma Study

AU - King, Anthony J

AU - Hudson, Jemma

AU - Azuara-Blanco, Augusto

AU - Burr, Jennifer

AU - Kernohant, Ashleigh

AU - Homer, Tara

AU - Shabaninejad, Hosein

AU - Sparrow, John M

AU - Garway-Heath, David

AU - Barton, Keith

AU - Norrie, John

AU - Davidson, Tracey

AU - Vale, Luke

AU - MacLennan, Graeme

AU - TAGS Study Group

N1 - Funding Information: The author(s) have made the following disclosure(s): The TAGS was supported by a Grant from the National Institute of Health and Care Research - Health Technology Assessment Program - 12/35/38. J.H.: Financial support – National Institute for Health Research Health Technology Assessment Programme. A.K.: Financial support – National Institute for Health Research Health Technology Assessment Programme T.H.: Financial support – National Institute for Health Research Health Technology Assessment Programme H.S.: Financial support – National Institute for Health Research Health Technology Assessment Programme J.M.S.: Financial support – National Institute for Health Research Health Technology Assessment Programme D.G.-H.: Consultant – AbbVie, Omikron, Santen, Roche; Financial support – National Institute for Health Research Health Technology Assessment Programme and Efficacy and Mechanism Evaluation (EME) Programme, MRC DPFS, Horizon 2020, Janssen R&D LLC, Santen; Royalties – Heidelberg Engineering; Lecturer – Viatris, Omikron, Novartis, AbbVie; Patent – UCL, Cardiff/UCL, City University of London; Leadership or fiduciary role – European Glaucoma Society, Glaucoma Research Society, Investigative Ophthalmology and Visual Science K.B.: Consultant – iStar, EyeDPharma, Laboratoires Thea, Advanced Ophthamic Innovations, ELT Sight, Sight Sciences, Shifamed/Myra Medical, Tarsier Pharma, Radiance TX; Financial support – Advanced Ophthamic Innovations, AISG, Ahtens Glaucoma Congress, Moroccan Glaucoma Society, ARPS - Singapore; Lecturer – Alcon, Allergan, Laboratoires Thea, Santen Pharmaceutical Co. Ltd.; Patent – National University of Singapore; Leadership or fiduciary role – ELT Sight; Equity owner – Vision Futures Limited, Vision Medical Events Ltd., Aquesys, MedEther Ophthalmology, International Glaucoma Surgery Registry J.N.: Financial support – National Institute for Health Research L.V.: Financial support – National Institute for Health Research Health Technology Assessment Programme G.M.: Financial support – National Institute for Health Research Health Technology Assessment Programme and EME Programme Obtained funding: N/A

PY - 2024/1/8

Y1 - 2024/1/8

N2 - 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.

AB - 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.

KW - Intraocular pressure

KW - Open-angle glaucoma

KW - Quality of life

KW - Randomized controlled trial

KW - Visual field loss

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U2 - 10.1016/j.ophtha.2024.01.007

DO - 10.1016/j.ophtha.2024.01.007

M3 - Article

C2 - 38199528

SN - 0161-6420

JO - Ophthalmology

JF - Ophthalmology

ER -

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

Abstract

Bibliographical note

Keywords

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