Treatment of Advanced Glaucoma Study: a multicentre randomised controlled trial comparing primary medical treatment with primary trabeculectomy for people with newly diagnosed advanced glaucoma—study protocol

Anthony J. King, Gordon Fernie, Augusto Azuara-Blanco, Jennifer M. Burr, Ted Garway-Heath, John M. Sparrow, Luke Vale, Jemma Hudson, Graeme MacLennan, Alison Mary McDonald, Keith Barton, John Norrie

Research output: Contribution to journalArticle

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Abstract

Background: Presentation with advanced glaucoma is the major risk factor for lifetime blindness. Effective intervention at diagnosis is expected to minimise risk of further visual loss in this group of patients.
Aim: To compare clinical and cost effectiveness of primary medical management compared with primary surgery for people presenting with advanced open angle glaucoma (OAG).
Methods: Design: A prospective, pragmatic multi-centre randomised controlled trial (RCT).
Setting: Twenty seven UK hospital eye services.
Participants: Four hundred and forty patients presenting with advanced OAG, according to the Hodapp-Parish-Anderson classification of visual field loss.
Intervention: Participants will be randomized to medical treatment or augmented trabeculectomy (1:1 allocation minimised by centre and presence of advanced disease in both eyes).
Main Outcome Measures: The primary outcome is vision-related quality of life (QoL) measured by the National Eye Institute - Visual Function Questionnaire-25 at 24 months. Secondary outcomes include generic EQ-5D-5L, Health Utility Index-3 (HUI-3)] and glaucoma related health status [Glaucoma Utility Index (GUI)], patient experience, visual field measured by mean deviation value, LOGmar visual acuity, intraocular pressure, adverse events, standards for driving and eligibility for blind certification. Incremental cost per Quality Adjusted Life year (QALY) based on EQ-5D-5L and GPI will be estimated.
Results: The study will report the comparative effectiveness and cost-effectiveness of medical treatment against augmented trabeculectomy in a patients presenting with advanced glaucoma in terms of patient reported health and visual function, clinical outcomes and incremental cost per QALY at two-years.
Conclusions: TAGS will be the first RCT reporting outcomes from the perspective of those with advanced glaucoma.
Original languageEnglish
Pages (from-to)922-928
Number of pages7
JournalBritish Journal of Ophthalmology
Volume102
Issue number7
Early online date26 Oct 2017
DOIs
Publication statusPublished - Jul 2018

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Trabeculectomy
Glaucoma
Multicenter Studies
Randomized Controlled Trials
Quality-Adjusted Life Years
Open Angle Glaucoma
Visual Fields
Cost-Benefit Analysis
Eligibility Determination
National Eye Institute (U.S.)
Therapeutics
Costs and Cost Analysis
Health
Blindness
Intraocular Pressure
Health Status
Visual Acuity
Quality of Life
Outcome Assessment (Health Care)

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Treatment of Advanced Glaucoma Study : a multicentre randomised controlled trial comparing primary medical treatment with primary trabeculectomy for people with newly diagnosed advanced glaucoma—study protocol. / King, Anthony J.; Fernie, Gordon; Azuara-Blanco, Augusto; Burr, Jennifer M.; Garway-Heath, Ted; Sparrow, John M.; Vale, Luke; Hudson, Jemma; MacLennan, Graeme; McDonald, Alison Mary; Barton, Keith; Norrie, John.

In: British Journal of Ophthalmology, Vol. 102, No. 7, 07.2018, p. 922-928.

Research output: Contribution to journalArticle

King, Anthony J. ; Fernie, Gordon ; Azuara-Blanco, Augusto ; Burr, Jennifer M. ; Garway-Heath, Ted ; Sparrow, John M. ; Vale, Luke ; Hudson, Jemma ; MacLennan, Graeme ; McDonald, Alison Mary ; Barton, Keith ; Norrie, John. / Treatment of Advanced Glaucoma Study : a multicentre randomised controlled trial comparing primary medical treatment with primary trabeculectomy for people with newly diagnosed advanced glaucoma—study protocol. In: British Journal of Ophthalmology. 2018 ; Vol. 102, No. 7. pp. 922-928.
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abstract = "Background: Presentation with advanced glaucoma is the major risk factor for lifetime blindness. Effective intervention at diagnosis is expected to minimise risk of further visual loss in this group of patients. Aim: To compare clinical and cost effectiveness of primary medical management compared with primary surgery for people presenting with advanced open angle glaucoma (OAG).Methods: Design: A prospective, pragmatic multi-centre randomised controlled trial (RCT).Setting: Twenty seven UK hospital eye services. Participants: Four hundred and forty patients presenting with advanced OAG, according to the Hodapp-Parish-Anderson classification of visual field loss. Intervention: Participants will be randomized to medical treatment or augmented trabeculectomy (1:1 allocation minimised by centre and presence of advanced disease in both eyes).Main Outcome Measures: The primary outcome is vision-related quality of life (QoL) measured by the National Eye Institute - Visual Function Questionnaire-25 at 24 months. Secondary outcomes include generic EQ-5D-5L, Health Utility Index-3 (HUI-3)] and glaucoma related health status [Glaucoma Utility Index (GUI)], patient experience, visual field measured by mean deviation value, LOGmar visual acuity, intraocular pressure, adverse events, standards for driving and eligibility for blind certification. Incremental cost per Quality Adjusted Life year (QALY) based on EQ-5D-5L and GPI will be estimated.Results: The study will report the comparative effectiveness and cost-effectiveness of medical treatment against augmented trabeculectomy in a patients presenting with advanced glaucoma in terms of patient reported health and visual function, clinical outcomes and incremental cost per QALY at two-years.Conclusions: TAGS will be the first RCT reporting outcomes from the perspective of those with advanced glaucoma.",
author = "King, {Anthony J.} and Gordon Fernie and Augusto Azuara-Blanco and Burr, {Jennifer M.} and Ted Garway-Heath and Sparrow, {John M.} and Luke Vale and Jemma Hudson and Graeme MacLennan and McDonald, {Alison Mary} and Keith Barton and John Norrie",
note = "Funding Nottingham University Hospitals NHS Trust sponsors the trial and provides the necessary trial insurance. The trial is funded by a grant awarded by the Health Technology Assessment (NIHR HTA) programme (project number 12/35/38).",
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T1 - Treatment of Advanced Glaucoma Study

T2 - a multicentre randomised controlled trial comparing primary medical treatment with primary trabeculectomy for people with newly diagnosed advanced glaucoma—study protocol

AU - King, Anthony J.

AU - Fernie, Gordon

AU - Azuara-Blanco, Augusto

AU - Burr, Jennifer M.

AU - Garway-Heath, Ted

AU - Sparrow, John M.

AU - Vale, Luke

AU - Hudson, Jemma

AU - MacLennan, Graeme

AU - McDonald, Alison Mary

AU - Barton, Keith

AU - Norrie, John

N1 - Funding Nottingham University Hospitals NHS Trust sponsors the trial and provides the necessary trial insurance. The trial is funded by a grant awarded by the Health Technology Assessment (NIHR HTA) programme (project number 12/35/38).

PY - 2018/7

Y1 - 2018/7

N2 - Background: Presentation with advanced glaucoma is the major risk factor for lifetime blindness. Effective intervention at diagnosis is expected to minimise risk of further visual loss in this group of patients. Aim: To compare clinical and cost effectiveness of primary medical management compared with primary surgery for people presenting with advanced open angle glaucoma (OAG).Methods: Design: A prospective, pragmatic multi-centre randomised controlled trial (RCT).Setting: Twenty seven UK hospital eye services. Participants: Four hundred and forty patients presenting with advanced OAG, according to the Hodapp-Parish-Anderson classification of visual field loss. Intervention: Participants will be randomized to medical treatment or augmented trabeculectomy (1:1 allocation minimised by centre and presence of advanced disease in both eyes).Main Outcome Measures: The primary outcome is vision-related quality of life (QoL) measured by the National Eye Institute - Visual Function Questionnaire-25 at 24 months. Secondary outcomes include generic EQ-5D-5L, Health Utility Index-3 (HUI-3)] and glaucoma related health status [Glaucoma Utility Index (GUI)], patient experience, visual field measured by mean deviation value, LOGmar visual acuity, intraocular pressure, adverse events, standards for driving and eligibility for blind certification. Incremental cost per Quality Adjusted Life year (QALY) based on EQ-5D-5L and GPI will be estimated.Results: The study will report the comparative effectiveness and cost-effectiveness of medical treatment against augmented trabeculectomy in a patients presenting with advanced glaucoma in terms of patient reported health and visual function, clinical outcomes and incremental cost per QALY at two-years.Conclusions: TAGS will be the first RCT reporting outcomes from the perspective of those with advanced glaucoma.

AB - Background: Presentation with advanced glaucoma is the major risk factor for lifetime blindness. Effective intervention at diagnosis is expected to minimise risk of further visual loss in this group of patients. Aim: To compare clinical and cost effectiveness of primary medical management compared with primary surgery for people presenting with advanced open angle glaucoma (OAG).Methods: Design: A prospective, pragmatic multi-centre randomised controlled trial (RCT).Setting: Twenty seven UK hospital eye services. Participants: Four hundred and forty patients presenting with advanced OAG, according to the Hodapp-Parish-Anderson classification of visual field loss. Intervention: Participants will be randomized to medical treatment or augmented trabeculectomy (1:1 allocation minimised by centre and presence of advanced disease in both eyes).Main Outcome Measures: The primary outcome is vision-related quality of life (QoL) measured by the National Eye Institute - Visual Function Questionnaire-25 at 24 months. Secondary outcomes include generic EQ-5D-5L, Health Utility Index-3 (HUI-3)] and glaucoma related health status [Glaucoma Utility Index (GUI)], patient experience, visual field measured by mean deviation value, LOGmar visual acuity, intraocular pressure, adverse events, standards for driving and eligibility for blind certification. Incremental cost per Quality Adjusted Life year (QALY) based on EQ-5D-5L and GPI will be estimated.Results: The study will report the comparative effectiveness and cost-effectiveness of medical treatment against augmented trabeculectomy in a patients presenting with advanced glaucoma in terms of patient reported health and visual function, clinical outcomes and incremental cost per QALY at two-years.Conclusions: TAGS will be the first RCT reporting outcomes from the perspective of those with advanced glaucoma.

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DO - 10.1136/bjophthalmol-2017-310902

M3 - Article

VL - 102

SP - 922

EP - 928

JO - British Journal of Ophthalmology

JF - British Journal of Ophthalmology

SN - 0007-1161

IS - 7

ER -