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.
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 language | English |
|---|---|
| Pages (from-to) | 922-928 |
| Number of pages | 7 |
| Journal | British Journal of Ophthalmology |
| Volume | 102 |
| Issue number | 7 |
| Early online date | 26 Oct 2017 |
| DOIs | |
| Publication status | Published - Jul 2018 |
Bibliographical note
FundingNottingham 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).
Access to Document
- Treatment of Advanced Glaucoma Study
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