Baseline characteristics of participants in the Treatment of Advanced Glaucoma Study : a multicenter randomized controlled trial
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Purpose To report the baseline characteristics of participants enrolled in TAGS (Treatment of Advanced Glaucoma Study). Design Pragmatic randomized control trial (RCT). Methods Participants with newly diagnosed advanced glaucoma in at least 1 eye were recruited. Participants were patients with open angle glaucoma presenting with advanced glaucoma in at least 1 eye as defined by the Hodapp-Parrish-Anderson (HPA) criteria for severe defect. Participants were randomly allocated to receive either primary augmented trabeculectomy or primary medical management. When both eyes were eligible, the same intervention was undertaken in both eyes, and the index eye for analysis was the eye with the less severe visual field mean defect (MD). Main outcome measurements were visual field profile, defined by the HPA classification; clinical characteristics; quality of life, as measured by the National Eye Institute Visual Function Questionnaire 25 (VFQ-25), the EuroQual-5 Dimension (EQ-5D 5L), Health Utility Index-3 (HUI-3), and the Glaucoma Profile Instrument (GPI). Results A total of 453 patients were recruited. The mean visual field MD was −15.0 dB ± 6.3 in the index eye and −6.2 dB in the non-index eye. Of index eyes (HPA “severe” classification) at baseline, more than 70% of participants had a MD <−12.00 dB, and nearly 90% had more than 20 points defective at the 1% level. The mean LogMAR visual acuity of the index eye was 0.2 ± 0.3. Conclusions TAGS is the first RCT to compare medical versus surgical treatments for patients presenting with advanced open angle glaucoma in a publicly funded health service. The study will provide clinical, health-related quality of life, and economic outcomes to inform future treatment choices for those presenting with advanced glaucoma.
King , A J , Hudson , J , Fernie , G , Burr , J , Azuara-Blanco , A , Sparrow , J M , Barton , K , Garway-Heath , D F , Kernohan , A , MacLennan , G & TAGS Trial Group 2020 , ' Baseline characteristics of participants in the Treatment of Advanced Glaucoma Study : a multicenter randomized controlled trial ' , American Journal of Ophthalmology , vol. 213 , pp. 186-194 . https://doi.org/10.1016/j.ajo.2020.01.026
American Journal of Ophthalmology
Copyright © 2020 Published by Elsevier. This work has been made available online in accordance with publisher policies or with permission. Permission for further reuse of this content should be sought from the publisher or the rights holder. This is the author created accepted manuscript following peer review and may differ slightly from the final published version. The final published version of this work is available at https://doi.org/10.1016/j.ajo.2020.01.026.
DescriptionNottingham University Hospitals NHS Trust sponsored the trial and provided the necessary trial insurance. The trial was funded by a grant from the National Institute for Health Research Health Technology Assessment (NIHR HTA) program (project number 12/35/38), trial registration number ISRCTN56878850. Disclaimer: The views expressed are those of the authors and not necessarily those of the National Health Service (NHS), the NIHR or the Department of Health. Ethics approval: the study adhered to the tenets of the Declaration of Helsinki and the principles of Good Clinical Practice and was carried out in accordance with all applicable regulatory guidance, including but not limited to the Research Governance Framework. TAGS′ protocol and patient-facing documentation were prospectively reviewed and approved by the Derby 1 Research Ethics Committee (ref number 13/EM/00395). Local NHS Research and Development (R&D) approvals were obtained prior to commencement of the trial at the participating sites. An independent data and safety monitoring committee oversees.
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