Baseline characteristics of participants in the Treatment of Advanced Glaucoma Study : a multicenter randomized controlled trial
| Autor: | King, Anthony J., Hudson, Jemma, Fernie, Gordon, Burr, Jennifer, Azuara-Blanco, Augusto, Sparrow, John M., Barton, Keith, Garway-Heath, David F., Kernohan, Ashleigh, MacLennan, Graeme, TAGS Trial Group |
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| Přispěvatelé: | University of St Andrews. School of Medicine, University of St Andrews. Population and Behavioural Science Division |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_specialty Open angle glaucoma genetic structures medicine.medical_treatment MEDLINE Vision Disorders Visual Acuity NDAS Glaucoma Trabeculectomy RE Ophthalmology law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Quality of life law Sickness Impact Profile Glaucoma surgery medicine Humans Antihypertensive Agents Intraocular Pressure 030304 developmental biology Aged Aged 80 and over 0303 health sciences business.industry Middle Aged medicine.disease eye diseases Visual field Ophthalmology 030221 ophthalmology & optometry Physical therapy Quality of Life Female RE sense organs Visual Fields business Glaucoma Open-Angle |
| ISSN: | 5687-8850 |
| Popis: | Nottingham 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. 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 |
| Databáze: | OpenAIRE |
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