Treatment of Advanced Glaucoma Study (TAGS): a multicentre randomised controlled trial comparing primary medical treatment with primary trabeculectomy for people with newly diagnosed advanced glaucoma

ottingham University Hospitals NHS Trust (UK)0 个研究点目标入组 453 人开始时间: 2014年1月14日最近更新: 2024年1月22日

试验速览

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29074496 protocol (added 02/04/2019) 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32006484 results (added 03/02/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33980505/ (added 17/05/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34854808/ (added 03/12/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36596663/ 24 month follow up (added 04/01/2023) 2024 Results article in https://doi.org/10.1016/j.ophtha.2024.01.007 5 year results (added 11/01/2024)

•1. Severe glaucomatous visual field loss (Hodapp classification) in one or both eyes at presentation
•2. Open angle glaucoma including pigment dispersion glaucoma, pseudoexfoliative glaucoma and normal tension glaucoma
•3. Willingness to participate in a trial
•4. Ability to provide informed consent
•5. Adult = 18 years
•6. Female participants of childbearing potential and male participants whose partner is of childbearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter. A negative urine pregnancy test for females of childbearing potential is required prior to randomisation

•1. Inability to undergo incisional surgery due to inability to lie flat or unsuitable for anaesthetic
•2. High risk of trabeculectomy failure such as previous conjunctival surgery or complicated cataract surgery
•3. Secondary glaucomas and primary angle-closure glaucoma
•4. Females who are pregnant, nursing or planning a pregnancy or females of childbearing potential not using a reliable method of contraception. A female is considered to be of childbearing potential unless she is without a uterus or is post-menopausal and has been amenorrheic for at least 12 consecutive months

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