Treatment of Advanced Glaucoma Study

Conditions

Adults with advanced glaucoma Eye Diseases Glaucoma

King AJ, Hudson J, Azuara-Blanco A, Kirwan JF, Goyal S, Lim KS, Maclennan G, TAGS research group.

2024-01-298 citations

10.1136/bjo-2022-321922

Primary trabeculectomy versus primary glaucoma eye drops for newly diagnosed advanced glaucoma: TAGS RCT

Anthony King, Gordon Fernie, Jemma Hudson, Ashleigh Kernohan, Augusto Azuara‐Blanco et al. (15 authors)

Health Technology Assessment2021-11-0120 citations

10.3310/hta25720

Primary trabeculectomy for advanced glaucoma: pragmatic multicentre randomised controlled trial (TAGS)

Anthony King, Jemma Hudson, Gordon Fernie, Ashleigh Kernohan, Augusto Azuara‐Blanco et al. (15 authors)

BMJ2021-05-1269 citations

10.1136/bmj.n1014

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 King, Gordon Fernie, Augusto Azuara‐Blanco, Jennifer Burr, David F. Garway‐Heath et al. (12 authors)

British Journal of Ophthalmology2017-10-2656 citations

10.1136/bjophthalmol-2017-310902

Interventions

The interventions being compared are: 1. primary trabeculectomy

2. primary medical treatment 1. Primary trabeculectomy: participants randomised to trabeculectomy will receive the standard trabeculectomy augmented with mitomycin-C. The definition of standard trabe

subsequent addition of medications is based on clinician judgement/preference. When drops fail to control intraocular pressure (IOP) adequately oral carbonic anhydrase inhibitors may be used. It i

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 18/09/2024: Patient-reported vision-specific health profile (NEI-VF Q25) evaluated at 2, 5 and 10 years Previous primary outcome measure: Patient-reported vision-specific health profile (NEI-VF Q25) evaluated at 24 months	—

Secondary

Measure	Time frame
Patient-centred: 1. Patient-reported health status as measured by EQ-5D (5-level), Health Utilities Index (HUI-3), Glaucoma Utility Index (GUI), National Eye Institute Visual Function Questionnaire (NEI-VF Q25) 2. Patient experience Clinical: 1. Visual field mean deviation (MD) changes 2. Intraocular pressure (IOP) 3. LogMAR visual acuity change (LVA) 4. Need for cataract surgery 5. Visual standards for driving 6. Registered visual impairment 7. Safety Economic: 1. Incremental costs to NHS, personal social services and patients 2. Incremental quality-adjusted life-years (QALYs) based on responses to EQ-5D, HUI-3 and glaucoma utility index	—

Measure

Time frame

Patient-centred: 1. Patient-reported health status as measured by EQ-5D (5-level), Health Utilities Index (HUI-3), Glaucoma Utility Index (GUI), National Eye Institute Visual Function Questionnaire (NEI-VF Q25) 2. Patient experience Clinical: 1. Visual field mean deviation (MD) changes 2. Intraocular pressure (IOP) 3. LogMAR visual acuity change (LVA) 4. Need for cataract surgery 5. Visual standards for driving 6. Registered visual impairment 7. Safety Economic: 1. Incremental costs to NHS, personal social services and patients 2. Incremental quality-adjusted life-years (QALYs) based on responses to EQ-5D, HUI-3 and glaucoma utility index

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Countries

England, United Kingdom

Outcome results

None listed