Treatment of Advanced Glaucoma Study

Not Applicable

Completed

• Conditions: Adults with advanced glaucoma; Eye Diseases; Glaucoma

• Registration Number: ISRCTN56878850
• Lead Sponsor: ottingham University Hospitals NHS Trust (UK)

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-14
• Study Completion: 2020-01-31
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 453

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 experienceClinical:1. Visual field mean deviation (MD) changes2. Intraocular pressure (IOP)3. LogMAR visual acuity change (LVA)4. Need for cataract surgery5. Visual standards for driving6. Registered visual impairment7. SafetyEconomic:1. Incremental costs to NHS, personal social services and patients2. Incremental quality-adjusted life-years (QALYs) based on responses to EQ-5D, HUI-3 and glaucoma utility index