The UK Glaucoma Treatment Study

Phase 1

• Conditions: Primary open-angle Glaucoma Pseudoexfoliation Glaucoma; MedDRA version: 20.0Level: LLTClassification code 10037118Term: Pseudoexfoliation glaucomaSystem Organ Class: 100000004853; Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]

• Registration Number: EUCTR2006-000653-22-GB
• Lead Sponsor: Moorfields Eye Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-23
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 648

Inclusion Criteria

Inclusion criteria a) Newly detected, previously untreated open-angle glaucoma (including primary open-angle glaucoma, normal tension glaucoma and pseudoexfoliation glaucoma) in either eye. Glaucoma is defined as: reproducible glaucomatous visual field (VF) defects in at least one eye with corresponding damage to the optic nerve head (cup disc ratio > or = 0.7 and/or focal narrowing of the neural rim) and in the absence of retinal or neurological condition that may account for the VF loss. A glaucomatous VF is defined as a reproducible defect (in at least 2 consecutive reliable post-screening VFs) of two or more contiguous points with P < 0.01 loss or greater, or three or more contiguous points with P < 0.05 loss or greater, or a 10-dB difference across the nasal horizontal midline at two or more adjacent points in the total deviation plot.36 b) Intraocular pressure: mean (screening and training visit) less than 30mmHg, any IOP <35mmHg c) Age: adult (over 16 years – UK Clinical Trials Regulations 2004) Note: this differs from EMGT where the age range was 50 to 80 years of age d) Snellen visual acuity better than 6/12 e) Able to give informed consent and attend at the required frequency for the duration of the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 324
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 324

Exclusion Criteria

Exclusion criteria a) Moderately advanced visual field loss (mean deviation worse than -10dB in the better eye or worse than -16 dB in the other eye) or a threat to fixation (paracentral point total sensitivity < 10dB) in either eye Note: EMGT had no extra criteria for paracentral points b) Intraocular pressure > 35mmHg on two consecutive occasions in either eye c) Unable to perform reliable visual field testing (<15% false positives, <25% false negatives, <25% fixation losses) d) Unable to provide sufficient quality HRT images (MPHSD <35?m) e) Cataractous lens gradings of more than N1, C2, or P1 according to LOCS II f) Previous intraocular surgery (other than uncomplicated cataract extraction with posterior chamber lens implantation) g) Cataract extraction with posterior chamber lens implantation within the last year h) Diabetic retinopathy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified