The United Kingdom Glaucoma Treatment Study
- Conditions
- Eye DiseasesGlaucoma
- Registration Number
- ISRCTN96423140
- Lead Sponsor
- Moorfields Eye Hospital NHS Foundation Trust (UK)
- Brief Summary
1. 2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22986112 2. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24126032 3. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25533656 4. 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26393667 5. 2018 results in : https://www.ncbi.nlm.nih.gov/pubmed/29384083
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 686
1. 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 more than or equal to 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 two consecutive reliable post-screening VFs) of two or more contiguous points with P less than 0.01 loss or greater, or three or more contiguous points with P less than 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. Note: this differs from the Early Manifest Glaucoma Treatment (EMGT) criteria - Glaucoma Hemifield Test (GHT) outside normal limits in the same sector on two consecutive tests performed on different days, or GHT Borderline in the same sector on two consecutive tests performed on different days and obvious localised glaucomatous changes of the optic disc in an area corresponding to the field defect
2. Intraocular pressure: mean (screening and training visit) less than 30 mmHg, any intraocular pressure (IOP) less than 35 mmHg
3. Age: adult over 18 years (note: this differs from EMGT where the age range was 50 to 80 years of age)
4. Snellen visual acuity equal to or better than 6/12
5. Able to give informed consent and attend at the required frequency for the duration of the study
1. 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 less than 10 dB) in either eye (note: EMGT had no extra criteria for paracentral points)
2. Intraocular pressure more than 35 mmHg on two consecutive occasions in either eye
3. Unable to perform reliable visual field testing (less than 15% false positives, less than 20% fixation losses)
4. Unable to provide sufficient quality Heidelberg Retina Tomograph (HRT) images (mean pixel height standard deviation [MPHSD] less than 40 µm)
5. Cataractous lens gradings of more than N1, C2, or P1 according to Lens Opacities Classification System III (LOCS III)
6. Previous intraocular surgery (other than uncomplicated cataract extraction with posterior chamber lens implantation)
7. Cataract extraction with posterior chamber lens implantation within the last year
8. Diabetic retinopathy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The effectiveness of Latanoprost in reducing the frequency of progression events compared to placebo-treated eyes.
- Secondary Outcome Measures
Name Time Method 1. The identification of risk factors for progressive glaucoma<br>2. An evaluation of measurements of the rate of progression of glaucoma by measurement of ONH and RNFL structure with quantitative imaging technology, and of visual function with conventional perimetry. <br><br>It is anticipated that the use of rates of progression will enable improved study designs for subsequent clinical trials.