ISRCTN96423140已完成未知
The United Kingdom Glaucoma Treatment Study
Moorfields Eye Hospital NHS Foundation Trust (UK)0 个研究点目标入组 686 人开始时间: 2006年12月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 686
研究概览
简要总结
- 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
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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