Danish Angle Closure Prevention Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 242
- 试验地点
- 10
- 主要终点
- Glaucoma
研究概览
简要总结
To determine whether primary angle closure suspects (PACS) in a Caucasian population benefit from prophylactic laser iridotomy.
详细描述
Prospective, randomised paired-eye design clinical trial comparing peripheral laser iridotomy in one eye with observation in the other over 5-years follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary angle closure suspect: ≥180 degrees (cumulative) irido-trabecular contact on darkroom gonioscopy, IOP<21mmHg, no peripheral anterior synechiae, no glaucomatous optic neuropathy
- •Best-corrected visual acuity (BCVA) >0.8 on both eyes
- •Caucasian
排除标准
- •Pseudophakia
- •Previous iridotomy
- •Clinically significant cataract with indication for surgery,
- •Unstable retinal conditions
- •Ocular malignancies
- •Systemic or ocular corticosteroid treatment
结局指标
主要结局
Glaucoma
时间窗: 5 year
The presence of glaucomatous optic neuropathy with visual field loss compatible with glaucoma. Glaucomatous optic neuropathy defined as loss of neuroretinal rim (notch or erosion), a vertical cup-to-disc ratio of more than 0.7, nerve fiber layer defect attributable to glaucoma, or both.
Acute Primary Angle Closure
时间窗: 5 year
Presence of at least 2 of the following symptoms: ocular or periocular pain; nausea, vomiting, or both; an antecedent history of intermittent blurring of vision with haloes and IOP of more than 30 mmHg and presence of at least 3 of the following signs: conjunctival injection, corneal epithelial edema, mid-dilated unreactive pupil, glaukomflecken, and shallow anterior chamber;
Intraocular pressure
时间窗: 5 year
GAT: ≥24mmHg or ≥22mmHg on two separate occasions
次要结局
未报告次要终点