NCT01282346已完成不适用
Clinical Evaluation of the SOLX Gold Shunt for the Reduction of Intraocular Pressure (IOP) in Refractory Glaucoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- SOLX, Inc.
- 入组人数
- 116
- 试验地点
- 32
- 主要终点
- Proportion of eyes that achieve an IOP of > 5mmHg and ≤ 21 mmHg, irrespective of medication use
研究概览
简要总结
To establish the clinical performance of the SOLX Gold Shunt for its ability to reduce intraocular pressure (IOP) in eyes with refractory glaucoma where medical and conventional surgical treatments have failed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary open-angle glaucoma
- •age 21 or over
- •refractory glaucoma, with IOP ≥ 24 mmHg on medications and failed prior incisional glaucoma surgery
- •detectable visual field defect (negative MD score)
- •written informed consent
- •available for up to 24 months follow-up
排除标准
- •either eye with VA worse than count fingers
- •angle closure glaucoma episode within past 12 months
- •uveitic glaucoma, iridocorneal endothelial (ICE) syndrome, traumatic glaucoma, or neovascular glaucoma
- •diagnosis of pigmentary glaucoma or pseudoexfoliative glaucoma
- •other significant ocular disease, except cataract
- •active ocular infection
- •expected ocular surgery in next 12 months
- •no suitable quadrant for implant
- •systemic corticosteroid therapy > 5 mg/day prednisone
- •intolerance to gonioscopy or other eye exams
- •mental impairment interfering with consent or compliance
- •pregnancy
- •known sensitivity to anticipated medications used at surgery
- •significant co-morbid disease
- •concurrent enrollment in another drug or device study
结局指标
主要结局
Proportion of eyes that achieve an IOP of > 5mmHg and ≤ 21 mmHg, irrespective of medication use
时间窗: 1 year
次要结局
- Percentage change in IOP from baseline(1 & 2 years)
- Average change in IOP(1 & 2 years)
- Average change in number of glaucoma medications(1 & 2 years)
- Visual acuity changes(1 & 2 years)
研究者
研究点 (32)
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