NCT02789293已完成不适用
Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients
EyeTechCare7 个研究点 分布在 4 个国家目标入组 80 人开始时间: 2016年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 7
- 主要终点
- Efficacy endpoint : Reduction of intraocular pressure
研究概览
简要总结
The purpose of the this study is to collect safety and efficacy data on Focused Ultrasound treatment (UCP procedure) in open angle glaucoma patients without previous glaucoma surgery.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Open Angle Glaucoma patient (Primary Open Angle Glaucoma (POAG) including Pigmentary Glaucoma (PG) and PseudoExfoliative Glaucoma (PXF))
- •Any patients without previous conventional glaucoma surgery failure (trabeculectomy, Deep Sclerectomy, Ahmed valve, drainage device implantation, cyclo cryotherapy, Diode laser cyclo-destruction)
- •Subjects where the IOP is not adequately controlled with glaucoma medication, with IOP ≥ 21 mm Hg and <30 mmHg
- •No previous intraocular surgery or laser treatment during the 90 days before HIFU Day
- •Age > 18 years and < 90 years
- •Patient able and willing to complete postoperative follow-up requirements
排除标准
- •Patient who has been diagnosed for normal tension glaucoma
- •Ocular or retrobulbar tumor
- •Ocular infection within 14 days prior to the HIFU procedure
- •Ocular disease other than glaucoma that may affect assessment of visual acuity and/or IOP (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy, proliferative diabetic retinopathy, clinically significant macular edema...)
结局指标
主要结局
Efficacy endpoint : Reduction of intraocular pressure
时间窗: 24 months
Reduction of intraocular pressure at 24 months relative to the preoperative value assessed at each follow-up visits with the final measurement of success at 24 months
次要结局
- Efficacy Endpoint : Mean IOP variation (%)(24 months)
- Safety : rate of per and post-operative complications/adverse effects(24 months)
- Efficacy endpoint : Mean IOP (mmHg)(24 months)
- Mean Number of ocular hypotensive medications(24 months)
研究者
研究点 (7)
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