NCT05885022招募中不适用
Feasibility Clinical Evaluation of the Calibreye System
Myra Vision Inc.7 个研究点 分布在 3 个国家目标入组 60 人开始时间: 2023年5月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- Intraocular Pressure
研究概览
简要总结
To evaluate the safety and feasibility of the Calibreye System in patients with open angle glaucoma.
详细描述
This is a prospective, nonrandomized, open-label feasibility clinical trial, to evaluate the surgical procedure, safety and effectiveness of the Calibreye System in reducing intraocular pressure in subjects with open angle glaucoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Open angle, pseudoexfoliative or pigmentary glaucoma
- •IOP at preoperative visit of ≥ 18mmHg and ≤ 45mmHg
- •Visual field mean deviation score of -3dB or worse
- •Area of healthy, free and mobile conjunctiva in the target quadrant
- •Shaffer angle grade ≥ 3 in the target quadrant
排除标准
- •Angle closure glaucoma
- •Congenital, neovascular or other secondary glaucomas
- •Previous intraocular surgery (with the exception of laser trabeculoplasty or uncomplicated phacoemulsification with IOL occurring > 3 months prior to the preoperative visit)
- •Previous glaucoma shunt/valve in the target quadrant
- •Clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit
- •History of corneal surgery, corneal opacities or corneal disease
- •Active diabetic retinopathy
结局指标
主要结局
Intraocular Pressure
时间窗: 12 Months
Percent change in IOP from baseline to the 12-month visit
Adverse Events
时间窗: 12 Months
Number and percentage of subjects having any adverse event
次要结局
- Glaucoma Medication Usage(12 Months)
研究者
研究点 (7)
Loading locations...
相似试验
已完成
3 期
A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular HypertensionOpen-Angle GlaucomaOcular HypertensionNCT00293800Alcon Research173
进行中（未招募）
不适用
MINIject (MINI SO627) in Patients With Open Angle Glaucoma Using Single Operator Delivery ToolGlaucoma, Open-Angle Glaucoma EyeNCT04517786iSTAR Medical21
已完成
3 期
A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular HypertensionOpen-angle GlaucomaOcular HypertensionNCT00293787Alcon Research156
已完成
不适用
Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Soft Contact Lens WearersMyopiaRefractive ErrorAstigmatismHyperopiaNCT01912768Alcon Research362
已完成
不适用
Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Gas Permeable Contact Lens WearersMyopiaAstigmatismRefractive ErrorHyperopiaNCT01912781Alcon Research112