NCT03644875已完成不适用
A Prospective, Single Center, Non-comparative, 90-Day Follow-up, Postmarket Clinical Investigation of Etacoat in Patients With Cataract Surgery Via the Anterior Chamber
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Specular microscopy to measure the preservation of endothelium
研究概览
简要总结
This is a prospective, single center, non-comparative, 90-day follow-up, post-market clinical investigation of etacoat in patients undergoing cataract surgery.
The performance is evaluated by the preservation of endothelial cells measured by specular microscopy at the follow-up visit in comparison to baseline values.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients indicated for cataract surgery via the anterior chamber
- •A negative urine pregnany test at Visit 1 or 2
- •Capability to understand information about the investigation, including patients' obligations, and willingness to take part, as evidenced by signed and dated informed consent.
排除标准
- •Patient who are known to be hypersensitive to HPMC or other components of the device
- •Patients with corneal scars or corneal dystrophies interfering with study measurements
- •Abnormal intraocular pressure which would interfere with surgery and follow up (in opinion of the investigator)
- •Any other condition that in the opinion of the investigator would interfere with the participation in this investigation
- •Any person dependent on the investigator or employees of the investigation site institution or the Sponsor
- •Current or previous (within 30 days of enrollment) treatment with another investigational drug and/or medical device or participation in another clinical study
- •Patients whose participation in clinical trials is prohibited by the Austrian Medical Devices Act
结局指标
主要结局
Specular microscopy to measure the preservation of endothelium
时间窗: 90 days post surgery compared to baseline
次要结局
- Questionnaire to assess the satisfaction with the application(day 0)
- Specular microscopy to measure the corneal thickness(post surgery, 1 day and 90 days post surgery compared to baseline)
- Intraocular pressure measurement(post surgery, 1 day and 90 days post surgery compared to baseline)
研究者
研究点 (1)
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