NCT04866706已完成不适用
Performance and Safety of Routine Cataract Surgery With Visiol
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Corneal endothelial cells density in percent
研究概览
简要总结
In this clinical investigation, the performance and safety of routine cataract surgery with VISIOL will be assessed
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Male or female aged 18 years and older;
- •Candidate for cataract surgery via phacoemulsification;
- •Ophthalmic surgeon's recommendation to use VISIOL prior to recruitment;
- •Eligible for the use of VISIOL as indicated in the instructions for use;
- •Written informed consent.
排除标准
- •Known allergy or hypersensitivity to any of VISIOL components;
- •Known pregnancy or breast feeding;
- •Participation in any other clinical research study within the last 90 days;
- •Patients with legally restricted autonomy, freedom of decision and action (e.g. those with measure of custody or judicial protection);
- •Incapacity to understand the informed consent and/or to comply with the Clinical Investigation Plan (CIP), per investigator's appreciation.
结局指标
主要结局
Corneal endothelial cells density in percent
时间窗: Change from pre-surgery Corneal endothelial cells density at Day 1, Day 7, Day 30, Day 90
The variation of corneal endothelial cells density (cells/mm2) as compared to baseline (pre-surgery) will be calculated (%)
次要结局
未报告次要终点
研究者
研究点 (1)
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