Safety and Surgical Performance Study of Aurosleek Surgical Blades (Aurosleek)
A Prospective, Open Label, Observational Study To Evaluate The Safety And Surgical Performance Of Surgical Blade (Aurosleek) In Cataract Patients
研究概览
地位
条件
详细说明
研究类型
注册 (预期的)
联系人和位置
学习地点
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Tamilnadu
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Madurai、Tamilnadu、印度、625020
- 招聘中
- Aravind Eye Hospital
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接触:
- Neeraj Kumar Agrawal, MS
- 电话号码:181 04524356100
- 邮箱:agrawalneeraj84@gmail.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Senile cataract
- Willing to give written informed consent
- Ability to follow study instructions and likely to complete required visits.
Exclusion Criteria:
- Intraoperative complication including Posterior Capsular Rent and Zonular dialysis
- Traumatic cataract
- Uveitis and Complicated cataract
- One eyed patients
学习计划
研究是如何设计的?
设计细节
- 观测模型:仅案例
- 时间观点:预期
队列和干预
团体/队列 |
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Aurosleek blades
Patients having cataract will undergo surgery by using Aurosleek blades
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Physioclinical Characters
大体时间:30 days
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Assessment of physio-clinical characteristics of surgical blade such as handling of the blade, sharpness and smoothness of blade. Handling of the surgical blade will be assessed in grades of difficult to handle,easy to handle and very easy to handle intraoperatively. Sharpness and smoothness of the blade will be rated as poor or optimum while performing cataract surgery. |
30 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Post operative complications
大体时间:30 days
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The frequency and occurrence of post operative complications such as rhexis tear, posterior capsular rupture, severe corneal edema, severe iritis and anterior vitrectomy. Post operative complications occurrence due to surgical blade will be observed and graded as none or mild or moderate or severe at surgery and post operative 30 days. |
30 days
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合作者和调查者
赞助
调查人员
- 首席研究员:Neeraj Kumar Agrawal, MS、Medical Officer
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
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