A Prospective, Open Label, Observational Study To Evaluate The Safety And Surgical Performance Of Surgical Blade (Aurosleek) In Cataract Patients
试验速览
- 阶段
- 不适用
- 发起方
- Aurolab
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Physioclinical Characters
研究概览
简要总结
To evaluate the safety and surgical effectiveness of surgical blades (Aurosleek) made by Aurolab.
详细描述
Cataract till today remains the most common yet treatable cause of blindness accounting for more than 50% of blindness and visual impairment in the developing world. One of the most important features of a blade for cataract surgery is its predictable and repeatable behavior. The surgeon repeatedly and reliably needs to create similar tunnels of the proper length. Aurolab is producing surgical blades (Aurosleek) intended for making incision in cataract surgeries.
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
- •Senile cataract
- •Willing to give written informed consent
- •Ability to follow study instructions and likely to complete required visits.
排除标准
- •Intraoperative complication including Posterior Capsular Rent and Zonular dialysis
- •Traumatic cataract
- •Uveitis and Complicated cataract
- •One eyed patients
结局指标
主要结局
Physioclinical Characters
时间窗: 30 days
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.
次要结局
- Post operative complications(30 days)