NCT07468409招募中不适用
Single-site, Open-label, Prospective Feasibility Study Performed Using the JASPER™ Robotic Surgical System in Cataract Surgery Procedures
ForSight Robotics Ltd1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年2月20日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Successful completion of planned Robotic-Assisted cataract surgery
研究概览
简要总结
This is a prospective, open-label clinical study designed to evaluate the performance and safety of the JASPER™ Robotic Surgical System during cataract surgery.
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
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Patient aged 55 to 80 years
- •Willing and able to sign an informed consent, attend the clinic and comply with all study procedures and the study protocol
- •Patients are scheduled to undergo cataract surgery
- •Clear intraocular media, other than cataract
- •Pupil dilate according to stand of care
排除标准
- •Prior ocular surgery or trauma in the study eye
- •Polar cataract in the study eye
- •Zonular instability or significant anterior segment abnormalities
- •Active ocular infection or uveitis
- •Pseudoexfoliation (PXF) syndrome in either eye
- •ASA Physical Status Classification > 3
- •Participation in another clinical trial within 30 days
研究组 & 干预措施
JASPER™ Robotic Surgical System
Experimental
Subjects will undergo cataract surgery using the JASPER™ Robotic Surgical System.
干预措施: JASPER™ Robotic Surgical System (Device)
结局指标
主要结局
Successful completion of planned Robotic-Assisted cataract surgery
时间窗: Intra-operative
Proportion of study eyes in which the planned robotic cataract surgery is completed using the JASPER™ Robotic Surgical System without conversion to manual technique.
次要结局
- Incidence and Type of Adverse Events (AEs) and Serious Adverse Events (SAEs)(From surgery through 30 days post-procedure)
- Distribution of pre and postoperative Best Corrected Visual acuity(Baseline and up to 30 days post-procedure)
- Postoperative Ophthalmic examination findings(Up to 30 days post-procedure)
研究者
研究点 (1)
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