A Phaco ± LenSx® Procedure Patients Registry in Indian Tertiary Medical Centers
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
The purpose of this study is to record and analyze the profile and outcome of cataract patients receiving phacoemulsification (phaco) and artificial intraocular lens (IOL) implantation with or without femtosecond laser-assisted cataract surgery (FLACS) in Indian tertiary medical centers.
详细描述
Legitimate patients will receive Standard of Care (SOC) phacoemulsification treatment for cataract and IOL implantation, with or without using LenSx® technology, with followup for 1 month using SOC postsurgical treatment.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Agree to undergo phacoemulsification cataract surgery in at least 1 eye;
- •Understand and sign an informed consent form;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Refuse to sign the informed consent form or have incomplete medical records;
- •Contraindications for phacoemulsification treatment per Investigator discretion or listed in LenSx® Operator's Manual;
- •Contraindications for anterior capsulotomy, phacofragmentation of the lens using the FLACS;
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Best Corrected Visual Acuity (BCVA)
时间窗: Up to Day 30 postoperative
Uncorrected Visual Acuity (UCVA)
时间窗: Up to Day 30 postoperative
Completion rate of an anterior capsulotomy
时间窗: Day 0, operative day
Cumulative dissipated energy (CDE)
时间窗: Day 0, operative day
Cumulative Dissipated Energy (the amount of ultrasound energy entering the eye during the removal of the cataractous lens) will be reported on the Vision System interface and measured in percent-seconds.
Total phaco + IOL time
时间窗: Day 0, operative day
Aspiration fluid (ml)
时间窗: Day 0, operative day
Success rate of IOL insertion
时间窗: Day 0, operative day
Completion rate of cornea incision
时间窗: Day 0, operative day
Laser procedure time from suction on to off
时间窗: Day 0, operative day
次要结局
未报告次要终点