Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Continuity of the capsulorhexis (success / failure)
研究概览
简要总结
This study is a Pre-market first-in-man clinical investigation to validate performance of a hand-held femtosecond laser named CATSYS.
详细描述
Interventional, prospective, longitudinal (follow-up: 30 ± 10 days), single-arm, single center, open trial. The "first-in-man" character of this investigation relies on the ergonomics of CATSYS (handpiece), and not on the laser technique, which is similar to other FLACS.
The purpose of the clinical investigation is to document the compliance of the investigational medical device with the general requirements of performance, safety and clinical benefit, in order to complete existing data and obtaining CE-mark for CATSYS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Diagnosed with cataract requiring surgery according to current guidelines;
- •Eligible to lens removal by phacoemulsification and replacement by a prosthetic lens under local anesthesia;
- •Who have been informed and gave informed consent to participate in the study.
排除标准
- •Eye with an anterior chamber depth < 2.5 mm or > 3.8 mm;
- •Corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light;
- •Eye with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally;
- •Patient with residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease) in either eye;
- •History of steroid-responsive rise in IOP, glaucoma, or preoperative IOP>21 mm Hg in either eye;
- •Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, pseudoexfoliation syndrome, etc;
- •Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye;
- •Any recent penetrating incision of the eyeball;
- •Tilt of lens > 7;
- •Presence of any obstacle that may interfere with the stabilization of the device on the limbus: pterygium, limbic tumor, etc;
- •Pregnant or lactating woman;
- •Patient with any contra-indication to neosynephrine, tropicamide and oxybuprocaïne;
- •Patient presenting any contraindications to cataract surgery under local anesthesia (ex: allergy to anesthetic drops; neurodegenerative disease; schizophrenia; severe anxiety; etc.);
- •Patient who participates to another clinical trial (except observational studies), or in the exclusion period of another clinical trial;
- •Patient under guardianship, trusteeship or deprived of liberty;
- •Patient not affiliated to the French social security system;
- •Patient unable to participate in the study for psychiatric, cognitive or linguistic reasons.
结局指标
主要结局
Continuity of the capsulorhexis (success / failure)
时间窗: During surgery
Success achieved if: * the anterior capsule is completely cut (rhexis is free floating or easy to remove) * AND there are no peripheric tears that can generate the rupture of the capsule at the end of rhexis removal.
次要结局
- Adverse device effects(3 to 5 days after surgery)
- Ocular adverse events(30 ± 10 days post-surgery.)
- Adverse events(3 to 5 days post-surgery;)