Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 446
- 试验地点
- 1
- 主要终点
- Rate of capsule-ruptures due to Rx
研究概览
简要总结
The goal of this observationnal study is to supplement the data collected in the pre-market study and confirm the rate of capsular ruptures due to Rx (reducing its related confidence interval).
During cataract surgery, an artificial lens is placed into the capsular bag. The main question this study aims to answer is :
Is Rx use associated with a rate of caspular ruptures lower than 2% ? Medical records of participants having cataract surgery with Rx laser as part of their regular medical care will be assessed in order to answer the study objective.
详细描述
This study is a PMCF, sequential, non-interventional, prospective (follow-up: 30 ± 15 days), single-arm, single center, open trial.
Note: The design of this study is identical to the one of the Rx pre-market investigation (same design, same endpoints, same investigation site, same follow-up).
78 patients have been included in the pre-market investigation and will be used as part of dataset of the current PMCF study.
Sample size calculation (Wilson Method):
Considering the design of this study is identical to the one of the Rx pre-market investigation and that 78 patients have already been included in that pre-market clinical investigation (NCT05141370);
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Adult patients (age > 18 years);
- •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 confirmed their non-opposition to data collection
排除标准
- •Patient already operated with Rx for the first eye.
- •Any contra-indication to cataract surgery;
- •Patients with an ACD (Anterior Chamber Depth) less than 1.8mm and greater than 4.2mm;
- •Corneal disease or pathology that prevents corneal applanation or that may interfere with or hinder laser beam transmission;
- •Presence of blood or any other element that hinders the propagation of light between the epithelium and the anterior surface of the lens where the capsulotomy will be performed;
- •Weak pupil dilation or severely off-center pupil that prevents the iris from retracting adequately to the periphery (dilations < 6.5mm in diameter are excluded);
- •Abnormal tilt of the lens (> 7 degrees) ;
- •Significant preoperative ocular hypotonia or hypertonia;
- •Presence of an intra-corneal implant;
- •Active or unstabilized ocular surface disease including abnormal corneas (e.g., epithelial dystrophies,recurrent ulcers, infectious foci, conjunctivitis, severe dry syndromes);
- •History of lens disease or zonular instability;
- •Any perforating incision of the eyeball that may result in leakage during corneal applanation;
- •Presence of a limbal tumor obstacle that may interfere with stabilization of the device on the limbus: pterygium, limbal tumor, filter bubble, etc.
- •Patients under guardianship, trusteeship or deprived of liberty;
- •Patients unable to give their non-opposition for data collection for psychiatric, cognitive or linguistic reasons.
结局指标
主要结局
Rate of capsule-ruptures due to Rx
时间窗: During surgery
The investigator considers a rupture of the capsule will be Rx-related if: * There are peripheric tears that can generate the rupture of the capsule during or at the end of rhexis removal; * AND these tears generate the rupture of the capsule during surgery.
次要结局
- Continuity of the capsulorhexis (success / failure)(During surgery)
- Adverse device effects(During surgery, 4 days after surgery (4 ± 2 days), 30 days after surgery (30 ± 15 days))