A Prospective Randomized Controlled Clinical Trial Comparing the Intra-operative Effects, Safety, Efficacy and Performance of Two Commercially Available Laser Systems in Patients Undergoing Femtosecond Laser-Assisted Cataract Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Cumulative Dissipated Energy
研究概览
简要总结
This study compares two FDA approved Cataract Lasers.
详细描述
The purpose of this study is to systematically evaluate the performance of two commercially available and FDA cleared femtosecond laser systems in patients undergoing femtosecond laser-assisted cataract surgery. Objective data on the repeatability and accuracy of the studied parameters will be gathered and reported as endpoints of the study.
The two systems studied are the Catalys™ Precision Laser System (OptiMedica, CA, USA) and the LenSx® Laser System (Alcon Laboratories, Inc., Fort Worth, TX).
Published data have suggested that the femtosecond laser is a useful tool for cataract surgery.
This study is to determine whether differences or similarities exist in specific treatment parameters achieved with two FDA cleared and commercially available femtosecond laser cataract surgery platforms
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have grade 2 to 4 nuclear sclerotic and or cortical or posterior subcapsular cataracts with visual impairment.
- •Pupillary dilation of at least 6.0 mm
- •Axial length between 21 mm to 26 mm
- •Age ≥ 22 years of either gender
- •Require laser assisted corneal incisions, capsulotomy and nucleus segmentation
- •Understand and sign a written Informed Consent form
- •Be able to comply with the treatment and follow-up schedule
排除标准
- •Enrolment in another drug or device study within the prior 3 months
- •History of ocular trauma
- •Acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised, etc.)
- •Uncontrolled systemic or ocular disease
- •Corneal abnormalities (e.g., stromal, epithelial or endothelial dystrophies, severe corneal opacities, significant corneal edema, etc)
- •Diminished aqueous clarity that obscures OCT imaging of the anterior lens capsule
- •Corneal ring and/or inlay implant(s)
- •Pseudoexfoliation
- •Known steroid IOP responder or ocular hypertension IOP >25 mmHg by tonometry
- •Retinal detachment within the last 6 months
- •Anterior chamber depth less than 2.5 mm
结局指标
主要结局
Cumulative Dissipated Energy
时间窗: Intraoperative
The total amount of phacoemulsification energy delivered during the procedure.
次要结局
- Complete Laser Capsulotomy(Intraoperative)
研究者
Steven H. Linn, OD
Study Coordinator
Hoopes Vision