A Study of Cataract Surgery With the Assistance of the Femtosecond Laser
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 100
- 主要终点
- Capsulotomy Size
研究概览
简要总结
The purpose of this study is to evaluate the feasibility of using the Femtosecond Laser System to perform surgical maneuvers during cataract extraction 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
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to comply with the treatment/follow-up schedule and requirements
- •Able to understand and provide written Informed Consent
- •3. ETDRS visual acuity equal to or worse than 20/30 (best corrected)
- •Patient age between 50 and 80 years old
- •Pupil dilates to at least 8 mm
- •Patient able to fixate
- •1-3+ nuclear sclerotic cataract(This criterion does not apply to subjects who will receive post-IOL corneal relaxing incisions)
- •Axial length between 22 and 26 mm
排除标准
- •Pregnant, intending to become pregnant during course of study, less than 3 months postpartum or less than 6 weeks after completion of breast feeding
- •Participation in a study of another device or drug within 3 months prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria
- •Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study
- •Anterior chamber depth less than 2.5 mm via Optical Coherence Tomography (Visante, Zeiss) or IOL Master (Zeiss) measurements
- •History of prior ocular surgery
- •History of ocular trauma
- •Co-existing ocular disease affecting vision
- •Astigmatism greater than five diopters (D.)
研究组 & 干预措施
FS Laser Surgery
For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the OptiMedica Catalys™ Precision Laser System (Catalys System)
干预措施: FS Laser Surgery (Procedure)
FS Laser Surgery
For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the OptiMedica Catalys™ Precision Laser System (Catalys System)
干预措施: FS Laser System (Device)
结局指标
主要结局
Capsulotomy Size
时间窗: Day of Surgery
Capsulotomy size will be measured during surgery.
次要结局
- Cumulated Dissipated Energy (CDE)(Day of surgery)