NCT02110212终止3 期
A Prospective, Randomized Study of Cataract Surgery With the Assistance of the OptiMedica Femtosecond Laser System Compared to Standard Surgical Procedure of Continuous Curvilinear Capsulorhexis and Ultrasonic Phacoemulsification
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 17
- 主要终点
- Capsulotomy Dimension
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy the OptiMedica Femtosecond Laser System, also known as the Catalys™ Precision Laser System, to perform two surgical maneuvers used in the treatment of subjects with cataracts. Efficacy will be evaluated by comparisons to the standard surgical procedure of continuous curvilinear capsulorhexis (CCC) and ultrasonic phacoemulsification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •ETDRS visual acuity equal to or worse than 20/32 (best corrected)
- •Age between 50 and 80 years old
- •Pupil dilates to at least 6 mm
- •Subject able to fixate
- •Grade 1-4 nuclear sclerotic cataract (LOCS III)
- •Axial length between 22 and 26 mm
排除标准
- •Pregnant, intending to become pregnant during course of the study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding
- •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 or for which cataract surgery is contraindicated
- •Anterior chamber depth (anterior corneal surface to anterior capsule margin) less than 2.5 mm via IOL Master (Zeiss).
- •History of prior ocular surgery
- •History of ocular trauma
- •Co-existing ocular disease affecting vision
- •History or current use of alpha-1 antagonist medication (e.g., Flomax)
- •Known sensitivity to planned concomitant medications
结局指标
主要结局
Capsulotomy Dimension
时间窗: Day of Surgery
Capsulotomy size will be measured during surgery for both the experimental and control groups.
次要结局
- Cumulative Dissipated Energy (CDE)(Day of Surgery)
研究者
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