Clinical Investigation of the Next Generation Phaco System (VERITAS Vision System)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 3
- 主要终点
- Proportion of Eyes With Surgeon Satisfaction Rating Score of 4 or 5
研究概览
简要总结
This study is a prospective, open-label clinical study of the VERITAS Vision System.
The study will be conducted at up to three sites, with minimum 55 eyes and up to 150 eyes to be treated. The investigator or designee will perform the cataract surgery with the VERITAS Vision System on the subjects. The data from the system log files, the questionnaire, the operative report and other medical records will be used to assess the clinical utilization of the VERITAS Vision System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Minimum 22 years of age.
- •Cataracts for which cataract extraction and posterior chamber IOL implantation have been planned.
- •Availability, willingness, ability and sufficient cognitive awareness to comply with study requirements, examination procedures, and visits.
- •Be willing to provide informed consent and authorization to disclose protected health information or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical procedures in the governing countries.
排除标准
- •Expected surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled intraocular pressure change, or significant vitreous prolapse or loss).
- •Subjects with only one good eye (e.g. amblyopic condition etc.).
- •Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects.
- •History or current use of alpha-1 antagonist medication (e.g., Flomax).
- •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.
- •Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils).
- •Is pregnant, or is breast feeding, or intend to become pregnant during the study.
- •Concurrent participation or expected participation in an interventional (i.e., surgical or pharmaceutical interventional) clinical trial within 14 days prior to study screening.
结局指标
主要结局
Proportion of Eyes With Surgeon Satisfaction Rating Score of 4 or 5
时间窗: 1 day postoperative
Surgeons rated the following Questionnaire items regarding satisfaction with the VERITAS Vision System, using 1 - 5 scale (acceptability considered favorable for scores of 4 and 5, where 4 is Satisfied and 5 is Very Satisfied)
次要结局
未报告次要终点