A Prospective Multicenter Study To Assess The Clinical Outcomes Of Current Phacoemulsification Approach To Cataract Extraction Versus The Micor System Device Using Low Energy Lens Extraction In Patients Undergoing Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 402
- 试验地点
- 12
- 主要终点
- UCVA Measurement
研究概览
简要总结
The purpose of this research study is to evaluate the clinical outcomes of current phacoemulsification approaches to cataract extraction involving high-frequency thermogenic energy versus the use of the MICOR System device using low-energy segment removal with a micro-interventional irrigation/aspiration port to evacuate the lens in subjects undergoing routine cataract surgery.
详细描述
This is prospective, multicenter, 3-arm study designed to provide longitudinal, observational, clinical outcome data for the use of traditional phacoemulsification for subjects undergoing cataract surgery versus the MICOR System device used to evacuate the lens prior to intraocular lens insertion and cataract surgery. Only FDA cleared phacoemulsification devices can be used per indications.
Both eyes of the study subjects may be enrolled into the study; however, if only 1 eye is eligible for study participation, then the eligible eye of the subject may be enrolled. Up to 750 eyes will be enrolled into one of three study groups, up to 250 subjects per group, with a maximum of 10 study centers. The 3 arms of the study groups are as follows:
- Group 1 Phaco subject cohort.
- Group 2 MICOR System subject cohort, non-use of miLOOP.
- Group 3 MICOR System subject cohort, use of miLOOP optional.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to understand study requirements, willing to follow study instructions and willing to return for required study follow-up visits.
- •Willing and able to understand and complete the informed consent document.
- •Subjects with a cataract grade of 1 to 4+ and are scheduled to undergo cataract surgery.
- •Subjects ≥ 18 years of age.
排除标准
- •Subjects, who in the opinion of the investigator, have "compromised" eye(s); no comorbidities and no patients undergoing concurrent corneal surgery with cataract extraction.
- •Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit.
- •Subjects that are pregnant, lactating or planning to become pregnant during the course of the study.
研究组 & 干预措施
Group 1 Phaco Subject Cohort
The Group 1 Phaco subject cohort will begin enrolling subjects sequentially in the first initial arm of the study with up to 250 eyes total.
干预措施: Phaco Subject Cohort (Device)
Group 2 miCOR System Subject Cohort
The Group 2 MICOR System subject cohort, non-use of miLOOP will enroll subsequently with up to 250 eyes total.
干预措施: miCOR System (Device)
Group 3 miCOR System Subject Cohort
The Group 3 MICOR System subject cohort, use of miLOOP optional will enroll subsequently with up to 250 eyes total.
干预措施: miCOR System (Device)
结局指标
主要结局
UCVA Measurement
时间窗: 1 day postoperative
1-Day postoperative UCVA measurement using LogMAR visual acuity charts
次要结局
未报告次要终点