A Prospective Multicenter Study to Assess The Clinical Outcomes of Low Energy Lens Fragmentation Cataract Extraction in Patients Undergoing Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Total Lens Removal Time
研究概览
简要总结
The purpose of this research study is to evaluate the clinical outcomes of the use of low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion in subjects undergoing routine cataract surgery.
详细描述
Up to 300 eyes at up to 5 investigational sites will be enrolled in one of the two cohorts of this clinical investigation - up to 50 eyes in Cohort 1 and up to 50 eyes in Cohort 2. Only one eye per subject will be enrolled into the study. This is multicenter, multi-cohort, prospective clinical study designed to provide longitudinal, observational, non-comparative clinical outcome data for mechanical non-phacoemulsification lens extraction using low-energy segment removal with a micro-interventional irrigation/aspiration port (MICOR-304) to evacuate the lens prior to intraocular lens insertion.
Participants who meet the inclusion and exclusion will be asked to enroll in the study. The investigator or designee will explain the study purpose, procedures and responsibilities to the potential participant and provide sufficient opportunity to ask questions, while allowing adequate time for consideration of the information provided. Upon participant confirmation of interest, written informed consent will be obtained and the subject will be enrolled in the study. One copy of the informed consent document (ICD) will be retained with the subject's medical records and one copy will be provided to the subject.
Study subjects will be stratified into two Cohorts. Cohort 1 is comprised of eyes with mild-to- moderate cataracts only (Grade 1 to 2). Cohort 2 is comprised of eyes with moderate to more dense cataracts only (Grade 2+ to 3+).
Subjects will be seen at the screening visit, intraoperative visit, and at post-operative days 1, 7, and 30.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 3+ and are scheduled to undergo cataract surgery
- •Subjects ≥ 18 years of age
- •Clear intraocular media, other than cataract
排除标准
- •Polar cataracts
- •Zonular instability
- •History of dry eye treatments/devices and or dry eye medications other than artificial tears.
- •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
结局指标
主要结局
Total Lens Removal Time
时间窗: Assessed during the surgical procedure, measured in seconds.
Total lens removal time is defined in two phases: * The beginning time starts when the surgeon enters the eye with the MICOR-304 to start the lens removal process and completing when the surgeon finishes the nucleus lens removal with the MICOR-304 before changing over to irrigation and aspiration. * The second phase of lens removal time is the irrigation and aspiration stage for cortex removal which starts when the irrigation and aspiration tip enters the eye and completion time is when the cortex is removed. The total lens removal time as defined above is recorded in minutes and seconds.
Amount of Irrigation Solution Fluid Volume Used During the Surgical Procedure
时间窗: Assessed during the surgical procedure, approximately 8 - 10 minutes.
Total irrigation solution volume will be recorded using the indicators on the bag which will have labels that have pre-defined markers to indicate milliliters (ml) of volume of irrigation solution used for the surgical procedure.
次要结局
- Posterior Capsule Opacificaiton(1-Week Postoperative)
- Corneal Edema 1 Day Postoperative(1 Day Postoperative)
- Corneal Edema 1-Week Postoperative(1-Week Postoperative)
- Posterior Capsule Opacification(1-Month Postoperative)
- BCDVA at 1 Week(1- week postoperative)
- Change in Corneal Thickness(Measured at Baseline, 1 Day, 1 Week and 1 Month postoperative.)
- Corneal Edema 1 Month Postoperative(1 Month Postoperative)
- BCDVA at 1 Month(1 month postoperative)
- Corneal Edema(Pre-operative)
- Periphery(1-Month Postoperative)
- Total Surgical Procedure Time(Assessed during the surgical procedure.)
- Anterior Chamber Flare(1-Month Postoperative)
- Other Slit-Lamp Findings(1-Month Postoperative)
- Vessels(1-Month Postoperative)
- UCVA at 1-Day(Postoperative 1 Day)
- Corneal Cells(1-Month Postoperative)
- Corneal Staining Erosion(1-Month Postoperative)
- Macula(1-Month Postoperative)
- Disc Appearance(1-Month Postoperative)