Randomized Controlled Study of Fluid Accommodating IOL Outcomes Versus Monofocal Control
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 175
- 试验地点
- 11
- 主要终点
- Mean Photopic Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 meters)
研究概览
简要总结
The purpose of this clinical study is to evaluate the surgical, refractive, and visual outcomes with implantation of an investigational intraocular lens (IOL).
详细描述
In this study, eligible subjects will receive cataract surgery with IOL implantation in both eyes. IOL implantation in the second eye is intended to occur between 7 and 15 days after IOL implantation in the first eye. Subjects will be followed for 1 year after implantation.
This study will enroll 2 cohorts. Cohort 1 subjects will be randomized to receive either the test IOL (BAL-FAIOL) or the control IOL (Monofocal). Cohort 2 subjects will receive the test IOL only (BAL-FAIOL). Cohort 2 will follow Cohort 1.
This study will be conducted in Central America.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Cohort 1 is a subject and assessor-masked comparison. Cohort 2 does not utilize masking.
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
- •Able to understand and sign an Institutional Review Board / International Ethics Committee approved informed Consent form;
- •Willing and able to attend all scheduled study visits as required by the protocol;
- •Diagnosed with bilateral cataracts requiring removal by phacoemulsification with a clear corneal incision;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Subjects taking medications that may affect accommodation;
- •Clinically significant eye abnormalities as specified in the protocol;
- •Previous eye surgery as specified in the protocol;
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
Cohort 1: Monofocal
Monofocal IOL implanted in both eyes during cataract surgery (bilateral implantation)
干预措施: Monofocal IOL (Device)
Cohort 1: Monofocal
Monofocal IOL implanted in both eyes during cataract surgery (bilateral implantation)
干预措施: Cataract surgery (Procedure)
Cohort 2: BAL-FAIOL
BAL-FAIOL IOL implanted in both eyes during cataract surgery (bilateral implantation)
干预措施: BAL-FAIOL IOL (Device)
Cohort 2: BAL-FAIOL
BAL-FAIOL IOL implanted in both eyes during cataract surgery (bilateral implantation)
干预措施: Cataract surgery (Procedure)
Cohort 1: BAL-FAIOL
BAL-FAIOL IOL implanted in both eyes during cataract surgery (bilateral implantation)
干预措施: BAL-FAIOL IOL (Device)
Cohort 1: BAL-FAIOL
BAL-FAIOL IOL implanted in both eyes during cataract surgery (bilateral implantation)
干预措施: Cataract surgery (Procedure)
结局指标
主要结局
Mean Photopic Monocular Best Corrected Distance Visual Acuity (BCDVA) (4 meters)
时间窗: Month 6 post second eye implantation
Distance visual acuity will be measured with correction in place for each eye individually using letter charts and recorded in logarithm Minimum Angle of Resolution (logMAR). This outcome measure is pre-specified for Cohort 1 and Cohort 2.
Cumulative Adverse Events, including Secondary Surgical Interventions (SSIs)
时间窗: Up to Year 1
The number of adverse events, including SSI's, will be calculated from time of implantation. This outcome measure is pre-specified for Cohort 1 BAL-FAIOL IOL only.
Cumulative Adverse Events, including Secondary Surgical Interventions (SSIs) - Cohort 2
时间窗: Up to Year 1
The number of adverse events, including SSI's, will be calculated from time of implantation. The outcome measure is pre-specified for Cohort 2 only
次要结局
未报告次要终点