A Prospective, Multicenter, Open-label, Single-arm Clinical Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) IOL for Correction of Aphakia Following Cataract Extraction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 340
- 主要终点
- Proportion of Participants whose BCDVA Achieved 0.30 logMAR or Better at Form 5
研究概览
简要总结
A study to learn how well an artificial lens, called an intraocular lens (IOL), works in adults who have cataract surgery. During this type of surgery, the eye's natural lens is removed and replaced with an artificial lens to help restore vision.
The main goal of the study is to evaluate vision after the lens is placed in the eye. About one year after surgery, participants' vision will be measured to understand how clearly they can see.
The study will also look at how the lens performs over time, including how well it remains in place in the eye.
The results of this study will help provide more information about how this lens performs in adults undergoing cataract surgery.
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
- •Are able and willing to provide written informed consent, attend all scheduled visits, and comply with all trial procedures and follow-up
- •Have a study eye with visually significant cataract for which phacoemulsification cataract extraction and posterior chamber IOL implantation is indicated
- •Meet all other inclusion criteria outlined in the clinical study protocol
排除标准
- •Have serious systemic disease that could increase operative risk or conditions that can confound the surgical outcome
- •Within 30 days of the Screening Visit, use of systemic medications with significant ocular side effects or any medications that could confound the outcome or increase participant risk
- •Meet any other exclusion criteria outlined in the clinical study protocol
研究组 & 干预措施
KI-362-US1
Participants in this study receive an artificial lens (intraocular lens) implanted in the eye to replace the eye's natural lens that has been removed due to cataract surgery. The lens is delivered using a single-use, preloaded device that helps the surgeon place the lens safely and precisely into the natural lens capsule of the eye.
干预措施: KI-362-US1 (YP2.2VM) (Device)
结局指标
主要结局
Proportion of Participants whose BCDVA Achieved 0.30 logMAR or Better at Form 5
时间窗: Baseline (Form 0) through Visit 5 (Form 5), approximately Days 330-390
A binary outcome of achieving best-corrected distance visual acuity (BCDVA) of 0.30 logarithm of the minimum angle of resolution (logMAR) or better, or not, at postoperative days 330-390 (Form 5) BCDVA will be measured using Early Treatment Diabetic Retinopathy Study (ETDRS) illuminated charts
Proportion of Participants with Incidence of Selected Ocular Adverse Events
时间窗: Baseline through end of study (up to 15 months)
This safety outcome measure evaluates whether participants experience any of the following ocular adverse events after treatment, recorded as a binary outcome (occurrence: yes/no). Cumulative adverse events assessed include Cystoid macular edema, Hypopyon, Endophthalmitis, lens dislocation from the posterior chamber, Pupillary block, Retinal detachment, and secondary surgical interventions (excluding posterior capsulotomies). In addition, persistent adverse events are assessed as present or absent, including corneal stroma edema, persistent Cystoid macular edema, Iritis, and elevated intraocular pressure requiring treatment.
次要结局
- Proportion of Participants with Lens Axis Misalignment of <10 degrees From Baseline to Form 4(Baseline (Form 0) through Visit 4 (Form 4), approximately Days 120-180)
- Proportion of Participants with Lens Axis Misalignment of <10 degrees From Baseline to Form 5(Baseline (Form 0) through Visit 5 (Form 5), approximately Days 330-390)
- Proportion of Participants with Lens Axis Misalignment of <20 degrees From Baseline to Form 4(Baseline (Form 0) through Visit 4 (Form 4), approximately Days 120-180)
- Proportion of Participants with Lens Axis Misalignment of <20 degrees From Baseline to Form 5(Baseline (Form 0) through Visit 5 (Form 5), approximately Days 330-390)