Post-Market Clinical Investigation of the Clareon® IOL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 20
- 主要终点
- Percentage of First Implanted Eyes Achieving Best-Corrected Distance Visual Acuity (BCDVA) of 0.3 Logarithm Minimum Angle of Resolution (logMAR) or Better at 1 Year Post-Implantation
研究概览
简要总结
The primary purpose of this study is to evaluate the long-term (3 years) visual acuity and adverse event outcomes for the Clareon® Intraocular Lens (IOL). A comparison to historical safety and performance endpoint (SPE) rates as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014 will be conducted at one year. The secondary purpose of this study is to evaluate the visual acuity outcomes with the Clareon IOL at Years 2 and 3.
详细描述
Subjects will attend a total of 12 study visits over a period of approximately 36 months: One preoperative screening visit, two operative visits, and nine post-implantation visits. Both eyes will be implanted, with the second eye implantation to occur 2-21 days after the first. Primary endpoint data will be collected at the Year 1 visit (Day 330-420 post-implantation from second eye 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
- •Diagnosed with bilateral cataracts
- •Planned small incision cataract removal surgery
- •Able to comprehend and willing to sign a statement of informed consent and complete all required post-implantation visits
排除标准
- •Subjects who may reasonably be expected to require ocular surgical treatment or refractive surgical procedures at any time during the study
- •Certain eye conditions, as specified in the protocol, including but not limited to glaucoma, diabetic retinopathy, diabetic macular edema, and macular degeneration
- •Pregnant or lactating, current or planned during the course of the study
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Percentage of First Implanted Eyes Achieving Best-Corrected Distance Visual Acuity (BCDVA) of 0.3 Logarithm Minimum Angle of Resolution (logMAR) or Better at 1 Year Post-Implantation
时间窗: Year 1 post-implantation from second eye surgery
Visual acuity (VA) was tested for the first implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. VA was compared to the historical safety and performance endpoint (SPE) of 92.5% \[as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014\].
Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 1 Year Post-Implantation
时间窗: Year 1 post-implantation from second eye surgery
VA was tested for the second implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. VA was compared to the historical SPE of 92.5% (EN ISO 11979-7:2014).
次要结局
- UCDVA at 2 Years Post-Implantation - First Implanted Eye(Year 2 post-implantation from second eye surgery)
- Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation(Year 2 post-implantation from second eye surgery)
- Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation(Year 2 post-implantation from second eye surgery)
- Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation(Year 3 post-implantation from second eye surgery)
- Uncorrected Distance Visual Acuity (UCDVA) at 1 Year Post-Implantation - First Implanted Eye(Year 1 post-implantation from second eye surgery)
- UCDVA at 2 Years Post-Implantation - Second Implanted Eye(Year 2 post-implantation from second eye surgery)
- Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation(Year 3 post-implantation from second eye surgery)
- UCDVA at 1 Year Post-Implantation - Second Implanted Eye(Year 1 post-implantation from second eye surgery)
- UCDVA at 3 Years Post-Implantation - First Implanted Eye(Year 3 post-implantation from second eye surgery)
- UCDVA at 3 Years Post-Implantation - Second Implanted Eye(Year 3 post-implantation from second eye surgery)