A Multicenter Clinical Evaluation of the EVO/EVO+ Visian® Implantable Collamer® Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 327
- 试验地点
- 14
- 主要终点
- Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes.
研究概览
简要总结
This objective of this study is to evaluate the safety, and to collect supportive data on effectiveness of the EVO/EVO+ Visian® Implantable Collamer® Lens (ICL) in study participants who have a diagnosis of myopia or myopia with astigmatism. Primary study analysis will be evaluated when 300 primary eyes complete 6 months of follow-up. Final study analysis will be assessed when all treated eyes complete 36 months of follow-up.
详细描述
This study will be conducted at up to 20 clinical sites in the United States by surgeons qualified by training and experience to implant STAAR ICLs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to high myopia or myopic astigmatism correctable with available EVO/EVO+ ICL powers.
- •Stable refractive history within 0.50 D each cylinder and spherical equivalent (SE) for 1 year prior to implantation.
- •Able and willing to return for scheduled follow-up examinations after surgery.
- •Able to read, understand and provide written informed consent on the Institutional Review Board (IRB)-approved informed consent form (ICF) and provide authorization as appropriate for local privacy regulations.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Insulin-dependent diabetes or diabetic retinopathy.
- •History of previous ocular surgery.
- •Cataract of any grade.
- •Monocular.
- •Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study.
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
Primary Eyes
First implanted eyes of enrolled participants
干预措施: EVO/EVO+ Visian ICL (Device)
Fellow Eyes
Second implanted eyes of enrolled participants
干预措施: EVO/EVO+ Visian ICL (Device)
结局指标
主要结局
Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes.
时间窗: 6 months
Number of eyes with ECD \<1000 cells/mm² at month 6 in primary eyes.
Endothelial Cell Density (ECD) Change in Primary Eyes.
时间窗: 6 Months
Endothelial Cell Density (ECD) was determined by analysis of images captured by a specular microscopy device. These images were analyzed by a reading center to determine ECD values before surgery and 6 months after surgery to calculate the mean change (% decrease) of ECD from baseline at month 6 in primary eyes. Negative outcome values represent a reduction in Endothelial Cell Density.
Endothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes.
时间窗: 6 months
Number of eyes with ECD \<1500 cells/mm² at month 6 in primary eyes.
Number of Ocular Adverse Events (AEs) in Primary Eyes.
时间窗: 6 Months
Number of Primary Eyes Requiring Peripheral Iridotomy (PI)
时间窗: 6 Months
Incidence of PI required to treat elevated intraocular pressure (IOP) caused by mechanical pupillary block in primary eyes.
次要结局
- Endothelial Cell Density (ECD) <1000 Cell/mm² in Primary and Fellow Eyes.(6 months)
- Endothelial Cell Density (ECD) <1500 Cell/mm² in Primary and Fellow Eyes.(6 months)
- Number of Primary and Fellow Eyes Requiring Peripheral Iridotomy (PI)(6 Months)
- Number of Ocular Adverse Events (AEs) in Primary and Fellow Eyes(6 Months)
- Endothelial Cell Density (ECD) Change in Primary and Fellow Eyes.(6 Months)