Post Marketing Clinical Evaluation Assessing the Visual Performance of Hanita Lenses "Intensity SL" Intraocular Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The aim of this study is to evaluate performance of Hanita Lenses Intensity SL IOL.
研究概览
简要总结
This clinical study will assess the safety and performance of Intensity SL IOL, 1 year post operation.
The study will also evaluate the patient satisfaction of the implanted patients.
详细描述
Study Design:
This study is an ambispective, single arm single center, open label study.
Study Objectives:
The aim of this study is to evaluate performance of Hanita Lenses Intensity SL IOL. The primary aim of this study is to evaluate the binocular defocus Curve and visual acuity for far, intermediate and near distance after Intensity SL IOL implantation.
The second aim of this study is to evaluate the patient satisfaction 12 to 24 months post-operation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Implanted bilaterally using Hanita Intensity SL IOL
- •12 to 24 months post implantation
- •Signed informed consent
排除标准
- •Patients with any other pre-implantation and post implantation eye disease or condition that might affect the safety and efficacy evaluation.
结局指标
主要结局
The aim of this study is to evaluate performance of Hanita Lenses Intensity SL IOL.
时间窗: 21-24 months post operation
Performance of the IOL will be evaluated by assessing the defocus Curve and visual acuity for far, intermediate and near distance after Intensity SL IOL implantation.
次要结局
- The second aim of this study is to evaluate the patient satisfaction post-operation.(21-24 months post operation)