A Limited Patient Cohort Follow-up Study to Assess the Long-term Safety and Performance of Hydrophobic and Hydrophilic Intraocular Lenses in Bilateral Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Slit Lamp Examination
研究概览
简要总结
Subjects who had a bilateral age-related cataract surgery with the IOLs AT ELANA 841P and AT LISA tri 839MP will be contacted and invited to attend a postoperative visit more than one year after the surgery
详细描述
The main objective of this clinical investigation is to collect data on the IOLs AT ELANA 841P and AT LISA tri 839MP in subjects who underwent bilateral cataract surgery with the use of the two different types of IOLs to confirm the long-term performance and safety of the IOLs.
Retro-prospective, comparative, non-interventional, non-randomized, single center study on medical devices with one follow-up visit after more than 12 months of a bilateral cataract surgery.Subjects who had a bilateral age-related cataract surgery with the IOLs AT ELANA 841P and AT LISA tri 839MP will be contacted and invited to attend a postoperative visit more than one year after the surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient of any gender;
- •Patients who had an uncomplicated (no intra-operative complication) age-related cataract surgery
- •Currently implanted with an IOL model AT ELANA 841P into the capsular bag in one eye and with the IOL model AT LISA tri 839MP into the capsular bag of the other eye.
- •The postoperative visit was scheduled to be conducted more than one year after the second eye surgery.
- •Given written informed consent by patient.
排除标准
- •Patients unable to meet the limitations of the protocol or likely of non-cooperation during the study
- •Patient whose freedom is impaired by administrative or legal order
- •Concurrent participation in another drug or device investigation that could confound the outcome of this investigation.
结局指标
主要结局
Slit Lamp Examination
时间窗: 12 to 24 months after cataract surgery
Monocular Corrected Distance Visual Acuity (CDVA)
时间窗: 12 to 24 months after cataract surgery
次要结局
未报告次要终点