A Continuation Study To Monitor The Long Term Safety Of The AcuFocus ™ ACI 7000PDT Patients Completing Protocols ACU-P08-020/020A
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 271
- 试验地点
- 26
- 主要终点
- Change (Increase) in Uncorrected Near Visual Acuity
研究概览
简要总结
This is a 2 year follow up study to monitor the long term safety of the ACI 7000PDT in subjects who are still implanted with the ACI and have successfully completed the ACU-P08-020/020A studies.
详细描述
This is a two year follow up study designed to monitor and obtain long-term safety data of the ACI 7000PDT in subjects who participated and successfully completed the ACU-P08-020/020A studies. Subjects must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form prior to participating. This continuation study follows subjects still implanted with the ACI and includes two visits, at 12-month intervals, after subjects have been exited (at Month 36) from the ACU-P08-020/020A studies. The first visit is at Month 48 following implantation followed by a final Month 60 visit. The study parameters being measured at these two visits include:
- Specular microscopy
- Slit lamp and fundus examination (ocular health)
- Corrected and uncorrected visual acuity
- Manifest mid-point refraction
- Corneal topography
- Dry eye assessment
- Mesopic and Photopic contrast sensitivity
- Adverse events and complications
All sites participating in the ACU-P08-020/020A studies were invited to participate in the continuation study.
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
- 45 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients must have completed participation in the ACU-P08-020/020A clinical trial.
- •Patients must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form.
排除标准
- •Patients who did not complete ACU-P08-020/020A.
研究组 & 干预措施
Patients prev. impl. with ACI 7000 PDT
AcuFocus Corneal Inlay ACI 7000 PDT
干预措施: AcuFocus Corneal Inlay ACI 7000 PDT (Device)
结局指标
主要结局
Change (Increase) in Uncorrected Near Visual Acuity
时间窗: Baseline and 2 years
The change in the number of lines of threshold visual acuity achieved postoperatively.
次要结局
未报告次要终点
