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临床试验/NCT01895088
NCT01895088已完成不适用

A Continuation Study To Monitor The Long Term Safety Of The AcuFocus ™ ACI 7000PDT Patients Completing Protocols ACU-P08-020/020A

AcuFocus, Inc.26 个研究点 分布在 1 个国家目标入组 271 人开始时间: 2011年5月最近更新:
适应症
干预措施

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

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

Experimental

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

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (26)

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