A Continuation Study To Monitor The Long Term Safety Of Patients Completing Protocols ACU-P08-020/020A
A Continuation Study To Monitor The Long Term Safety Of The AcuFocus ™ ACI 7000PDT Patients Completing Protocols ACU-P08-020/020A
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Arkansas
-
Fayetteville、Arkansas、美国、72703
- McDonald Eye Associates
-
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California
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Los Angeles、California、美国、90024
- Maloney Vision
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Newport Beach、California、美国、92660
- Nvision
-
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Colorado
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Fort Collins、Colorado、美国、80525
- Eye Center NOCO
-
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Illinois
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Chicago、Illinois、美国、60602
- Kraff Eye Institute
-
-
Indiana
-
Indianapolis、Indiana、美国、46256
- Eye Surgeons of Indiana
-
-
Kansas
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Overland Park、Kansas、美国、66211
- Durrie Vision
-
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Missouri
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Chesterfield、Missouri、美国、63017
- Pepose Vision Institute
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New Jersey
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Teaneck、New Jersey、美国、07666
- The Cornea & Laser Eye Institute, P.A
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New York
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Rochester、New York、美国、14618
- University of Rochester Eye Institute - Strong Vision
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South Dakota
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Sioux Falls、South Dakota、美国、57105
- Vance Thompson Vision
-
-
Utah
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Sandy City、Utah、美国、84070
- Hoopes Vision
-
-
Wisconsin
-
Madison、Wisconsin、美国、53715
- Davis Duehr Dean
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients who did not complete ACU-P08-020/020A.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Patients prev. impl. with ACI 7000 PDT
AcuFocus Corneal Inlay ACI 7000 PDT
|
Inlay implanted in cornea for improvement of near vision
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change (Increase) in Uncorrected Near Visual Acuity
大体时间：Baseline and 2 years
|
The change in the number of lines of threshold visual acuity achieved postoperatively.
|
Baseline and 2 years
|
合作者和调查者
调查人员
- 首席研究员：John Vukich, M.D.、Davis Duehr Dean
- 首席研究员：Daniel Durrie, M.D.、Durrie Vision
- 首席研究员：Chad Betts, M.D., R.Ph、MacDonald Eye Associates
- 首席研究员：Vance Thompson, M.D.、Vance Thompson Vision
- 首席研究员：Jay Pepose, M.D.、Pepose Vision Institute
- 首席研究员：Kevin Waltz, M.D.、Eye Surgeons of Indiana
- 首席研究员：Thomas Tooma, M.D.、Nvision
- 首席研究员：Colman Kraff, M.D.、Kraff Eye Institute
- 首席研究员：Robert Maloney, M.D.、Maloney Vision Institute
- 首席研究员：Scott MacRae, M.D.、University of Rochester Eye Institute - Strong Vision
- 首席研究员：Gary Foster, M.D.、Eye Center of Northern Colorado
- 首席研究员：Phillip Hoopes, Sr., M.D.、Hoopes Vision
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.