A Continuation Study To Monitor The Long Term Safety Of Patients Completing Protocols ACU-P08-020/020A
NCT ID: NCT01895088
Last Updated: 2017-08-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
271 participants
INTERVENTIONAL
2011-05-31
2015-08-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients prev. impl. with ACI 7000 PDT
AcuFocus Corneal Inlay ACI 7000 PDT
AcuFocus Corneal Inlay ACI 7000 PDT
Inlay implanted in cornea for improvement of near vision
Interventions
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AcuFocus Corneal Inlay ACI 7000 PDT
Inlay implanted in cornea for improvement of near vision
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
45 Years
60 Years
ALL
Yes
Sponsors
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AcuFocus, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Durrie, M.D.
Role: PRINCIPAL_INVESTIGATOR
Durrie Vision
Chad Betts, M.D., R.Ph
Role: PRINCIPAL_INVESTIGATOR
MacDonald Eye Associates
Vance Thompson, M.D.
Role: PRINCIPAL_INVESTIGATOR
Vance Thompson Vision
Jay Pepose, M.D.
Role: PRINCIPAL_INVESTIGATOR
Pepose Vision Institute
Kevin Waltz, M.D.
Role: PRINCIPAL_INVESTIGATOR
Eye Surgeons of Indiana
John Vukich, M.D.
Role: PRINCIPAL_INVESTIGATOR
Davis Duehr Dean
Peter Hersh, M.D.
Role: PRINCIPAL_INVESTIGATOR
Cornea and Laser Eye Institute
Thomas Tooma, M.D.
Role: PRINCIPAL_INVESTIGATOR
NVision
Colman Kraff, M.D.
Role: PRINCIPAL_INVESTIGATOR
Kraff Eye Institute
Robert Maloney, M.D.
Role: PRINCIPAL_INVESTIGATOR
Maloney Vision Institute
Scott MacRae, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Rochester Eye Institute - Strong Vision
Gary Foster, M.D.
Role: PRINCIPAL_INVESTIGATOR
Eye Center of Northern Colorado
Phillip Hoopes, Sr., M.D.
Role: PRINCIPAL_INVESTIGATOR
Hoopes Vision
Locations
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McDonald Eye Associates
Fayetteville, Arkansas, United States
Maloney Vision
Los Angeles, California, United States
NVision
Newport Beach, California, United States
Eye Center NOCO
Fort Collins, Colorado, United States
Kraff Eye Institute
Chicago, Illinois, United States
Eye Surgeons of Indiana
Indianapolis, Indiana, United States
Durrie Vision
Overland Park, Kansas, United States
Pepose Vision Institute
Chesterfield, Missouri, United States
The Cornea & Laser Eye Institute, P.A
Teaneck, New Jersey, United States
University of Rochester Eye Institute - Strong Vision
Rochester, New York, United States
Vance Thompson Vision
Sioux Falls, South Dakota, United States
Hoopes Vision
Sandy City, Utah, United States
Davis Duehr Dean
Madison, Wisconsin, United States
Countries
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Related Links
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Sponsor website
Other Identifiers
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ACU-P12-020C
Identifier Type: -
Identifier Source: org_study_id
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