Trial of the PresView Implant for the Improvement of Near Vision in Presbyopic Patients
NCT ID: NCT01933750
Last Updated: 2016-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2013-02-28
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Randomized/Control
7 patients randomized to deferred treatment/control cohort at the 3 sub-study control sites = 21
No interventions assigned to this group
Non-Randomized/Treatment
Patients are non-randomized and if meet inclusion criteria receive the implantation of the PresVIEW device
PresVIEW Device Implantation
Interventions
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PresVIEW Device Implantation
Eligibility Criteria
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Inclusion Criteria
* Best Corrected Distance Visual Acuity of .80 (20/25) or better
* Patients must be alert, mentally competent, and able to comply with clinical study requirements
Exclusion Criteria
* Any chronic systemic diseases such as diabetes, heart disease, Lupus, etc.
* Any eye diseases such as eye inflammation, infection, cataract, or retinal diseases
45 Years
60 Years
ALL
Yes
Sponsors
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Refocus Ocular Europe, B.V.
INDUSTRY
Responsible Party
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Locations
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Midland Eye
Birmingham, , United Kingdom
Countries
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Other Identifiers
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EU-001
Identifier Type: -
Identifier Source: org_study_id
NCT01910207
Identifier Type: -
Identifier Source: nct_alias
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