Long Term Follow-up of the VisAbility™ Micro Insert System for Presbyopic Patients
NCT ID: NCT03811249
Last Updated: 2023-11-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
287 participants
INTERVENTIONAL
2018-12-03
2021-10-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Implantation-Non-randomized
Subjects that previously participated in the VIS-2014 clinical trial that had VisAbility™ Micro Inserts surgically implanted in the eye(s) will be followed prospectively for an additional 36 month period to measure long term safety and effectiveness outcomes.
VisAbility™ Micro Insert
No (new) intervention will be administered during the course of this long term follow-up study. Subjects that previously participated in the VIS-2014 clinical trial that had VisAbility™ Micro Inserts surgically implanted in the eye(s) will be followed prospectively.
Interventions
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VisAbility™ Micro Insert
No (new) intervention will be administered during the course of this long term follow-up study. Subjects that previously participated in the VIS-2014 clinical trial that had VisAbility™ Micro Inserts surgically implanted in the eye(s) will be followed prospectively.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
45 Years
60 Years
ALL
No
Sponsors
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Refocus Group, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Schanzlin, Dr
Role: PRINCIPAL_INVESTIGATOR
Chief Medical Officer
Locations
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Coastal Vision
Orange, California, United States
Gordon Schanzlin New Vision Institute
San Diego, California, United States
Aloha Laser Vision
Honolulu, Hawaii, United States
The Midwest Center for Sight
Des Plaines, Illinois, United States
Eye Surgeons Of Indiana PC
Indianapolis, Indiana, United States
Eye Care Institute
Louisville, Kentucky, United States
Chu Vision Institute
Bloomington, Minnesota, United States
South Shore Eye Care LLP
Wantagh, New York, United States
Physicians Protocol
Greensboro, North Carolina, United States
Comprehensive EyeCare of Central Ohio
Westerville, Ohio, United States
Bucci Laser Vision
Wilkes-Barre, Pennsylvania, United States
Key Whitman Eye Center
Dallas, Texas, United States
Braverman-Terry-Oei-Eye Associates
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Sponsor Website
Other Identifiers
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VIS-2014-5YR
Identifier Type: -
Identifier Source: org_study_id
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