Status:
COMPLETED
Long Term Follow-up of the VisAbility™ Micro Insert System for Presbyopic Patients
Lead Sponsor:
Refocus Group, Inc.
Conditions:
Presbyopia
Eligibility:
All Genders
45-60 years
Phase:
NA
Brief Summary
The objective of this study is to obtain an additional 36 months of safety and effectiveness data from all subjects who were implanted with the VisAbility™ Micro Insert in the VIS-2014 clinical trial.
Detailed Description
VIS-2014-5YR is a multicenter, observational study to evaluate the long-term safety of the VisAbility™ Micro Inserts in subjects who were implanted with the VisAbility™ Micro Insert in the VIS-2014 cl...
Eligibility Criteria
Inclusion
- Subjects who were implanted with the VisAbility™ Micro Insert in Protocol VIS-2014
Exclusion
- N/A
Key Trial Info
Start Date :
December 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2021
Estimated Enrollment :
287 Patients enrolled
Trial Details
Trial ID
NCT03811249
Start Date
December 3 2018
End Date
October 29 2021
Last Update
November 18 2023
Active Locations (13)
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1
Coastal Vision
Orange, California, United States, 92868
2
Gordon Schanzlin New Vision Institute
San Diego, California, United States, 92122
3
Aloha Laser Vision
Honolulu, Hawaii, United States, 96814
4
The Midwest Center for Sight
Des Plaines, Illinois, United States, 60016