A Prospective, Multicenter Clinical Trial of the VisAbility™ Micro Insert System for the Improvement of Near Visual Acuity in Presbyopic Subjects - Long Term Follow-up
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Presbyopia
- Sponsor
- Refocus Group, Inc.
- Enrollment
- 287
- Locations
- 13
- Primary Endpoint
- Primary Safety Measure - Partial or Complete Explantation
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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 clinical trial. Study subjects will be examined at 36, 48, and 60 months post-operatively (based on the anniversary of their first VisAbility™ surgery) with no planned interventions.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects who were implanted with the VisAbility™ Micro Insert in Protocol VIS-2014
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Primary Safety Measure - Partial or Complete Explantation
Time Frame: From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.
Partial explantation (surgical removal of 1-3 Micro Inserts per eye), or complete explantation (surgical removal of all 4 Micro inserts per eye), and reason(s). Safety measure will be recorded if the event occurs.
Primary Safety Measure - Anterior Segment Ischemia
Time Frame: From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.
Anterior Segment Ischemia (decreased blood perfusion to the anterior segment of the eye (Grades 2 - 4--the higher the grade, the worse the outcome). Grade 2 is decreased pupil reactivity (\<25% of Percent Constriction using Neuroptics Pupillometry) Grade 3 is decreased pupil reactivity, plus anterior chamber reaction of Grade 2 cell and/or flare as assessed via biomicrosope examination Grade 4 is decreased pupil reactivity, plus anterior chamber reaction of Grade 2 cell and/or flare, plus corneal edema (Grade 3 with Striate Keratopathy) as assessed via biomicroscope examination Safety measure will be recorded if the event occurs.
Primary Safety Measure -Participants With Serious Ocular and Serious Non-Ocular Adverse Events
Time Frame: From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.
Rate of Individual Participants with Serious Ocular and Serious Non-Ocular Adverse Events (SAE's). Safety measure will be recorded if the event occurs.
Primary Safety Measure - Segment Exposure.
Time Frame: From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.
Segment exposure due to conjunctival and/or scleral erosion as assessed via biomicroscopic examination. Safety measure will be recorded if the event occurs.
Secondary Outcomes
- Secondary Safety Measure - Number of Participants With Adverse Events(From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.)
- Secondary Effectiveness Measure - Distance Corrected Near Visual Acuity--Effectiveness Cohort(From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.)
- Secondary Safety Measure - Best Corrected Distance Visual Acuity (BCDVA) in Eyes Examined at 36, 48 and 60 Month Visits(From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.)
- Secondary Safety Measure - Slit Lamp(From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.)
- Secondary Safety Measure - Fundus Exam(From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.)
- Secondary Safety Measure - Intraocular Pressure (IOP)(From date of enrollment until the date of study withdrawal or study completion, whichever came first, assessed up to 60 months post-surgery.)
- Secondary Effectiveness Measure--Uncorrected Near Visual Acuity-Effectivness Cohort(From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.)