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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
287
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.
Coastal Vision
Orange, California, United States
Gordon Schanzlin New Vision Institute
San Diego, California, United States
Aloha Laser Vision
Honolulu, Hawaii, United States
Primary Safety Measure - Partial or Complete Explantation
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.
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.
Primary Safety Measure - Anterior Segment Ischemia
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.
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.
Primary Safety Measure - Segment Exposure.
Segment exposure due to conjunctival and/or scleral erosion as assessed via biomicroscopic examination. Safety measure will be recorded if the event occurs.
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.
Primary Safety Measure -Participants With Serious Ocular and Serious Non-Ocular Adverse Events
Rate of Individual Participants with Serious Ocular and Serious Non-Ocular Adverse Events (SAE's). Safety measure will be recorded if the event occurs.
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.
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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
...and 3 more locations
Secondary Safety Measure - Best Corrected Distance Visual Acuity (BCDVA) in Eyes Examined at 36, 48 and 60 Month Visits
Best Corrected Distance Visual Acuity (BCDVA, which is distance visual acuity with the best distance refractive corretion in place) in all eyes seen at the 36 month postoperative visit, 48 month postoperative visit and 60 month postoperative visit will be measured and recorded.
Time frame: 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 - Intraocular Pressure (IOP)
IOP increase \> 10 mm Hg over baseline or IOP \> 30 mm Hg as measured via Goldmann applanation tonometry
Time frame: From date of enrollment until the date of study withdrawal or study completion, whichever came first, assessed up to 60 months post-surgery.
Secondary Safety Measure - Slit Lamp
Slit Lamp findings in all eyes implanted or explanted during the VIS-2014 clinical study and subsequently enrolled in the VIS-2014-5YR
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.
Secondary Safety Measure - Fundus Exam
Fundus exam findings (using binocular indirect ophthalmoscopy and/or the biomicroscope/slit lamp and a condensing lens) in all eyes implanted or explanted in the VIS-2014 clinical study and subsequently enrolled in the VIS-2014-5YR study
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.
Secondary Safety Measure - Number of Participants With Adverse Events
Rate of Adverse Events (AE's) in all participants implanted or explanted during the VIS-2014 clinical study and subsequently enrolled in the VIS-2014-5YR study
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.
Secondary Effectiveness Measure - Distance Corrected Near Visual Acuity--Effectiveness Cohort
distance corrected near visual acuity of 20/40 or better in the primary eye of bilaterally implanted subjects (with all eight implants in place), as compared to baseline (VIS-2014).
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.
Secondary Effectiveness Measure--Uncorrected Near Visual Acuity-Effectivness Cohort
uncorrected near visual acuity of 20/40 or better in the primary eye of bilaterally implanted subjects (with all eight implants in place), as compared to baseline (VIS-2014).
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.