Long Term Follow-up of the VisAbility™ Micro Insert System for Presbyopic Patients

Not Applicable

Completed

Conditions: Presbyopia

Interventions: Device: VisAbility™ Micro Insert

Registration Number: NCT03811249

Lead Sponsor: Refocus Group, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 287

Inclusion Criteria

Subjects who were implanted with the VisAbility™ Micro Insert in Protocol VIS-2014

Exclusion Criteria

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Implantation-Non-randomized	VisAbility™ Micro Insert	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.

Primary Outcome Measures

Name	Time	Method
Primary Safety Measure - Partial or Complete Explantation	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	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	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.	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 Outcome Measures

Name	Time	Method
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.	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
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.	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).
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.	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.
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.	Slit Lamp findings in all eyes implanted or explanted during the VIS-2014 clinical study and subsequently enrolled in the VIS-2014-5YR
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.	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
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.	IOP increase \> 10 mm Hg over baseline or IOP \> 30 mm Hg as measured via Goldmann applanation tonometry
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.	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).

Trial Locations

Locations (13): South Shore Eye Care LLP
🇺🇸
Wantagh, New York, United States
Gordon Schanzlin New Vision Institute
🇺🇸
San Diego, California, United States
Physicians Protocol
🇺🇸
Greensboro, North Carolina, United States
Bucci Laser Vision
🇺🇸
Wilkes-Barre, Pennsylvania, United States
Key Whitman Eye Center
🇺🇸
Dallas, Texas, United States
Coastal Vision
🇺🇸
Orange, California, United States
The Midwest Center for Sight
🇺🇸
Des Plaines, Illinois, United States
Aloha Laser Vision
🇺🇸
Honolulu, Hawaii, 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
Comprehensive EyeCare of Central Ohio
🇺🇸
Westerville, Ohio, United States
Braverman-Terry-Oei-Eye Associates
🇺🇸
San Antonio, Texas, United States