Long Term Follow-up of the VisAbility™ Micro Insert System for Presbyopic Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Device: 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.
|
Outcome Measures
Primary Outcome Measures
- Primary safety measure - Partial explantation [From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.]
Partial explantation (1-3 Micro inserts per eye) or complete explantation (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 enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.]
Anterior Segment Ischemia (Grades 2 - 4). Safety measure will be recorded if the event occurs.
- Primary safety measure - Segment exposure. [From date of 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. Safety measure will be recorded if the event occurs.
- Primary safety measure - Serious Adverse Events [From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.]
Rate of Serious Adverse Events (SAE's). Safety measure will be recorded if the event occurs.
Secondary Outcome Measures
- Secondary safety measure - Best Corrected Distance Visual Acuity (BCDVA) [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) will be measured and recorded.
- 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
- Secondary safety measure - Slit Lamp [From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.]
Slit Lamp findings
- Secondary safety measure - Fundus Exam [From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.]
Fundus exam findings
- Secondary safety measure - Adverse Events [From date of 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)
- Secondary effectiveness measure - Uncorrected and Distance Corrected Near Visual Acuity [From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.]
Change in uncorrected and distance corrected near visual acuity and letters correct in the primary eye of bilaterally implanted subjects (with all eight implants in place), as compared to baseline (VIS-2014).
Eligibility Criteria
Criteria
Inclusion Criteria:
- Subjects who were implanted with the VisAbility™ Micro Insert in Protocol VIS-2014
Exclusion Criteria:
- N/A
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 |
| 5 | Eye Surgeons Of Indiana PC | Indianapolis | Indiana | United States | 46260 |
| 6 | Eye Care Institute | Louisville | Kentucky | United States | 40206 |
| 7 | Chu Vision Institute | Bloomington | Minnesota | United States | 55420 |
| 8 | South Shore Eye Care LLP | Wantagh | New York | United States | 11793 |
| 9 | Physicians Protocol | Greensboro | North Carolina | United States | 27401 |
| 10 | Comprehensive EyeCare of Central Ohio | Westerville | Ohio | United States | 43082 |
| 11 | Bucci Laser Vision | Wilkes-Barre | Pennsylvania | United States | 18702 |
| 12 | Key Whitman Eye Center | Dallas | Texas | United States | 75242 |
| 13 | Braverman-Terry-Oei-Eye Associates | San Antonio | Texas | United States | 78212 |
Sponsors and Collaborators
- Refocus Group, Inc.
Investigators
- Principal Investigator: David Schanzlin, Dr, Chief Medical Officer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- VIS-2014-5YR