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

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ClinicalTrials.gov Identifier: NCT03811249
Recruitment Status : Enrolling by invitation
First Posted : January 21, 2019
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Presbyopia Device: VisAbility™ Micro Insert Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A non-randomized single group design. All subjects who were implanted with the VisAbility™ Micro Insert (360 subjects) will be invited to participate. Actual sample size will be determined at the completion of enrollment.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

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.




Primary Outcome Measures :
  1. Primary safety measure - Partial explantation [ 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. ]
    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.

  2. Primary safety measure - Anterior Segment Ischemia [ 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. ]
    Anterior Segment Ischemia (Grades 2 - 4). Safety measure will be recorded if the event occurs.

  3. Primary safety measure - Segment exposure. [ 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. ]
    Segment exposure due to conjunctival and/or scleral erosion. Safety measure will be recorded if the event occurs.

  4. Primary safety measure - Serious Adverse Events [ 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. ]
    Rate of Serious Adverse Events (SAE's). Safety measure will be recorded if the event occurs.


Secondary Outcome Measures :
  1. Secondary safety measure - Best Corrected Distance Visual Acuity (BCDVA) [ 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. ]
    Best Corrected Distance Visual Acuity (BCDVA) will be measured and recorded.

  2. Secondary safety measure - Intraocular Pressure (IOP) [ 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. ]
    IOP increase > 10 mm Hg over baseline or IOP > 30 mm Hg

  3. Secondary safety measure - Slit Lamp [ 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. ]
    Slit Lamp findings

  4. Secondary safety measure - Fundus Exam [ 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. ]
    Fundus exam findings

  5. Secondary safety measure - Adverse Events [ 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. ]
    Rate of Adverse Events (AE's)

  6. Secondary effectiveness measure - Uncorrected and Distance Corrected Near Visual Acuity [ 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. ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   47 Years to 62 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811249


Locations
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United States, California
Coastal Vision
Orange, California, United States, 92868
Gordon Schanzlin New Vision Institute
San Diego, California, United States, 92122
United States, Hawaii
Aloha Laser Vision
Honolulu, Hawaii, United States, 96814
United States, Illinois
The Midwest Center for Sight
Des Plaines, Illinois, United States, 60016
United States, Indiana
Eye Surgeons Of Indiana PC
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Eye Care Institute
Louisville, Kentucky, United States, 40206
United States, Minnesota
Chu Vision Institute
Bloomington, Minnesota, United States, 55420
United States, New York
South Shore Eye Care LLP
Wantagh, New York, United States, 11793
United States, North Carolina
Physicians Protocol
Greensboro, North Carolina, United States, 27401
United States, Ohio
Comprehensive EyeCare of Central Ohio
Westerville, Ohio, United States, 43082
United States, Pennsylvania
Bucci Laser Vision
Wilkes-Barre, Pennsylvania, United States, 18702
United States, Texas
Key Whitman Eye Center
Dallas, Texas, United States, 75242
Braverman-Terry-Oei-Eye Associates
San Antonio, Texas, United States, 78212
Sponsors and Collaborators
Refocus Group, Inc.
Investigators
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Principal Investigator: David Schanzlin, Dr Chief Medical Officer

Additional Information:
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Responsible Party: Refocus Group, Inc.
ClinicalTrials.gov Identifier: NCT03811249     History of Changes
Other Study ID Numbers: VIS-2014-5YR
First Posted: January 21, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Keywords provided by Refocus Group, Inc.:
Near Vision
Reading Vision
Reading Glasses
Reading
Readers
Presbyopic
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases