search
Back to results

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

Primary Purpose

Presbyopia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VisAbility™ Micro Insert
Sponsored by
Refocus Group, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia focused on measuring Near Vision, Reading Vision, Reading Glasses, Reading, Readers, Presbyopic

Eligibility Criteria

47 Years - 62 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Sites / Locations

  • Coastal Vision
  • Gordon Schanzlin New Vision Institute
  • Aloha Laser Vision
  • The Midwest Center for Sight
  • Eye Surgeons Of Indiana PC
  • Eye Care Institute
  • Chu Vision Institute
  • South Shore Eye Care LLP
  • Physicians Protocol
  • Comprehensive EyeCare of Central Ohio
  • Bucci Laser Vision
  • Key Whitman Eye Center
  • Braverman-Terry-Oei-Eye Associates

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implantation-Non-randomized

Arm Description

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.

Outcomes

Primary Outcome Measures

Primary safety measure - Partial explantation
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
Anterior Segment Ischemia (Grades 2 - 4). Safety measure will be recorded if the event occurs.
Primary safety measure - Segment exposure.
Segment exposure due to conjunctival and/or scleral erosion. Safety measure will be recorded if the event occurs.
Primary safety measure - Serious Adverse Events
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)
Best Corrected Distance Visual Acuity (BCDVA) will be measured and recorded.
Secondary safety measure - Intraocular Pressure (IOP)
IOP increase > 10 mm Hg over baseline or IOP > 30 mm Hg
Secondary safety measure - Slit Lamp
Slit Lamp findings
Secondary safety measure - Fundus Exam
Fundus exam findings
Secondary safety measure - Adverse Events
Rate of Adverse Events (AE's)
Secondary effectiveness measure - Uncorrected and Distance Corrected Near Visual Acuity
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).

Full Information

First Posted
January 17, 2019
Last Updated
October 15, 2019
Sponsor
Refocus Group, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03811249
Brief Title
Long Term Follow-up of the VisAbility™ Micro Insert System for Presbyopic Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Refocus Group, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
Keywords
Near Vision, Reading Vision, Reading Glasses, Reading, Readers, Presbyopic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Implantation-Non-randomized
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
VisAbility™ Micro Insert
Intervention Description
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 Measure Information:
Title
Primary safety measure - Partial explantation
Description
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.
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.
Title
Primary safety measure - Anterior Segment Ischemia
Description
Anterior Segment Ischemia (Grades 2 - 4). Safety measure will be recorded if the event occurs.
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.
Title
Primary safety measure - Segment exposure.
Description
Segment exposure due to conjunctival and/or scleral erosion. Safety measure will be recorded if the event occurs.
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.
Title
Primary safety measure - Serious Adverse Events
Description
Rate of Serious Adverse Events (SAE's). Safety measure will be recorded if the event occurs.
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 Outcome Measure Information:
Title
Secondary safety measure - Best Corrected Distance Visual Acuity (BCDVA)
Description
Best Corrected Distance Visual Acuity (BCDVA) 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.
Title
Secondary safety measure - Intraocular Pressure (IOP)
Description
IOP increase > 10 mm Hg over baseline or IOP > 30 mm Hg
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.
Title
Secondary safety measure - Slit Lamp
Description
Slit Lamp findings
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.
Title
Secondary safety measure - Fundus Exam
Description
Fundus exam findings
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.
Title
Secondary safety measure - Adverse Events
Description
Rate of Adverse Events (AE's)
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.
Title
Secondary effectiveness measure - Uncorrected and Distance Corrected Near Visual Acuity
Description
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).
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
47 Years
Maximum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who were implanted with the VisAbility™ Micro Insert in Protocol VIS-2014 Exclusion Criteria: N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Schanzlin, Dr
Organizational Affiliation
Chief Medical Officer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coastal Vision
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Gordon Schanzlin New Vision Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States
Facility Name
Aloha Laser Vision
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
The Midwest Center for Sight
City
Des Plaines
State/Province
Illinois
ZIP/Postal Code
60016
Country
United States
Facility Name
Eye Surgeons Of Indiana PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Eye Care Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Chu Vision Institute
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55420
Country
United States
Facility Name
South Shore Eye Care LLP
City
Wantagh
State/Province
New York
ZIP/Postal Code
11793
Country
United States
Facility Name
Physicians Protocol
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Comprehensive EyeCare of Central Ohio
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43082
Country
United States
Facility Name
Bucci Laser Vision
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18702
Country
United States
Facility Name
Key Whitman Eye Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75242
Country
United States
Facility Name
Braverman-Terry-Oei-Eye Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.refocus-group.com
Description
Sponsor Website

Learn more about this trial

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

We'll reach out to this number within 24 hrs