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

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

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
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.

Study Design

• 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

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 :

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).

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: David Schanzlin, Dr; Chief Medical Officer

More Information

Additional Information:

Sponsor Website 

• Responsible Party: Refocus Group, Inc.
• ClinicalTrials.gov Identifier: NCT03811249 History of Changes
• Other Study ID Numbers: VIS-2014-5YR
• First Posted: January 21, 2019
• Last Update Posted: October 18, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Presbyopia; Refractive Errors; Eye Diseases