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

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

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.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: VisAbility™ Micro Insert

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 Type: Interventional
• Enrollment (Actual): 287
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 47 years to 62 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Measure - Partial or Complete Explantation	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.	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.
Primary Safety Measure - Anterior Segment Ischemia	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.	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.
Primary Safety Measure - Segment Exposure.	Segment exposure due to conjunctival and/or scleral erosion as assessed via biomicroscopic examination. Safety measure will be recorded if the event occurs.	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.
Primary Safety Measure -Participants With Serious Ocular and Serious Non-Ocular Adverse Events	Rate of Individual Participants with Serious Ocular and Serious Non-Ocular Adverse Events (SAE's). Safety measure will be recorded if the event occurs.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Safety Measure - Best Corrected Distance Visual Acuity (BCDVA) in Eyes Examined at 36, 48 and 60 Month Visits	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.	From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.
Secondary Safety Measure - Intraocular Pressure (IOP)	IOP increase > 10 mm Hg over baseline or IOP > 30 mm Hg as measured via Goldmann applanation tonometry	From date of enrollment until the date of study withdrawal or study completion, whichever came first, assessed up to 60 months post-surgery.
Secondary Safety Measure - Slit Lamp	Slit Lamp findings in all eyes implanted or explanted during the VIS-2014 clinical study and subsequently enrolled in the VIS-2014-5YR	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.
Secondary Safety Measure - Fundus Exam	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	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.
Secondary Safety Measure - Number of Participants With Adverse Events	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	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.
Secondary Effectiveness Measure - Distance Corrected Near Visual Acuity--Effectiveness Cohort	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).	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.
Secondary Effectiveness Measure--Uncorrected Near Visual Acuity-Effectivness Cohort	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).	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.

Collaborators and Investigators

• Sponsor: Refocus Group, Inc.
• Investigators: Principal Investigator: David Schanzlin, Dr, Chief Medical Officer

Publications and helpful links

Helpful Links

• Sponsor Website

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 29, 2021

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 22, 2019

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Near Vision; Reading Vision; Reading Glasses; Reading; Readers; Presbyopic
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: VIS-2014-5YR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes