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

NCT03811249 | Completed Results DMC FDA Device

• 1 other identifier: VIS-2014-5YR
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 13

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.

Conditions

Presbyopia

Keywords

Near Vision; Reading Vision; Reading Glasses; Reading; Readers; Presbyopic

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Secondary Safety Measure - Best Corrected Distance Visual Acuity (BCDVA) in Eyes Examined at 36, 48 and 60 Month Visits

  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)

  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

  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

  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

  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.

Study Arms (1)

Implantation-Non-randomized

EXPERIMENTAL

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

Interventions

VisAbility™ Micro Insert DEVICE

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.

Implantation-Non-randomized

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Refocus Group, Inc.: lead

Study Sites (13)

Coastal Vision

Orange, California, 92868, United States

Location

Gordon Schanzlin New Vision Institute

San Diego, California, 92122, United States

Location

Aloha Laser Vision

Honolulu, Hawaii, 96814, United States

Location

The Midwest Center for Sight

Des Plaines, Illinois, 60016, United States

Location

Eye Surgeons Of Indiana PC

Indianapolis, Indiana, 46260, United States

Location

Eye Care Institute

Louisville, Kentucky, 40206, United States

Location

Chu Vision Institute

Bloomington, Minnesota, 55420, United States

Location

South Shore Eye Care LLP

Wantagh, New York, 11793, United States

Location

Physicians Protocol

Greensboro, North Carolina, 27401, United States

Location

Comprehensive EyeCare of Central Ohio

Westerville, Ohio, 43082, United States

Location

Bucci Laser Vision

Wilkes-Barre, Pennsylvania, 18702, United States

Location

Key Whitman Eye Center

Dallas, Texas, 75242, United States

Location

Braverman-Terry-Oei-Eye Associates

San Antonio, Texas, 78212, United States

Location

Related Links

• Sponsor Website

MeSH Terms

Conditions

Presbyopia; Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Limitations and Caveats

Delay in VIS-2014-5YR approval and initiation resulted in some of the participants falling outside the 36 month window at the time of study commencement. COVID shutdowns affected study accountability.

Results Point of Contact

• Title: Linda Stewart, Director of Regulatory and Quality
• Organization: Refocus Group, Inc.

lstewart@refocus-group.com

214-368-0200

Study Officials

• David Schanzlin, Dr

  Chief Medical Officer

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: January 22, 2019
• Study Start: December 3, 2018
• Primary Completion: October 1, 2021
• Study Completion: October 29, 2021
• Last Updated: November 18, 2023
• Results First Posted: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)