Clinical trial NCT03811249: 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
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Keywords: Near Vision
Reading Vision
Reading Glasses
Reading
Readers
Presbyopic
Lead sponsor: Refocus Group, Inc.
Sponsor class: INDUSTRY
First posted: 2019-01-22
Enrollment: 287
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Primary Safety Measure - Partial or Complete Explantation
timeFrame: 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.
measure: Primary Safety Measure - Anterior Segment Ischemia
timeFrame: 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.
measure: Primary Safety Measure - Segment Exposure.
timeFrame: 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.
measure: Primary Safety Measure -Participants With Serious Ocular and Serious Non-Ocular Adverse Events
timeFrame: 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:
measure: Secondary Safety Measure - Best Corrected Distance Visual Acuity (BCDVA) in Eyes Examined at 36, 48 and 60 Month Visits
timeFrame: From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.
measure: Secondary Safety Measure - Intraocular Pressure (IOP)
timeFrame: From date of enrollment until the date of study withdrawal or study completion, whichever came first, assessed up to 60 months post-surgery.
measure: Secondary Safety Measure - Slit Lamp
timeFrame: 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.
measure: Secondary Safety Measure - Fundus Exam
timeFrame: 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.
measure: Secondary Safety Measure - Number of Participants With Adverse Events
timeFrame: 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.
measure: Secondary Effectiveness Measure - Distance Corrected Near Visual Acuity--Effectiveness Cohort
timeFrame: 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.
measure: Secondary Effectiveness Measure--Uncorrected Near Visual Acuity-Effectivness Cohort
timeFrame: 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.
Other outcomes:
Locations:
city: Orange
country: United States
facility: Coastal Vision
state: California
city: San Diego
country: United States
facility: Gordon Schanzlin New Vision Institute
state: California
city: Honolulu
country: United States
facility: Aloha Laser Vision
state: Hawaii
city: Des Plaines
country: United States
facility: The Midwest Center for Sight
state: Illinois
city: Indianapolis
country: United States
facility: Eye Surgeons Of Indiana PC
state: Indiana
city: Louisville
country: United States
facility: Eye Care Institute
state: Kentucky
city: Bloomington
country: United States
facility: Chu Vision Institute
state: Minnesota
city: Wantagh
country: United States
facility: South Shore Eye Care LLP
state: New York
city: Greensboro
country: United States
facility: Physicians Protocol
state: North Carolina
city: Westerville
country: United States
facility: Comprehensive EyeCare of Central Ohio
state: Ohio
city: Wilkes-Barre
country: United States
facility: Bucci Laser Vision
state: Pennsylvania
city: Dallas
country: United States
facility: Key Whitman Eye Center
state: Texas
city: San Antonio
country: United States
facility: Braverman-Terry-Oei-Eye Associates
state: Texas
Study officials:
affiliation: Chief Medical Officer
name: David Schanzlin, Dr
role: PRINCIPAL_INVESTIGATOR
References: