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

Presbyopia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03811249
• Other study ID #: VIS-2014-5YR
• Status: Completed
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: October 29, 2021

Study information

• Verified date: November 2023
• Source: Refocus Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: October 29, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 60 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Presbyopia

Intervention

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.

Locations

Country	Name	City	State
United States	Chu Vision Institute	Bloomington	Minnesota
United States	Key Whitman Eye Center	Dallas	Texas
United States	The Midwest Center for Sight	Des Plaines	Illinois
United States	Physicians Protocol	Greensboro	North Carolina
United States	Aloha Laser Vision	Honolulu	Hawaii
United States	Eye Surgeons Of Indiana PC	Indianapolis	Indiana
United States	Eye Care Institute	Louisville	Kentucky
United States	Coastal Vision	Orange	California
United States	Braverman-Terry-Oei-Eye Associates	San Antonio	Texas
United States	Gordon Schanzlin New Vision Institute	San Diego	California
United States	South Shore Eye Care LLP	Wantagh	New York
United States	Comprehensive EyeCare of Central Ohio	Westerville	Ohio
United States	Bucci Laser Vision	Wilkes-Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Refocus Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	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	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	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	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	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	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	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	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.

External Links

•   Sponsor Website