PresbyopiaNCT03811249

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

A study testing VisAbility™ Micro Insert in people with Presbyopia, run by VisDura, Inc. at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 45 to 60 years
Conditions the study is for: Presbyopia
What is being tested?: VisAbility™ Micro Insert
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 287 participants
Where: 13 sitesUnited States
Study dates: 3 Dec 2018to 29 Oct 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

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

Other trials in United States

About this study

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

Read the 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.

Conditions: Presbyopia
Being tested: VisAbility™ Micro Insert
Keywords: Near Vision, Reading Vision, Reading Glasses, Reading, Readers, Presbyopic
Medical subject headings: Presbyopia, Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VisAbility™ Micro InsertDevice
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.

Study groups in NCT03811249
Study group	Role	What they receive
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. Receives: Device: VisAbility™ Micro Insert

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Dec 201829 Oct 2021

First posted22 Jan 2019
Study start3 Dec 2018
Primary completion1 Oct 2021
Study completion29 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PresbyopiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
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)
Enrolment: 287 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03811249
Sponsor's protocol ID: VIS-2014-5YR
Status last verified: Nov 2023
First submitted: 17 Jan 2019
Last updated: 18 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia

All Presbyopia trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03811249
Acronym / sponsor ID: VIS-2014-5YR
Conditions: Presbyopia
Keywords: Near Vision, Reading Vision, Reading Glasses, Reading, Readers, Presbyopic
Study type: Interventional
Recruitment status: Completed
Enrolment: 287 participants (actual)
Lead sponsor: VisDura, Inc.Industry (pharma, biotech, devices)
Study start: 3 Dec 2018 (actual)
Primary completion: 1 Oct 2021 (actual)
Study completion: 29 Oct 2021 (actual)
First posted: 22 Jan 2019 (actual)
Results: Posted 18 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
Implantation-Non-randomized	Experimental	Device: VisAbility™ Micro InsertSubjects 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.

Who may qualify

Ages: 45 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VisAbility™ Micro InsertNo (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.	Device	Implantation-Non-randomized

Primary outcome

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

7 secondary outcomes

Secondary Safety Measure - Best Corrected Distance Visual Acuity (BCDVA) in Eyes Examined at 36, 48 and 60 Month Visits
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.
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.
Secondary Safety Measure - Slit Lamp
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.

Results and safety

Results posted to the registry on 18 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Implantation or Explantation Safety Cohort	287	219

Primary outcome: Primary Safety Measure - Partial or Complete Explantation

Time frame: 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.. Count of units. Unit: Eyes

Measure	Implantation or Explantation Safety Cohort n = 287
Partial Explant	2
Complete Explant	4

Population analysed: All implanted or explanted eyes in the VIS-2014 clinical study who were subsequently enrolled in the VIS-2014-5YR long term study

Primary outcome: Primary Safety Measure - Anterior Segment Ischemia

Time frame: 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.. Count of units. Unit: Eyes

Measure	Implantation or Explantation Safety Cohort n = 287
Value	0

Population analysed: All eyes that were previously implanted or explanted in the VIS-2014 clinical trial

Primary outcome: Primary Safety Measure - Segment Exposure.

Time frame: 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.. Count of units. Unit: Eyes

Measure	Implantation or Explantation Safety Cohort n = 287
Value	1

Population analysed: All eyes implanted or explanted in the VIS-2014 clinical study.

Primary outcome: Primary Safety Measure -Participants With Serious Ocular and Serious Non-Ocular Adverse Events

Time frame: 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.. Count of participants. Unit: Participants

Measure	Implantation or Explantation Safety Cohort n = 287
Participants with Ocular Serious Adverse Events	0
Participants with Non-Ocular Serious Adverse Events	4
Ischemic Stroke leading to Cortical Left Inferior Homonymous Hemianopsia	1
COVID-19 Infection	1
Hepatic Encephalopathy	1
Sepsis of Left Lower Leg leading to BKA and Coma	1

Population analysed: Subjects that were enrolled and implanted or explanted in the VIS-2014 clinical trial and subsequently enrolled in the VIS-2014-5YR long term study.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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 adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Implantation or Explantation Safety Cohort	4 of 287 (1.4%)	46 of 287 (16%)	0 of 287

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Sponsor WebsiteLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Presbyopia

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Schanzlin, Dr principal investigator

Chief Medical Officer

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing VisAbility™ Micro Insert in people with Presbyopia, run by VisDura, Inc. at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety Measure - Partial or Complete Explantation (time frame: 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03811249.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.