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

NCT03811249 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 287

Last updated 2023-11-18

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Refocus Group, Inc.

    lead INDUSTRY

Principal Investigators

  • David Schanzlin, Dr · Chief Medical Officer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-03
Primary Completion
2021-10-01
Completion
2021-10-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03811249 on ClinicalTrials.gov