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A Clinical Trial of The VisAbility Micro Insert System for Presbyopic Patients

NCT02374671 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 365

Last updated 2020-01-06

Study results available
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Summary

The purpose of this study is to evaluate the safety and effectiveness of the VisAbility Micro Insert System for the improvement of near visual acuity in presbyopic patients.

Conditions

Interventions

DEVICE

VisAbility Micro Insert

Subjects are implanted with the VisAbility Micro Insert (Model SGP-046) and followed for 24 months.

Sponsors & Collaborators

  • Refocus Group, Inc.

    lead INDUSTRY

Principal Investigators

  • Selene Burke, O.D. · V.P. Clinical Affairs

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-15
Primary Completion
2018-04-13
Completion
2018-04-13

Countries

  • United States

Study Locations

More Related Trials

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 NCT02374671 on ClinicalTrials.gov