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A Continuation Study To Monitor The Long Term Safety Of Patients Completing Protocols ACU-P08-020/020A

NCT01895088 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 271

Last updated 2017-08-01

Study results available
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Summary

This is a 2 year follow up study to monitor the long term safety of the ACI 7000PDT in subjects who are still implanted with the ACI and have successfully completed the ACU-P08-020/020A studies.

Conditions

Interventions

DEVICE

AcuFocus Corneal Inlay ACI 7000 PDT

Inlay implanted in cornea for improvement of near vision

Sponsors & Collaborators

  • AcuFocus, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel Durrie, M.D. · Durrie Vision

  • Chad Betts, M.D., R.Ph · MacDonald Eye Associates

  • Vance Thompson, M.D. · Vance Thompson Vision

  • Jay Pepose, M.D. · Pepose Vision Institute

  • Kevin Waltz, M.D. · Eye Surgeons of Indiana

  • John Vukich, M.D. · Davis Duehr Dean

  • Peter Hersh, M.D. · Cornea and Laser Eye Institute

  • Thomas Tooma, M.D. · NVision

  • Colman Kraff, M.D. · Kraff Eye Institute

  • Robert Maloney, M.D. · Maloney Vision Institute

  • Scott MacRae, M.D. · University of Rochester Eye Institute - Strong Vision

  • Gary Foster, M.D. · Eye Center of Northern Colorado

  • Phillip Hoopes, Sr., M.D. · Hoopes Vision

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2015-04-30
Completion
2015-08-31

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 NCT01895088 on ClinicalTrials.gov