NCT01895088

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
271

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

June 28, 2017

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

3.9 years

First QC Date

May 3, 2013

Results QC Date

April 3, 2017

Last Update Submit

July 6, 2017

Conditions

Presbyopia

Keywords

presbyopia

Outcome Measures

Primary Outcomes (1)

  • Change (Increase) in Uncorrected Near Visual Acuity

    The change in the number of lines of threshold visual acuity achieved postoperatively.

    Baseline and 2 years

Study Arms (1)

Patients prev. impl. with ACI 7000 PDT

EXPERIMENTAL

AcuFocus Corneal Inlay ACI 7000 PDT

Device: AcuFocus Corneal Inlay ACI 7000 PDT

Interventions

AcuFocus Corneal Inlay ACI 7000 PDTDEVICE

Inlay implanted in cornea for improvement of near vision

Also known as: AcuFocus KAMRA inlay
Patients prev. impl. with ACI 7000 PDT

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients must have completed participation in the ACU-P08-020/020A clinical trial.
  • Patients must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form.

You may not qualify if:

  • Patients who did not complete ACU-P08-020/020A.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

McDonald Eye Associates

Fayetteville, Arkansas, 72703, United States

Location

Maloney Vision

Los Angeles, California, 90024, United States

Location

NVision

Newport Beach, California, 92660, United States

Location

Eye Center NOCO

Fort Collins, Colorado, 80525, United States

Location

Kraff Eye Institute

Chicago, Illinois, 60602, United States

Location

Eye Surgeons of Indiana

Indianapolis, Indiana, 46256, United States

Location

Durrie Vision

Overland Park, Kansas, 66211, United States

Location

Pepose Vision Institute

Chesterfield, Missouri, 63017, United States

Location

The Cornea & Laser Eye Institute, P.A

Teaneck, New Jersey, 07666, United States

Location

University of Rochester Eye Institute - Strong Vision

Rochester, New York, 14618, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57105, United States

Location

Hoopes Vision

Sandy City, Utah, 84070, United States

Location

Davis Duehr Dean

Madison, Wisconsin, 53715, United States

Location

Related Links

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Eugenia Thomas, Director Clinical Trials
Organization
AcuFocus, Inc.
nthomas@acufocus.com
9495859511

Study Officials

  • Daniel Durrie, M.D.

    Durrie Vision

    PRINCIPAL INVESTIGATOR

  • Chad Betts, M.D., R.Ph

    MacDonald Eye Associates

    PRINCIPAL INVESTIGATOR

  • Vance Thompson, M.D.

    Vance Thompson Vision

    PRINCIPAL INVESTIGATOR

  • Jay Pepose, M.D.

    Pepose Vision Institute

    PRINCIPAL INVESTIGATOR

  • Kevin Waltz, M.D.

    Eye Surgeons of Indiana

    PRINCIPAL INVESTIGATOR

  • John Vukich, M.D.

    Davis Duehr Dean

    PRINCIPAL INVESTIGATOR

  • Peter Hersh, M.D.

    Cornea and Laser Eye Institute

    PRINCIPAL INVESTIGATOR

  • Thomas Tooma, M.D.

    NVision

    PRINCIPAL INVESTIGATOR

  • Colman Kraff, M.D.

    Kraff Eye Institute

    PRINCIPAL INVESTIGATOR

  • Robert Maloney, M.D.

    Maloney Vision Institute

    PRINCIPAL INVESTIGATOR

  • Scott MacRae, M.D.

    University of Rochester Eye Institute - Strong Vision

    PRINCIPAL INVESTIGATOR

  • Gary Foster, M.D.

    Eye Center of Northern Colorado

    PRINCIPAL INVESTIGATOR

  • Phillip Hoopes, Sr., M.D.

    Hoopes Vision

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2013

First Posted

July 10, 2013

Study Start

May 1, 2011

Primary Completion

April 1, 2015

Study Completion

August 1, 2015

Last Updated

August 1, 2017

Results First Posted

June 28, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

US(13)