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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01895088
Recruitment Status : Completed
First Posted : July 10, 2013
Results First Posted : June 28, 2017
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
AcuFocus, Inc.

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.

Condition or disease Intervention/treatment Phase
Presbyopia Device: AcuFocus Corneal Inlay ACI 7000 PDT Not Applicable

Detailed Description:

This is a two year follow up study designed to monitor and obtain long-term safety data of the ACI 7000PDT in subjects who participated and successfully completed the ACU-P08-020/020A studies. Subjects must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form prior to participating. This continuation study follows subjects still implanted with the ACI and includes two visits, at 12-month intervals, after subjects have been exited (at Month 36) from the ACU-P08-020/020A studies. The first visit is at Month 48 following implantation followed by a final Month 60 visit. The study parameters being measured at these two visits include:

  • Specular microscopy
  • Slit lamp and fundus examination (ocular health)
  • Corrected and uncorrected visual acuity
  • Manifest mid-point refraction
  • Corneal topography
  • Dry eye assessment
  • Mesopic and Photopic contrast sensitivity
  • Adverse events and complications

All sites participating in the ACU-P08-020/020A studies were invited to participate in the continuation study.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 271 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Continuation Study To Monitor The Long Term Safety Of The AcuFocus ™ ACI 7000PDT Patients Completing Protocols ACU-P08-020/020A
Study Start Date : May 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Experimental: Patients prev. impl. with ACI 7000 PDT
AcuFocus Corneal Inlay ACI 7000 PDT
Device: AcuFocus Corneal Inlay ACI 7000 PDT
Inlay implanted in cornea for improvement of near vision
Other Name: AcuFocus KAMRA inlay




Primary Outcome Measures :
  1. Change (Increase) in Uncorrected Near Visual Acuity [ Time Frame: Baseline and 2 years ]
    The change in the number of lines of threshold visual acuity achieved postoperatively.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01895088


Locations
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United States, Arkansas
McDonald Eye Associates
Fayetteville, Arkansas, United States, 72703
United States, California
Maloney Vision
Los Angeles, California, United States, 90024
NVision
Newport Beach, California, United States, 92660
United States, Colorado
Eye Center NOCO
Fort Collins, Colorado, United States, 80525
United States, Illinois
Kraff Eye Institute
Chicago, Illinois, United States, 60602
United States, Indiana
Eye Surgeons of Indiana
Indianapolis, Indiana, United States, 46256
United States, Kansas
Durrie Vision
Overland Park, Kansas, United States, 66211
United States, Missouri
Pepose Vision Institute
Chesterfield, Missouri, United States, 63017
United States, New Jersey
The Cornea & Laser Eye Institute, P.A
Teaneck, New Jersey, United States, 07666
United States, New York
University of Rochester Eye Institute - Strong Vision
Rochester, New York, United States, 14618
United States, South Dakota
Vance Thompson Vision
Sioux Falls, South Dakota, United States, 57105
United States, Utah
Hoopes Vision
Sandy City, Utah, United States, 84070
United States, Wisconsin
Davis Duehr Dean
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
AcuFocus, Inc.
Investigators
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Principal Investigator: 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

Additional Information:
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Responsible Party: AcuFocus, Inc.
ClinicalTrials.gov Identifier: NCT01895088     History of Changes
Other Study ID Numbers: ACU-P12-020C
First Posted: July 10, 2013    Key Record Dates
Results First Posted: June 28, 2017
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by AcuFocus, Inc.:
presbyopia
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases