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

A Continuation Study To Monitor The Long Term Safety Of The AcuFocus ™ ACI 7000PDT Patients Completing Protocols ACU-P08-020/020A

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.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: AcuFocus Corneal Inlay ACI 7000 PDT

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.

• Study Type: Interventional
• Enrollment (Actual): 271
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: AcuFocus KAMRA inlay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change (Increase) in Uncorrected Near Visual Acuity	The change in the number of lines of threshold visual acuity achieved postoperatively.	Baseline and 2 years

Collaborators and Investigators

• Sponsor: AcuFocus, Inc.
• Investigators: Principal Investigator: John Vukich, M.D., Davis Duehr Dean; 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: 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

Publications and helpful links

Helpful Links

• Sponsor website

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: May 3, 2013
• First Submitted That Met QC Criteria: July 5, 2013
• First Posted (Estimate): July 10, 2013

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 6, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: presbyopia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: ACU-P12-020C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO