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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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.

Detailed Summary:

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.


Sponsor: AcuFocus, Inc.

Current Primary Outcome: Improvement in uncorrected near visual acuity [ Time Frame: 2 years ]

Visual acuity testing will be performed using an Optec Vision Tester. Subject will be asked to identify letters in the vision tester chart. Each letter read correctly is scored as one point.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: AcuFocus, Inc.

Dates:
Date Received: May 3, 2013
Date Started: May 2011
Date Completion:
Last Updated: July 11, 2016
Last Verified: August 2015