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 ]
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