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.
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.