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.

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.

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.