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

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.