N/A
Completed N=271
A Continuation Study To Monitor The Long Term Safety Of Patients Completing Protocols ACU-P08-020/020A
Source: ClinicalTrials.gov NCT01895088 ↗Enrolled (actual)
271
Serious AEs
3.7%
Results posted
Jun 2017
Primary outcomePrimary: Change (Increase) in Uncorrected Near Visual Acuity — 3.1 lines of visual acuity improvement
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change (Increase) in Uncorrected Near Visual Acuity |
3.1 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01895088). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.