Status:
COMPLETED
A Continuation Study To Monitor The Long Term Safety Of Patients Completing Protocols ACU-P08-020/020A
Lead Sponsor:
AcuFocus, Inc.
Conditions:
Presbyopia
Eligibility:
All Genders
45-60 years
Phase:
NA
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 Description
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. Subject...
Eligibility Criteria
Inclusion
- 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
- Patients who did not complete ACU-P08-020/020A.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
271 Patients enrolled
Trial Details
Trial ID
NCT01895088
Start Date
May 1 2011
End Date
August 1 2015
Last Update
August 1 2017
Active Locations (13)
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1
McDonald Eye Associates
Fayetteville, Arkansas, United States, 72703
2
Maloney Vision
Los Angeles, California, United States, 90024
3
NVision
Newport Beach, California, United States, 92660
4
Eye Center NOCO
Fort Collins, Colorado, United States, 80525