At a glance
ClinicalIndex Comparison RecordN/ACompleted· 271 enrolled
Drug / intervention
AcuFocus Corneal Inlay ACI 7000 PDTdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Continuation Study To Monitor The Long Term Safety Of The AcuFocus ™ ACI 7000PDT Patients Completing Protocols ACU-P08-020/020A
In Brief
A clinical study evaluating AcuFocus Corneal Inlay ACI 7000 PDT for Presbyopia. Completed, enrolled 271 participants across 13 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPresbyopia
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2011
First PostedJul 2013
Primary CompletionApr 2015
Study CompletionAug 2015
TodayJul 2026
First PostedJul 10, 2013
Enrollment StartMay 1, 2011
Primary CompletionApr 1, 2015
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 13.0 years ago
Interventions
AcuFocus Corneal Inlay ACI 7000 PDTdevice
Inlay implanted in cornea for improvement of near vision