At a glance
ClinicalIndex Comparison RecordN/ACompleted· 119 enrolled
Drug / intervention
AcuFocus Corneal Inlaydevice
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 Prospective, Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of the AcuFocus Corneal Inlay (ACI)™ ACI 7000PDT in Presbyopic Subjects (OUS Study)
In Brief
A clinical study evaluating AcuFocus Corneal Inlay for Presbyopia. Completed, enrolled 119 participants across 8 sites in 6 countries.
Detailed Summary
The purpose of this study is to determine if the AcuFocus Corneal Inlay ACI 7000PDT will provide an effective method for the correction of presbyopia in patients who have normal distance vision but need a correction such as glasses or contact lenses to see clearly at near.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPresbyopia
CountriesAustralia, Austria, Germany, New Zealand, Singapore, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2009
First PostedFeb 2009
Primary CompletionOct 2013
TodayJul 2026
First PostedFeb 24, 2009
Enrollment StartJan 1, 2009
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 17.4 years ago
Interventions
AcuFocus Corneal Inlaydevice
Inlay implanted in cornea for improvement of near vision