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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Continuation Study To Monitor The Long Term Safety Of The AcuFocus ™ ACI 7000PDT Patients Completing Protocols ACU-P08-020/020A

Conditions
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Presbyopia

Intervention / Treatment
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* Device: AcuFocus Corneal Inlay ACI 7000 PDT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients prev. impl. with ACI 7000 PDT<br>AcuFocus Corneal Inlay ACI 7000 PDT | Device: AcuFocus Corneal Inlay ACI 7000 PDT<br>* Inlay implanted in cornea for improvement of near vision<br>* Other names: AcuFocus KAMRA inlay;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change (Increase) in Uncorrected Near Visual Acuity | The change in the number of lines of threshold visual acuity achieved postoperatively. | Baseline and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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presbyopia