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

Presbyopia Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. 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. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Presbyopia

• NCT number: NCT01895088
• Study type: Observational
• Source: AcuFocus, Inc.
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Completion date: August 2015