NCT01895088

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 271 (actual)
• Sponsor: AcuFocus, Inc. · Industry
• Sex: All
• Age: 45 Years – 60 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DEVICE	AcuFocus Corneal Inlay ACI 7000 PDT	Inlay implanted in cornea for improvement of near vision

Timeline

• Start date: 2011-05-01
• Primary completion: 2015-04-01
• Completion: 2015-08-01
• First posted: 2013-07-10
• Last updated: 2017-08-01
• Results posted: 2017-06-28

Locations

13 sites across 1 country: United States