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

AcuFocus

Status

Completed

Conditions

Presbyopia

Treatments

Device: AcuFocus Corneal Inlay ACI 7000 PDT

Study type

Interventional

Funder types

Industry

Identifiers

NCT01895088

ACU-P12-020C

Details and patient eligibility

About

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.

Full 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.

Enrollment

271 patients

Sex

All

Ages

45 to 60 years old

Volunteers

Accepts Healthy Volunteers

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