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

Not Applicable

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Patients prev. impl. with ACI 7000 PDT	AcuFocus Corneal Inlay ACI 7000 PDT	AcuFocus Corneal Inlay ACI 7000 PDT

Primary Outcome Measures

Name	Time	Method
Change (Increase) in Uncorrected Near Visual Acuity	Baseline and 2 years	The change in the number of lines of threshold visual acuity achieved postoperatively.

Secondary Outcome Measures

Name	Time	Method

Locations (13): Pepose Vision Institute
🇺🇸
Chesterfield, Missouri, United States
The Cornea & Laser Eye Institute, P.A
🇺🇸
Teaneck, New Jersey, United States
Davis Duehr Dean
🇺🇸
Madison, Wisconsin, United States
McDonald Eye Associates
🇺🇸
Fayetteville, Arkansas, United States
Hoopes Vision
🇺🇸
Sandy City, Utah, United States
Vance Thompson Vision
🇺🇸
Sioux Falls, South Dakota, United States
Maloney Vision
🇺🇸
Los Angeles, California, United States
NVision
🇺🇸
Newport Beach, California, United States
Kraff Eye Institute
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Chicago, Illinois, United States
Eye Surgeons of Indiana
🇺🇸
Indianapolis, Indiana, United States
University of Rochester Eye Institute - Strong Vision
🇺🇸
Rochester, New York, United States
Eye Center NOCO
🇺🇸
Fort Collins, Colorado, United States
Durrie Vision
🇺🇸
Overland Park, Kansas, United States