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

Not Applicable

Completed

• Conditions: Presbyopia

• Registration Number: NCT01895088
• Lead Sponsor: AcuFocus, Inc.

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2013-05-03
• Study First Submitted QC: 2013-07-05
• Study First Posted: 2013-07-10
• Primary Completion: 2015-04
• Study Completion: 2015-08
• Results First Submitted: 2017-04-03
• Results First Submitted QC: 2017-05-25
• Results First Posted: 2017-06-28
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-06
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 271

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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.

Trial Locations

Locations (13)

McDonald Eye Associates; 🇺🇸 Fayetteville, Arkansas, United States

Maloney Vision; 🇺🇸 Los Angeles, California, United States

NVision; 🇺🇸 Newport Beach, California, United States

Eye Center NOCO; 🇺🇸 Fort Collins, Colorado, United States

Kraff Eye Institute; 🇺🇸 Chicago, Illinois, United States

Eye Surgeons of Indiana; 🇺🇸 Indianapolis, Indiana, United States

Durrie Vision; 🇺🇸 Overland Park, Kansas, United States

Pepose Vision Institute; 🇺🇸 Chesterfield, Missouri, United States

The Cornea & Laser Eye Institute, P.A; 🇺🇸 Teaneck, New Jersey, United States

University of Rochester Eye Institute - Strong Vision; 🇺🇸 Rochester, New York, United States

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