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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895088
• Other study ID #: ACU-P12-020C
• Status: Completed
• Phase: N/A
• First received: May 3, 2013
• Last updated: July 11, 2016
• Start date: May 2011
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: AcuFocus, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

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.

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 information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: August 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

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:

• Patients who did not complete ACU-P08-020/020A.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• AcuFocus Corneal Inlay 7000PDT
corneal inlay

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AcuFocus, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in uncorrected near visual acuity	Visual acuity testing will be performed using an Optec Vision Tester. Subject will be asked to identify letters in the vision tester chart. Each letter read correctly is scored as one point.	2 years	Yes

External Links

•   Sponsor website