Clinical trial NCT01895088: A Continuation Study To Monitor The Long Term Safety Of Patients Completing Protocols ACU-P08-020/020A
Official title: A Continuation Study To Monitor The Long Term Safety Of The AcuFocus ™ ACI 7000PDT Patients Completing Protocols ACU-P08-020/020A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Keywords: presbyopia
Lead sponsor: AcuFocus, Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-10
Enrollment: 271
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change (Increase) in Uncorrected Near Visual Acuity
timeFrame: Baseline and 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: McDonald Eye Associates
state: Arkansas
city: Los Angeles
country: United States
facility: Maloney Vision
state: California
city: Newport Beach
country: United States
facility: NVision
state: California
city: Fort Collins
country: United States
facility: Eye Center NOCO
state: Colorado
city: Chicago
country: United States
facility: Kraff Eye Institute
state: Illinois
city: Indianapolis
country: United States
facility: Eye Surgeons of Indiana
state: Indiana
city: Overland Park
country: United States
facility: Durrie Vision
state: Kansas
city: Chesterfield
country: United States
facility: Pepose Vision Institute
state: Missouri
city: Teaneck
country: United States
facility: The Cornea & Laser Eye Institute, P.A
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester Eye Institute - Strong Vision
state: New York
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
city: Sandy City
country: United States
facility: Hoopes Vision
state: Utah
city: Madison
country: United States
facility: Davis Duehr Dean
state: Wisconsin
Study officials:
affiliation: Durrie Vision
name: Daniel Durrie, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: MacDonald Eye Associates
name: Chad Betts, M.D., R.Ph
role: PRINCIPAL_INVESTIGATOR
affiliation: Vance Thompson Vision
name: Vance Thompson, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Pepose Vision Institute
name: Jay Pepose, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Eye Surgeons of Indiana
name: Kevin Waltz, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Davis Duehr Dean
name: John Vukich, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cornea and Laser Eye Institute
name: Peter Hersh, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: NVision
name: Thomas Tooma, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kraff Eye Institute
name: Colman Kraff, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Maloney Vision Institute
name: Robert Maloney, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester Eye Institute - Strong Vision
name: Scott MacRae, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Eye Center of Northern Colorado
name: Gary Foster, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hoopes Vision
name: Phillip Hoopes, Sr., M.D.
role: PRINCIPAL_INVESTIGATOR
References: