Post-approval Follow-up Study of the IC-8 Apthera Intraocular Lens (IOL)

Completed

Conditions studied: Cataract, Presbyopia

In brief

The purpose of this study is to evaluate the long-term safety of the IC-8 Apthera intraocular lens (IOL).

Key facts

Study ID

NCT05758883

Run by

AcuFocus, Inc.

People needed

196

Starts

2023-01-12

Expected to finish

2024-02-16

Last updated by the study team

2024-04-02

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Enrolled in Investigational Device Exemption (IDE) G180075 study and implanted with the IC-8 Apthera intraocular lens (IOL)
• Able to comprehend and have signed a statement of informed consent
• Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit(s)

You may not qualify if…

• There are no exclusion criteria for this study

Where it is running

• Fishkind, Bakewell, Maltzman, Hunter & Associates Eye Care & Surgery Center — Tucson, Arizona, United States
• Empire Eye & Laser Center — Bakersfield, California, United States
• Harvard Eye Associates — Laguna Hills, California, United States
• Altos Eye Physicians — Los Altos, California, United States
• Advanced Vision Care — Los Angeles, California, United States
• Eye Center of Northern Colorado — Fort Collins, Colorado, United States
• Chu Vision Institute — Bloomington, Minnesota, United States
• Pepose Vision Institute — St Louis, Missouri, United States
• Kugler Vision — Omaha, Nebraska, United States
• Alterman, Modi & Wolter — Poughkeepsie, New York, United States
• Physicians Protocol — Greensboro, North Carolina, United States
• Cleveland Eye Clinic — Brecksville, Ohio, United States
• Philadelphia Eye Associates — Philadelphia, Pennsylvania, United States
• Bucci Laser Vision — Wilkes-Barre, Pennsylvania, United States
• Vance Thompson Vision — Sioux Falls, South Dakota, United States
• Baylor College of Medicine — Houston, Texas, United States
• Parkhurst NuVision — San Antonio, Texas, United States
• Hoopes Vision — Draper, Utah, United States
• Utah Eye Centers — Ogden, Utah, United States
• Virginia Eye Consultants — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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