Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens

Completed · Not applicable

Conditions studied: Cataract, Presbyopia

In brief

The purpose of this study is to determine the safety and effectiveness of the IC-8 IOL implanted in one eye and a monofocal or monofocal toric IOL implanted in the fellow eye in accordance with the indication.

Key facts

Study ID

NCT03633695

Run by

AcuFocus, Inc.

People needed

453

Starts

2018-12-04

Expected to finish

2020-10-15

Last updated by the study team

2022-10-24

Who can join

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

You may qualify if…

• Minimum 22 years of age;
• 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 visits;
• Planned crystalline lens removal by phacoemulsification, with or without femtosecond laser-assisted extraction, and posterior chamber IOL implantation in both eyes;
• Cataractous lens changes as demonstrated by best-corrected visual acuity (BCDVA) of 20/40 or worse either with or without a glare source present;
• Potential for postoperative BCDVA of 20/25 or better in each eye
• Clear intraocular media, other than cataract.

You may not qualify if…

• Requiring an IC-8 intraocular lens outside the available spherical power range
• Pharmacologically dilated pupil size less than 6 mm in either eye;
• Inability to achieve stable keratometric readings for contact lens wearers
• Irregular astigmatism in either eye;
• Preoperative corneal astigmatism > 1.50 diopters in either eye
• Active or recurrent anterior segment pathology
• Presence of ocular abnormalities other than cataract as specified in the protocol
• Diagnosis of dry eye in which patients are unable to maintain eye comfort or adequate vision even with dry eye medication;
• Congenital cataracts;
• Previous corneal or intraocular surgery
• History of ocular trauma or ocular conditions expected to require retinal laser treatment or other surgical intervention;
• Systemic conditions as specified in the protocol;
• Patient is pregnant, plans to become pregnant, or is lactating
• Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit.

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
• Eye Center of North Florida — Panama City, Florida, 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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