A Clinical Study of the ACRYSOF® IQ Extended Depth of Focus Intraocular Lens (IOL)

Completed · Not applicable

Conditions studied: Cataract

In brief

The purpose of the study is to demonstrate the safety and performance of ACRYSOF IQ extended depth of focus (EDF) intraocular lens (IOL) at Month 6. Depth of focus (DOF) is the amount of focal plane displacement behind a lens that does not degrade the image quality of a distant object. A larger DOF allows sharp images of closer objects and may provide improved vision at intermediate and near distances.

Key facts

Study ID

NCT03274986

Run by

Alcon Research

People needed

242

Starts

2017-10-11

Expected to finish

2018-10-16

Last updated by the study team

2020-04-07

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logarithm of the minimum angle of resolution (logMAR) (20/40 Snellen) or worse either with or without a glare source present (e.g., Brightness Acuity Tester)
• Preoperative regular astigmatism of < 1.0 D in both eyes
• Clear intraocular media other than cataract
• Diagnosed with cataract in both eyes
• Planned cataract removal by routine small incision surgery
• Calculated lens power between 18.0 and 25.0 diopter (D) [when targeted for emmetropia (0.0 D)]
• Willing and able to complete all required postoperative visits
• Able to comprehend and sign an ethics committee-approved statement of informed consent
• Potential postoperative BCDVA of 0.2 logMAR (20/32 Snellen) or better in each eye based on Investigator's medical opinion.

You may not qualify if…

• History of eye pathology and/or inflammation, as specified in the protocol
• Clinically significant/severe ocular surface disease that would affect study measurements based on Investigator expert medical opinion
• History of previous intraocular or corneal surgery
• Pregnant/lactating or has another condition with associated fluctuation of hormones that could lead to refractive changes
• Taking systemic medications that in the Investigator's best medical judgment may confound the outcome or increase the risk to the subject.

Where it is running

• Alcon Investigative Site — Birmingham, Alabama, United States
• Alcon Investigative Site — Fort Collins, Colorado, United States
• Alcon Investigative Site — Bradenton, Florida, United States
• Alcon Investigative Site — Sebring, Florida, United States
• Alcon Investigative Site — Gainesville, Georgia, United States
• Alcon Investigative Site — Rock Island, Illinois, United States
• Alcon Investigative Site — Cincinnati, Ohio, United States
• Alcon Investigative Site — Allenwood, Pennsylvania, United States
• Alcon Investigative Site — Kingston, Pennsylvania, United States
• Alcon Investigative Site — West Mifflin, Pennsylvania, United States
• Alcon Investigative Site — Sioux Falls, South Dakota, United States

Full record on ClinicalTrials.gov

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