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

NCT03274986 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2020-04-07

Study results available
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Summary

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.

Conditions

  • Cataract

Interventions

DEVICE

ACRYSOF® IQ Extended Depth of Focus IOL

Implantable IOL intending to extend the depth of focus and provide continuous functional vision from distance to near while maintaining distance vision and a visual disturbance profile comparable to a monofocal IOL.

DEVICE

ACRYSOF® IQ Monofocal IOL

Monofocal IOL implanted for long-term use over the lifetime of the pseudophakic subject

PROCEDURE

Cataract surgery

IOL bilateral implantation

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Alcon Research · Alcon Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-11
Primary Completion
2018-10-16
Completion
2018-10-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03274986 on ClinicalTrials.gov