A Clinical Study of the ACRYSOF® IQ EDF Intraocular Lens (IOL)

Alcon

Status: Completed

Conditions: Cataract

Treatments: Device: ACRYSOF® IQ Extended Depth of Focus IOL; Procedure: Cataract surgery; Device: ACRYSOF® IQ Monofocal IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT03010254

ILI875-C001

Details and patient eligibility

About

The purpose of the study is to demonstrate the safety and performance of the ACRYSOF® IQ EDF IOL.

Full description

Both eyes will be implanted. The second eye implantation will occur a minimum of 7 calendar days and a maximum of 28 calendar days from the first eye implantation.

Enrollment: 322 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to understand and sign an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB) approved Informed Consent Form;
• Diagnosed with cataract in both eyes;
• Planned cataract removal by routine small incision surgery;
• Calculated IOL power is within the clinical study supply range (18.0-25.0 diopter (D) in 0.5 D steps);
• Preoperative regular astigmatism of less than 1.0 D.

Exclusion criteria

• Pregnancy or lactation current or planned during the course of the study;
• History of anterior segment (corneal, anterior chamber, sulcus) or posterior segment (uveal, vitreo-retinal) pathology including retinal vascular occlusive disease, retinal detachment or peripheral retinal laser photocoagulation, age-related macular degeneration (ARMD), glaucoma (uncontrolled or controlled with medication) or ocular hypertension, diabetic retinopathy, retinitis pigmentosa and any optic nerve pathology.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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322 participants in 2 patient groups

DFT015

Experimental group

Description:

ACRYSOF® IQ Extended Depth of Focus Intraocular lens (IOL), bilateral implantation

Treatment:

Procedure: Cataract surgery

Device: ACRYSOF® IQ Extended Depth of Focus IOL

SN60WF

Active Comparator group

Description:

ACRYSOF® IQ Monofocal IOL, bilateral implantation

Treatment:

Device: ACRYSOF® IQ Monofocal IOL

Procedure: Cataract surgery