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

Alcon

Status: Completed

Conditions: Cataract

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03274986

ILI875-C002

Details and patient eligibility

About

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.

Full description

Both eyes of a subject must require cataract surgery to qualify for enrollment into this study. Subjects participating in the trial will attend a total of 9 scheduled study visits over a 7-8 month period. Of the 9 visits, 1 is preoperative, 2 are operative, and the remaining 6 are postoperative visits. Primary endpoint data will be collected at the Month 6 (Day 120-180) post second eye implantation visit.

Enrollment: 242 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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242 participants in 2 patient groups

DFT015

Experimental group

Description:

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

Treatment:

Device: ACRYSOF® IQ Extended Depth of Focus IOL

Procedure: Cataract surgery

SN60WF

Active Comparator group

Description:

ACRYSOF® IQ Monofocal IOL, bilateral implantation

Treatment:

Device: ACRYSOF® IQ Monofocal IOL

Procedure: Cataract surgery