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

NCT ID: NCT03274986

Last Updated: 2020-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-11
• Study Completion Date: 2018-10-16

Brief 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.

Detailed 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.

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DFT015

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

Group Type: EXPERIMENTAL

ACRYSOF® IQ Extended Depth of Focus IOL

Intervention Type: DEVICE

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.

Cataract surgery

Intervention Type: PROCEDURE

IOL bilateral implantation

SN60WF

ACRYSOF® IQ Monofocal IOL, bilateral implantation

Group Type: ACTIVE_COMPARATOR

ACRYSOF® IQ Monofocal IOL

Intervention Type: DEVICE

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

Cataract surgery

Intervention Type: PROCEDURE

IOL bilateral implantation

Interventions

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.

Intervention Type: DEVICE

ACRYSOF® IQ Monofocal IOL

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

Intervention Type: DEVICE

Cataract surgery

IOL bilateral implantation

Intervention Type: PROCEDURE

Other Intervention Names

Model DFT015; Model SN60WF

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alcon Research

Role: STUDY_DIRECTOR

Alcon Research

Locations

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

Countries

United States

References

McCabe C, Berdahl J, Reiser H, Newsom TH, Cibik L, Koch D, Lemp-Hull J, Jasti S. Clinical outcomes in a U.S. registration study of a new EDOF intraocular lens with a nondiffractive design. J Cataract Refract Surg. 2022 Nov 1;48(11):1297-1304. doi: 10.1097/j.jcrs.0000000000000978. Epub 2022 May 26.

Reference Type: DERIVED

PMID: 35616507 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

ILI875-C002

Identifier Type: -

Identifier Source: org_study_id