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

NCT03274986 | Completed Results FDA Device

• 1 other identifier: ILI875-C002
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 11

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (6)

• Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) [(Logarithm of the Minimum Angle of Resolution (logMAR)] 66 Centimeters (cm) From Spectacle Plane

  Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction adjusted for optical infinity, electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 66 cm from the spectacle plane. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.

  Month 6 (120-180 days post second eye implantation)

• Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) logMAR [(4 Meters (m)] From Spectacle Plane

  VA was tested monocularly under photopic conditions using the correction obtained from the best correction and no optical infinity adjustment, electronic ETDRS charts at a distance of 4 m from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.

  Month 6 (120-180 days post second eye implantation)

• Monocular Depth of Focus (Measured in the Negative Direction From 0) at 0.20 logMAR From the Mean Defocus Curve

  Depth of focus was assessed at 4 meters under photopic (well-lit) conditions using best corrected distance refraction and added defocus. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified for the first operative eye. No formal statistical hypothesis testing was planned.

  Month 6 (120-180 days post second eye implantation)

• Percentage of Eyes Achieving Monocular Photopic DCIVA 0.20 logMAR or Better

  VA was tested monocularly under photopic conditions using best distance correction adjusted for optical infinity, electronic ETDRS charts at a distance of 66 cm from the eye. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.

  Month 6 (120-180 days post second eye implantation)

• Percentage of Subjects With Ocular Adverse Events

  An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular AEs are events localized to the eye. Cumulative and persistent serious adverse events as defined in ISO 11979-7:2014 were collected. This outcome measure was prespecified for the Model DFT015 first and second eyes. No formal statistical hypothesis testing was planned.

  Day 0 (first operative eye visit), up to Month 6 (120-180 days post second eye implantation)

• Mesopic Contrast Sensitivity

  Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed monocularly with the subject's best spectacle correction under mesopic (low, but not quite dark) conditions at a distance of 8 (2.45 m) feet from the eye at a spatial frequency of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT with and without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. A higher numeric value represented better contrast sensitivity. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.

  Month 6 (120-180 days post second eye implantation)

Secondary Outcomes (5)

• Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) (logMAR) 40 cm From Spectacle Plane

  Month 6 (120-180 days post second eye implantation)

• Percentage of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire: "Overall, in the Past 7 Days, How Often Did You Need to Wear Eyeglasses to See?"

  Month 6 (120-180 days post second eye implantation)

• Monocular Photopic Uncorrected Intermediate Visual Acuity (UCIVA) (logMAR) 66 cm From Spectacle Plane

  Month 6 (120-180 days post second eye implantation)

• Monocular Photopic Uncorrected Distance Visual Acuity (UCDVA) (logMAR)

  Month 6 (120-180 days post second eye implantation)

• Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID)

  Month 6 (120-180 days post second eye implantation)

Study Arms (2)

DFT015

EXPERIMENTAL

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

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

SN60WF

ACTIVE COMPARATOR

ACRYSOF® IQ Monofocal IOL, bilateral implantation

Device: ACRYSOF® IQ Monofocal IOL; Procedure: Cataract surgery

Interventions

ACRYSOF® IQ Extended Depth of Focus IOL 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.

Also known as: Model DFT015

DFT015

ACRYSOF® IQ Monofocal IOL DEVICE

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

Also known as: Model SN60WF

SN60WF

Cataract surgery PROCEDURE

IOL bilateral implantation

DFT015; SN60WF

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (11)

Alcon Investigative Site

Birmingham, Alabama, 35213, United States

Location

Alcon Investigative Site

Fort Collins, Colorado, 80528, United States

Location

Alcon Investigative Site

Bradenton, Florida, 34209, United States

Location

Alcon Investigative Site

Sebring, Florida, 33870, United States

Location

Alcon Investigative Site

Gainesville, Georgia, 30501, United States

Location

Alcon Investigative Site

Rock Island, Illinois, 61201, United States

Location

Alcon Investigative Site

Cincinnati, Ohio, 45242, United States

Location

Alcon Investigative Site

Allenwood, Pennsylvania, 17810, United States

Location

Alcon Investigative Site

Kingston, Pennsylvania, 18704, United States

Location

Alcon Investigative Site

West Mifflin, Pennsylvania, 15122, United States

Location

Alcon Investigative Site

Sioux Falls, South Dakota, 57108, United States

Location

Related Publications (1)

• 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.

  PMID: 35616507 DERIVED

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: CDMA Project Lead
• Organization: Alcon Research

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Alcon Research

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 7, 2017
• Study Start: October 11, 2017
• Primary Completion: October 16, 2018
• Study Completion: October 16, 2018
• Last Updated: April 7, 2020
• Results First Posted: April 7, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)