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

NCT03010254 | Completed Results FDA Device

• 1 other identifier: ILI875-C001
• Study Type: interventional
• Target: 322
• Locations: 4 countries
• Sites: 21

Brief Summary

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

Conditions

Cataract

Outcome Measures

Primary Outcomes (2)

• Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeters (cm)

  Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (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 3 (70-100 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 by ISO 11979-7:2014 were collected for 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)

Secondary Outcomes (6)

• Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters (m)

  Month 3 (70-100 days post second eye implantation)

• Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm

  Month 3 (70-100 days post second eye implantation)

• Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve

  Month 3 (70-100 days post second eye implantation)

• Monocular Mesopic Contrast Sensitivity at 12 Cycles Per Degree (Cpd)

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

• Percentage of Subjects Who Respond "Never" to Question 1 of the Spectacle Use Questionnaire: "How Often Do You Wear Eyeglasses for Any Purpose?"

  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; intended for long-term use over the lifetime of the pseudophakic subject

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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (21)

Alcon Investigative Site

Sydney, New South Wales, 2150, Australia

Location

Alcon Investigative Site

Southport, Queensland, 4215, Australia

Location

Alcon Investigative Site

Footscray, Victoria, 3011, Australia

Location

Alcon Investigative Site

Hawthorn East, Victoria, 3123, Australia

Location

Alcon Investigative Site

Vancouver, British Columbia, V5Z 3N9, Canada

Location

Alcon Investigative Site

Mississauga, Ontario, L5L1W8, Canada

Location

Alcon Investigative Site

Toronto, Ontario, M3N 2V7, Canada

Location

Alcon Investigative Site

Toronto, Ontario, M5T 3A9, Canada

Location

Alcon Investigative Site

Boisbriand, QU, J7H 186, Canada

Location

Alcon Investigative Site

Québec, QU, G1S 4L8, Canada

Location

Alcon Investigative Site

Sant Cugat del Vallès, BCN, 08195, Spain

Location

Alcon Investigative Site

Jerez de la Frontera, Cadiz, 11408, Spain

Location

Alcon Investigative Site

Barcelona, 08008, Spain

Location

Alcon Investigative Site

Barcelona, 08021, Spain

Location

Alcon Investigative Site

Barcelona, 08022, Spain

Location

Alcon Investigative Site

Madrid, 28003, Spain

Location

Alcon Investigative Site

Valencia, 46015, Spain

Location

Alcon Investigative Site

Dartford, Kent, DA2 8DA, United Kingdom

Location

Alcon Investigative Site

Essex, SS0 9AG, United Kingdom

Location

Alcon Investigative Site

London, NW1 5QH, United Kingdom

Location

Alcon Investigative Site

Manchester, M13 9WL, United Kingdom

Location

Related Publications (1)

• Bala C, Poyales F, Guarro M, Mesa RR, Mearza A, Varma DK, Jasti S, Lemp-Hull J. Multicountry clinical outcomes of a new nondiffractive presbyopia-correcting IOL. J Cataract Refract Surg. 2022 Feb 1;48(2):136-143. doi: 10.1097/j.jcrs.0000000000000712.

  PMID: 34288635 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

• Senior Clinical Manager, GCRA

  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: January 3, 2017
• First Posted: January 5, 2017
• Study Start: March 21, 2017
• Primary Completion: August 17, 2018
• Study Completion: October 31, 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

ES (7); CA (6); AU (4); GB (4)