Clareon Toric vs Eyhance Toric

The primary purpose of this study is to compare the Clareon/Clareon Toric Intraocular Lenses (IOLs) to the Eyhance/Eyhance Toric IOLs in binocular Best Corrected Distance Visual Acuity (BCDVA) at 3 months postoperative.

Study Overview

• Status: Completed
• Conditions: Cataract; Aphakia
• Intervention / Treatment: Device: Clareon IOL; Device: Clareon Toric IOL; Procedure: Phacoemulsification surgery; Device: Eyhance IOL; Device: Eyhance Toric IOL

Detailed Description

This study will enroll adults 22 years of age and older diagnosed with cataracts in both eyes with planned bilateral cataract removal by routine small incision phacoemulsification surgery. Subjects will attend up to 7 scheduled visits: A screening visit, two operative visits, and four post-operative visits. The expected individual duration of participation in the study is 3 months.

• Study Type: Interventional
• Enrollment (Actual): 203
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Poughkeepsie, New York, United States, 12603
      • Seeta Eye Centers
  • Ohio
    • Brecksville, Ohio, United States, 44141
      • Cleveland Eye Clinic
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Carolina Eyecare Physicians, LLC
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Vision for Life
  • Texas
    • Houston, Texas, United States, 77027
      • Berkeley Eye Center
    • Houston, Texas, United States, 77008
      • Houston Eye Associates
    • Hurst, Texas, United States, 76054
      • Texas Eye Research Center
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • The Eye Institute of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Planned bilateral cataract removal by routine small incision phacoemulsification surgery;
• Planned implantation of either test or comparator IOL (per randomization) in at least one eye with approximately 1.00 - 3.00 diopter (D) of preoperative corneal astigmatism;
• Predicted postoperative astigmatism of ≤ 0.5 D in both operative eyes based on a Toric calculator;
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Any disease or pathology, other than cataract, that (in the investigator's opinion) may reduce potential Best Corrected Distance Visual Acuity (BCDVA) to a level worse than 0.2 logarithm minimum angle of resolution (logMAR);
• Clinically significant (in the investigator's opinion) corneal pathology, dry-eye or ocular surface disease that would adversely affect a) the biometry measures and/or toric calculations and b) the visual outcome;
• History of previous intraocular or corneal surgery (including laser-assisted in situ keratomileusis (LASIK));
• Any other planned ocular surgical procedures including but not limited to limbal relaxing incision (LRI), astigmatic keratotomy, LASIK, and retinal laser treatment within the study time frame;
• Other protocol-specified exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clareon/Clareon Toric; Phacoemulsification surgery, followed by implantation with Alcon Clareon Aspheric Hydrophobic Acrylic IOL or Alcon Clareon Aspheric Hydrophobic Acrylic Toric IOL, as indicated. The second eye surgery is recommended to occur within 14 days after the 1st eye surgery.	Device: Clareon IOL; Alcon Clareon Aspheric Hydrophobic Acrylic IOL for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. The lens is indicated for primary implantation in the capsular bag in the posterior chamber of the eye, replacing the natural crystalline lens. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject.; Other Names: Model SY60WF; Device: Clareon Toric IOL; Clareon Toric Aspheric Hydrophobic Acrylic Toric IOL for the visual correction of aphakia with pre-existing corneal astigmatism in adult patients in whom a cataractous lens has been removed. The lens is indicated for primary implantation in the capsular bag in the posterior chamber of the eye, replacing the natural crystalline lens. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject.; Other Names: Models CNW0T3, CNW0T4, CNW0T5, CNW0T6 as available; Procedure: Phacoemulsification surgery; Cataract removal by routine small incision phacoemulsification surgery
Active Comparator: Eyhance/Eyhance Toric; Phacoemulsification surgery, followed by implantation with TECNIS Eyhance IOL or TECNIS Eyhance Toric II IOL, as indicated. The second eye surgery is recommended to occur within 14 days after the 1st eye surgery.	Procedure: Phacoemulsification surgery; Cataract removal by routine small incision phacoemulsification surgery; Device: Eyhance IOL; TECNIS Eyhance IOL with TECNIS Simplicity Delivery System for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject.; Other Names: Model DIB00; Device: Eyhance Toric IOL; TECNIS Eyhance Toric II IOL with TECNIS Simplicity Delivery System for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire reduction in residual refractive cylinder. The lens is intended to be placed in the capsular bag. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject.; Other Names: Models DIU150, DIU225, DIU300, DIU375 as available

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Binocular Best-corrected Distance Visual Acuity (BCDVA) at 4 Meters Under Bright Lighting Conditions	Visual acuity was tested at a distance of 4 meters using a refraction chart and the correction obtained from a manifest refraction. BCDVA was measured in logarithm minimum angle of resolution (logMAR) units, with 0.00 logMar equating to 20/20 Snellen, which is considered normal distance eyesight. A lower logMAR value (more negative value) indicates better eyesight. This was a subject based assessment, and subject assigned a single score for both eyes.	Month 3 postoperative visit

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Lead, CDMA Surgical, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Actual): October 16, 2023
• Study Completion (Actual): October 16, 2023

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): October 30, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: IOL; Phacoemulsification; Cataracts
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Aphakia
• Other Study ID Numbers: ILS241-P002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No