Clareon Toric vs Eyhance Toric

October 7, 2024 updated by: Alcon Research
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
203

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Binocular Best-corrected Distance Visual Acuity (BCDVA) at 4 Meters Under Bright Lighting Conditions
Time Frame: Month 3 postoperative visit
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alcon Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trial Lead, CDMA Surgical, Alcon Research, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 16, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 16, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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