Clareon Toric Study (T2-T9)

Last updated: June 20, 2025
Sponsor: Alcon Research
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Astigmatism

Treatment

Cataract surgery

Clareon Toric IOL

Clinical Study ID

NCT06285695
ILS241-I001
  • Ages > 18
  • All Genders

Study Summary

The purpose of this post-market study is to describe the long-term safety and performance of Clareon Toric Intraocular Lenses (IOLs).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Able to understand and sign the informed consent form.

  • Willing and able to attend all scheduled study visits as required per protocol.

  • Cataract in one or both eyes with planned extraction by conventionalphacoemulsification.

  • Astigmatism in the operative eye(s).

  • Other protocol-defined inclusion criteria may apply.

Exclusion

Key Exclusion Criteria:

  • Women of childbearing potential, currently pregnant, intend to become pregnantduring the study, or nursing.

  • History of retinal detachment, age-related macular degeneration, glaucoma, diabeticretinopathy, or any pathologic changes associated with the optic nerve.

  • Clinically significant corneal disease that may, according to the Investigator'smedical opinion, adversely affect visual outcomes.

  • Clinically significant dry eye that would affect study measurements based on theInvestigator's expert medical opinion.

  • History of prior intraocular or corneal surgery.

  • Other protocol-defined exclusion criteria may apply.

Study Design

Total Participants: 109
Treatment Group(s): 2
Primary Treatment: Cataract surgery
Phase:
Study Start date:
April 10, 2024
Estimated Completion Date:
September 30, 2028

Study Description

Subjects will attend up to 12 scheduled visits (one preoperative visit, up to two surgical visits, and up to 9 postoperative visits) over the course of the study (3 years follow-up). The overall study duration is expected to be approximately 4 years. This study will be conducted in Canada.

Connect with a study center

  • Gimbel Eye Centre

    Calgary, Alberta T3B 0M3
    Canada

    Site Not Available

  • Uptown Eye Specialists

    Concord, Ontario L4K 2Z5
    Canada

    Site Not Available

  • Prism Eye Institute

    Oakville, Ontario L6H 0J8
    Canada

    Site Not Available

  • Laurentians Eye Institute

    Boisbriand, Quebec J7H 0E8
    Canada

    Site Not Available

  • Bellevue

    Montréal, Quebec H1V 1G5
    Canada

    Site Not Available

  • McGill University

    Montréal, Quebec R7A 3N2
    Canada

    Site Not Available

  • Contact Alcon Call Center for Trial Locations

    Fort Worth, Texas 76134
    United States

    Site Not Available

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