Clareon Toric Study (T2-T9)

Last updated: November 12, 2024
Sponsor: Alcon Research
Overall Status: Active - Recruiting

Phase

N/A

Condition

Astigmatism

Treatment

Clareon Toric IOL

Cataract surgery

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: 100
Treatment Group(s): 2
Primary Treatment: Clareon Toric IOL
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

    Active - Recruiting

  • Uptown Eye Specialists

    Concord, Ontario L4K 2Z5
    Canada

    Active - Recruiting

  • Prism Eye Institute

    Oakville, Ontario L6H 0J8
    Canada

    Active - Recruiting

  • Laurentians Eye Institute

    Boisbriand, Quebec J7H 0E8
    Canada

    Active - Recruiting

  • Bellevue

    Montréal, Quebec H1V 1G5
    Canada

    Active - Recruiting

  • McGill University

    Montréal, Quebec R7A 3N2
    Canada

    Active - Recruiting

  • Contact Alcon Call Center for Trial Locations

    Fort Worth, Texas 76134
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.