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Completed

NCT Number: NCT06285695

Clareon Toric Study (T2-T9)

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

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Key information

Conditions

Aphakia Astigmatism Corneal Astigmatism Eye Diseases Lens Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gimbel Eye Centre, Calgary, Alberta, Canada

Loading trial locations.

About this study

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. The overall study duration is expected to be approximately 2 years. This study will be conducted in Canada.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 conventional phacoemulsification.
  • Astigmatism in the operative eye(s).
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Women of childbearing potential, currently pregnant, intend to become pregnant during the study, or nursing.
  • History of retinal detachment, age-related macular degeneration, glaucoma, diabetic retinopathy, or any pathologic changes associated with the optic nerve.
  • Clinically significant corneal disease that may, according to the Investigator's medical opinion, adversely affect visual outcomes.
  • Clinically significant dry eye that would affect study measurements based on the Investigator's expert medical opinion.
  • History of prior intraocular or corneal surgery.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Clareon Toric IOL

Device

Aspheric hydrophobic acrylic IOL placed in the capsular bag in the posterior chamber of the eye during cataract surgery for the visual correction of aphakia and preexisting corneal astigmatism

Other names: Models CNW0T2, CNW0T3, CNW0T4, CNW0T5, CNW0T6, CNW0T7, CNW0T8, CNW0T9, CNA0T2, CNA0T3, CNA0T4, CNA0T5, CNA0T6, CNA0T7, CNA0T8, CNA0T9

cataract surgery

Procedure

Cataract extraction by phacoemulsification, followed by implantation with a Clareon Toric IOL

Primary outcomes

  1. Mean monocular best corrected distance visual acuity (BCDVA)

    Time frame: Month 6, Year 1

    Visual acuity will be assessed for each eye individually using letter charts and recorded in logarithm minimum angle of resolution (logMAR).

Secondary outcomes

  1. Mean monocular absolute residual refractive cylinder

    Time frame: Month 3, Month 6, Year 1

    The amount of residual astigmatism will be assessed for each eye individually using letter charts and recorded in diopters.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Clareon Toric Single Arm Study (T2-T9)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 29, 2024
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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