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CompletedNCT06285695Updated Jul 28, 2026

Clareon Toric Study (T2-T9)

An interventional study of Clareon Toric IOL and Cataract surgery in Aphakia and Corneal Astigmatism, sponsored by Alcon Research. Completed at 6 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
129
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

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

02

Conditions studied

  • Aphakia
  • Corneal Astigmatism

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03

In context

Aphakia

69 studies on the registry are indexed under Aphakia; 6 are open to participants now.

This study's enrollment of 129 is above the median of 103 across 52 interventional studies indexed under Aphakia.

Browse Aphakia studies →

Lead sponsor

Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.

Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Able to understand and sign the 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 , 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.
  • 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
129 participants (actual)

Study arms

  • Experimental
    Clareon Toric IOL

    Clareon Toric IOL implanted in one or both eyes during cataract surgery

    Device: Clareon Toric IOL · Procedure: Cataract surgery

Interventions

  • DeviceClareon Toric IOL

    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

    Also known as: Models CNW0T2, CNW0T3, CNW0T4, CNW0T5, CNW0T6, CNW0T7, CNW0T8, CNW0T9, CNA0T2, CNA0T3, CNA0T4, CNA0T5, CNA0T6, CNA0T7, CNA0T8, CNA0T9

  • ProcedureCataract surgery

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

06

What researchers measure

Primary outcomes

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

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

    Time frame: Month 6, Year 1

Secondary outcomes

  1. Mean monocular absolute residual refractive cylinder

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

    Time frame: Month 3, Month 6, Year 1

07

Study locations

6 sites
  • Gimbel Eye Centre
    Calgary, Alberta T3B 0M3, Canada
  • Uptown Eye Specialists
    Concord, Ontario L4K 2Z5, Canada
  • Prism Eye Institute
    Oakville, Ontario L6H 0J8, Canada
  • Laurentians Eye Institute
    Boisbriand, Quebec J7H 0E8, Canada
  • Bellevue
    Montreal, Quebec H1V 1G5, Canada
  • McGill University
    Montreal, Quebec R7A 3N2, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06285695
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Feb 29, 2024
Start date
Apr 10, 2024
Primary completion
Jun 25, 2026
Completion
Jun 25, 2026
Last update
Jul 28, 2026

Study contacts

Clinical Trial Management Operations, Surgical
study director · Alcon Research, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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