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New lens aims to correct both cataracts and astigmatism in one go

NCT ID NCT06285695

Disease control Sponsor: Alcon Research Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 29, 2026 · Updated 2 times

Summary

This study is checking the long-term safety and performance of a special lens called the Clareon Toric IOL, which is implanted during cataract surgery to also correct astigmatism. About 129 people with cataracts and astigmatism are taking part. The main goal is to see how well the lens improves vision and how stable it stays in the eye over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Clareon Toric intraocular lens (IOL)
What this could lead to
If successful, this could confirm that Clareon Toric IOLs are a safe and effective long-term option for correcting both cataracts and astigmatism in one surgery.
What could go wrong
This is a post-market study, so the device is already approved. The main risk is that long-term results may show unexpected issues like lens rotation or residual astigmatism, but serious problems are unlikely.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

129 people

The number who actually took part.

Started

Apr 2024

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Aphakia astigmatism cataract congenital primary aphakia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aphakia Corneal astigmatism

Contacts and locations

Locations

  • Bellevue

    Montreal, Quebec, H1V 1G5, Canada

  • Gimbel Eye Centre

    Calgary, Alberta, T3B 0M3, Canada

  • Laurentians Eye Institute

    Boisbriand, Quebec, J7H 0E8, Canada

  • McGill University

    Montreal, Quebec, R7A 3N2, Canada

  • Prism Eye Institute

    Oakville, Ontario, L6H 0J8, Canada

  • Uptown Eye Specialists

    Concord, Ontario, L4K 2Z5, Canada

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