AphakiaNCT06285695
Clareon Toric Study (T2-T9)
A study testing Clareon Toric IOL and Cataract surgery in people with Aphakia and Corneal Astigmatism, run by Alcon Research at 6 sites in Canada.
Trial summary
The purpose of this post-market study is to describe the long-term safety and performance of Clareon Toric Intraocular Lenses (IOLs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphakia, Corneal Astigmatism
- What is being tested?
- Clareon Toric IOL and Cataract surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 6 sitesCanada
- Study dates
- 10 Apr 2024to 25 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Laurentians Eye Institute
Boisbriand, Quebec, J7H 0E8
Gimbel Eye Centre
Calgary, Alberta, T3B 0M3
Uptown Eye Specialists
Concord, Ontario, L4K 2Z5
Bellevue
Montreal, Quebec, H1V 1G5
McGill University
Montreal, Quebec, R7A 3N2
Prism Eye Institute
Oakville, Ontario, L6H 0J8
About this study
Official title: Clareon Toric Single Arm 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).
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.
- Conditions
- Aphakia, Corneal Astigmatism
- Being tested
- Clareon Toric IOL, Cataract surgery
- Medical subject headings
- Aphakia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clareon Toric IOLDevice
Also called Models CNW0T2, CNW0T3, CNW0T4, CNW0T5, CNW0T6, CNW0T7, CNW0T8, CNW0T9, CNA0T2, CNA0T3, CNA0T4, CNA0T5, CNA0T6, CNA0T7, CNA0T8, CNA0T9
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
Cataract surgeryProcedure or surgery
Cataract extraction by phacoemulsification, followed by implantation with a Clareon Toric IOL
| Study group | Role | What they receive |
|---|---|---|
| Clareon Toric IOL | Experimental | Clareon Toric IOL implanted in one or both eyes during cataract surgery Receives: Device: Clareon Toric IOL; Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Month 3, Month 6, Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start10 Apr 2024
- Primary completion25 Jun 2026
- Study completion25 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphakiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management Operations, Surgical, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285695
- Sponsor's protocol ID
- ILS241-I001
- Status last verified
- Jul 2026
- First submitted
- 23 Feb 2024
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clareon Toric Single Arm Study (T2-T9)
- ClinicalTrials.gov ID
- NCT06285695
- Acronym / sponsor ID
- ILS241-I001
- Conditions
- Aphakia, Corneal Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 25 Jun 2026 (actual)
- Study completion
- 25 Jun 2026 (actual)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this post-market study is to describe the long-term safety and performance of Clareon Toric Intraocular Lenses (IOLs).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clareon Toric IOL | Experimental | Device: Clareon Toric IOL, Procedure: Cataract surgeryClareon Toric IOL implanted in one or both eyes during cataract surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clareon Toric IOLAlso: Models CNW0T2, CNW0T3, CNW0T4, CNW0T5, CNW0T6, CNW0T7, CNW0T8, CNW0T9, CNA0T2, CNA0T3, CNA0T4, CNA0T5, CNA0T6, CNA0T7, CNA0T8, CNA0T9Aspheric 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 | Device | Clareon Toric IOL |
| Cataract surgeryCataract extraction by phacoemulsification, followed by implantation with a Clareon Toric IOL | Procedure or surgery | Clareon Toric IOL |
Primary outcome
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).
1 secondary outcome
Mean monocular absolute residual refractive cylinder
Time frame: Month 3, Month 6, Year 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management Operations, Surgical study director
Alcon Research, LLC
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clareon Toric IOL and Cataract surgery in people with Aphakia and Corneal Astigmatism, run by Alcon Research at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean monocular best corrected distance visual acuity (BCDVA) (time frame: Month 6, Year 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.