NCT06285695

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
26mo left

Started Apr 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Apr 2024Jul 2028

First Submitted

Initial submission to the registry

February 23, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

April 10, 2024

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

4.2 years

First QC Date

February 23, 2024

Last Update Submit

September 15, 2025

Conditions

AphakiaCorneal Astigmatism

Outcome Measures

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).

    Month 6, Year 1, Year 3 (post implantation)

Secondary Outcomes (3)

  • Mean monocular absolute residual refractive cylinder

    Month 3, Month 6, Year 1, Year 3 (post implantation)

  • Mean absolute IOL rotation from previous visit

    Month 1 to Month 3, Month 3 to Month 6, Month 6 to Year 1, Year 1 to Year 3 (post implantation)

  • Mean absolute IOL rotation from end of surgery supine baseline to each subsequent visit

    Baseline, Day 1, Week 1, Month 1, Month 3, Month 6, Year 1, Year 3 (post implantation)

Study Arms (1)

Clareon Toric IOL

EXPERIMENTAL

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

Device: Clareon Toric IOLProcedure: Cataract surgery

Interventions

Clareon Toric IOLDEVICE

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
Clareon Toric IOL
Cataract surgeryPROCEDURE

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

Clareon Toric IOL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Gimbel Eye Centre

Calgary, Alberta, T3B 0M3, Canada

Location

Uptown Eye Specialists

Concord, Ontario, L4K 2Z5, Canada

Location

Prism Eye Institute

Oakville, Ontario, L6H 0J8, Canada

Location

Laurentians Eye Institute

Boisbriand, Quebec, J7H 0E8, Canada

Location

Bellevue

Montreal, Quebec, H1V 1G5, Canada

Location

McGill University

Montreal, Quebec, R7A 3N2, Canada

Location

MeSH Terms

Conditions

AphakiaAstigmatism

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Clinical Trial Management Operations, Surgical

    Alcon Research, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2024

First Posted

February 29, 2024

Study Start

April 10, 2024

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(6)