Clareon Toric Study (T2-T9)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Corneal Astigmatism; Aphakia
• Intervention / Treatment: Device: Clareon Toric IOL; Procedure: Cataract surgery

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 (3 years follow-up). The overall study duration is expected to be approximately 4 years. This study will be conducted in Canada.

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Device: Clareon 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; Other Names: Models CNW0T2, CNW0T3, CNW0T4, CNW0T5, CNW0T6, CNW0T7, CNW0T8, CNW0T9, CNA0T2, CNA0T3, CNA0T4, CNA0T5, CNA0T6, CNA0T7, CNA0T8, CNA0T9; Procedure: Cataract surgery; Cataract extraction by phacoemulsification, followed by implantation with a Clareon Toric IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Month 3, Month 6, Year 1, Year 3 (post implantation)
Mean absolute IOL rotation from previous visit	The difference in IOL axis of orientation from the previous visit will be assessed by a reading center and recorded in degrees.	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	The difference in IOL axis of orientation from baseline (end of surgery, patient laying flat) will be assessed by a reading center and recorded in degrees.	Baseline, Day 1, Week 1, Month 1, Month 3, Month 6, Year 1, Year 3 (post implantation)

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Management Operations, Surgical, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Lens Diseases; Astigmatism; Aphakia; Surgical Procedures, Operative; Ophthalmologic Surgical Procedures; Refractive Surgical Procedures; Cataract Extraction
• Other Study ID Numbers: ILS241-I001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes