Clareon Toric Study (T2-T9)

Not Applicable

Recruiting

• Conditions: Corneal Astigmatism; Aphakia
• Interventions: Device: Clareon Toric IOL; Procedure: Cataract surgery

• Registration Number: NCT06285695
• Lead Sponsor: Alcon Research

Brief Summary

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

Study Timeline

• Study First Submitted: 2024-02-23
• Study First Submitted QC: 2024-02-23
• Study First Posted: 2024-02-29
• Study Start: 2024-04-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-13
• Primary Completion: 2028-09
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clareon Toric IOL	Clareon Toric IOL	Clareon Toric IOL implanted in one or both eyes during cataract surgery
Clareon Toric IOL	Cataract surgery	Clareon Toric IOL implanted in one or both eyes during cataract surgery

Primary Outcome Measures

Name	Time	Method
Mean monocular best corrected distance visual acuity (BCDVA)	Month 6, Year 1, Year 3 (post implantation)	Visual acuity will be assessed for each eye individually using letter charts and recorded in logarithm minimum angle of resolution (logMAR).

Secondary Outcome Measures

Name	Time	Method
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)	The difference in IOL axis of orientation from the previous visit will be assessed by a reading center and recorded in degrees.
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)	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.
Mean monocular absolute residual refractive cylinder	Month 3, Month 6, Year 1, Year 3 (post implantation)	The amount of residual astigmatism will be assessed for each eye individually using letter charts and recorded in diopters.

Trial Locations

Locations (6)

Uptown Eye Specialists; 🇨🇦 Concord, Ontario, Canada

Gimbel Eye Centre; 🇨🇦 Calgary, Alberta, Canada

Prism Eye Institute; 🇨🇦 Oakville, Ontario, Canada

Laurentians Eye Institute; 🇨🇦 Boisbriand, Quebec, Canada

Bellevue; 🇨🇦 Montréal, Quebec, Canada

McGill University; 🇨🇦 Montréal, Quebec, Canada