NCT06285695

Clareon Toric Study (T2-T9)

Clareon Toric Single Arm Study (T2-T9)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aphakia
• Corneal Astigmatism

Interventions

Type	Name	Description
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
PROCEDURE	Cataract surgery	Cataract extraction by phacoemulsification, followed by implantation with a Clareon Toric IOL

Timeline

• Start date: 2024-04-10
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2024-02-29
• Last updated: 2025-09-18

Locations

6 sites across 1 country: Canada

Regulatory

• FDA-regulated device study