Clareon Toric Single Arm Study (T2-T9)
| Registry | NCT06285695 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 129 (Actual) |
| Sponsor | Alcon Research (Industry) |
| Conditions | Aphakia, Corneal Astigmatism |
| Interventions | Clareon Toric IOL, Cataract surgery (Device, procedure) |
| Dates | start 2024-04-10, primary completion 2026-06-25, completion 2026-06-25, first posted 2024-02-29, last updated 2026-07-28 |
| Locations | 6 sites in Canada |
Related Papers Related Patents Related Grants Related Experts
All trials for Aphakia All trials for Corneal Astigmatism All trials of Clareon Toric IOL All trials of Cataract surgery
The purpose of this post-market study is to describe the long-term safety and performance of Clareon Toric Intraocular Lenses (IOLs).
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Clareon Toric IOL | Experimental | Device: Clareon Toric IOL; Procedure: Cataract surgery | Clareon Toric IOL implanted in one or both eyes during cataract surgery |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Gimbel Eye Centre | Calgary, Alberta | Canada | |
| Uptown Eye Specialists | Concord, Ontario | Canada | |
| Prism Eye Institute | Oakville, Ontario | Canada | |
| Laurentians Eye Institute | Boisbriand, Quebec | Canada | |
| Bellevue | Montreal, Quebec | Canada | |
| McGill University | Montreal, Quebec | Canada |