Long-term safety and performance of Clareon Toric Intraocular Lenses
Clareon Toric Single Arm Study (T2-T9)
This study is testing how safe and effective Clareon Toric Intraocular Lenses are for people getting cataract surgery over a three-year period.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alcon Research Industry-sponsored |
| Locations | 6 sites (Calgary, Alberta and 5 other locations) |
| Trial ID | NCT06285695 on ClinicalTrials.gov |
What this trial studies
This post-market study aims to evaluate the long-term safety and performance of Clareon Toric Intraocular Lenses (IOLs) in patients undergoing cataract surgery. Participants will attend up to 12 scheduled visits over a period of three years, including preoperative, surgical, and postoperative assessments. The study will be conducted in Canada and will monitor various outcomes related to the IOLs' effectiveness and safety.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with cataracts and astigmatism in one or both eyes who are scheduled for cataract surgery.
Not a fit: Patients with significant ocular conditions such as retinal detachment, glaucoma, or those who have had prior intraocular or corneal surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of Clareon Toric IOLs for patients with cataracts and astigmatism.
How similar studies have performed: Other studies evaluating the safety and performance of intraocular lenses have shown promising results, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Calgary, Alberta and 5 other locations
- Gimbel Eye Centre — Calgary, Alberta, Canada (Recruiting)
- Uptown Eye Specialists — Concord, Ontario, Canada (Recruiting)
- Prism Eye Institute — Oakville, Ontario, Canada (Recruiting)
- Laurentians Eye Institute — Boisbriand, Quebec, Canada (Recruiting)
- Bellevue — Montréal, Quebec, Canada (Recruiting)
- McGill University — Montréal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Alcon Call Center
- Email: alcon.medinfo@alcon.com
- Phone: 1-888-451-3937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.