Clareon Toric Study (T2-T9)
Status
Conditions
Treatments
Details and patient eligibility
About
The purpose of this post-market study is to describe the long-term safety and performance of Clareon Toric Intraocular Lenses (IOLs).
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
100 participants in 1 patient group
Trial contacts and locations
Loading...
Central trial contact
Alcon Call Center
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal