Aphakia, Corneal Astigmatism
Conditions
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. The overall study duration is expected to be approximately 2 years. This study will be conducted in Canada.
Interventions
DEVICEClareon 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
PROCEDURECataract surgery
Cataract extraction by phacoemulsification, followed by implantation with a Clareon Toric IOL
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean monocular best corrected distance visual acuity (BCDVA) | Month 6, Year 1 | Visual acuity will be assessed for each eye individually using letter charts and recorded in logarithm minimum angle of resolution (logMAR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean monocular absolute residual refractive cylinder | Month 3, Month 6, Year 1 | The amount of residual astigmatism will be assessed for each eye individually using letter charts and recorded in diopters. |
Countries
Canada
Contacts
STUDY_DIRECTORClinical Trial Management Operations, Surgical
Alcon Research, LLC
Outcome results
None listed