Clareon Toric Study (T2-T9) (NCT06285695) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Clareon Toric Study (T2-T9)
Canada129 participantsStarted 2024-04-10
Plain-language summary
The purpose of this post-market study is to describe the long-term safety and performance of Clareon Toric Intraocular Lenses (IOLs).
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Mean monocular best corrected distance visual acuity (BCDVA)
Timeframe: Month 6, Year 1, Year 3 (post implantation)