Clareon Toric Study (T2-T9)

NCT06285695 — Not applicable, Completed, 129 participants, Alcon Research

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Clareon Toric Single Arm Study (T2-T9)

RegistryNCT06285695
StatusCompleted
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment129 (Actual)
SponsorAlcon Research (Industry)
ConditionsAphakia, Corneal Astigmatism
InterventionsClareon Toric IOL, Cataract surgery (Device, procedure)
Datesstart 2024-04-10, primary completion 2026-06-25, completion 2026-06-25, first posted 2024-02-29, last updated 2026-07-28
Locations6 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

-Summary

The purpose of this post-market study is to describe the long-term safety and performance of Clareon Toric Intraocular Lenses (IOLs).

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Clareon Toric IOLExperimentalDevice: Clareon Toric IOL; Procedure: Cataract surgeryClareon Toric IOL implanted in one or both eyes during cataract surgery
  • Clareon Toric IOL (Device), also known as Models CNW0T2, CNW0T3, CNW0T4, CNW0T5, CNW0T6, CNW0T7, CNW0T8, CNW0T9, CNA0T2, CNA0T3, CNA0T4, CNA0T5, CNA0T6, CNA0T7, CNA0T8, CNA0T9: 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
  • Cataract surgery (Procedure): Cataract extraction by phacoemulsification, followed by implantation with a Clareon Toric IOL

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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.

+Eligibility

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.

+Locations (6)

FacilityCityCountryStatus
Gimbel Eye CentreCalgary, AlbertaCanada
Uptown Eye SpecialistsConcord, OntarioCanada
Prism Eye InstituteOakville, OntarioCanada
Laurentians Eye InstituteBoisbriand, QuebecCanada
BellevueMontreal, QuebecCanada
McGill UniversityMontreal, QuebecCanada

+Investigators

  • Clinical Trial Management Operations, Surgical, Study director, Alcon Research, LLC