Clinical trial NCT06285695: Clareon Toric Study (T2-T9)
Official title: Clareon Toric Single Arm Study (T2-T9)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aphakia
Corneal Astigmatism
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2024-02-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 (3 years follow-up). The overall study duration is expected to be approximately 4 years. This study will be conducted in Canada.

Eligibility 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.

Primary outcomes:
measure: Mean monocular best corrected distance visual acuity (BCDVA)
timeFrame: Month 6, Year 1, Year 3 (post implantation)
Secondary outcomes:
measure: Mean monocular absolute residual refractive cylinder
timeFrame: Month 3, Month 6, Year 1, Year 3 (post implantation)
measure: Mean absolute IOL rotation from previous visit
timeFrame: Month 1 to Month 3, Month 3 to Month 6, Month 6 to Year 1, Year 1 to Year 3 (post implantation)
measure: Mean absolute IOL rotation from end of surgery supine baseline to each subsequent visit
timeFrame: Baseline, Day 1, Week 1, Month 1, Month 3, Month 6, Year 1, Year 3 (post implantation)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Gimbel Eye Centre
state: Alberta
city: Concord
country: Canada
facility: Uptown Eye Specialists
state: Ontario
city: Oakville
country: Canada
facility: Prism Eye Institute
state: Ontario
city: Boisbriand
country: Canada
facility: Laurentians Eye Institute
state: Quebec
city: Montréal
country: Canada
facility: Bellevue
state: Quebec
city: Montréal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Management Operations, Surgical
role: STUDY_DIRECTOR
References: