Clareon Toric Study (T2-T9)

N/AActive Not RecruitingNCT06285695

Alcon Research129 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

129

Conditions

Aphakia Corneal Astigmatism

Interventions

Clareon Toric IOLDEVICE

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 surgeryPROCEDURE

Cataract extraction by phacoemulsification, followed by implantation with a Clareon Toric IOL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Gimbel Eye Centre

Calgary, Alberta, Canada

Uptown Eye Specialists

Concord, Ontario, Canada

Prism Eye Institute

Oakville, Ontario, Canada

Laurentians Eye Institute

Boisbriand, Quebec, Canada

Outcomes

Primary Outcomes

Mean monocular best corrected distance visual acuity (BCDVA)

Visual acuity will be assessed for each eye individually using letter charts and recorded in logarithm minimum angle of resolution (logMAR).

Time frame: Month 6, Year 1, Year 3 (post implantation)

Secondary Outcomes

Mean monocular absolute residual refractive cylinder

The amount of residual astigmatism will be assessed for each eye individually using letter charts and recorded in diopters.

Time frame: Month 3, Month 6, Year 1, Year 3 (post implantation)

Mean absolute IOL rotation from previous visit

The difference in IOL axis of orientation from the previous visit will be assessed by a reading center and recorded in degrees.

Time frame: Month 1 to Month 3, Month 3 to Month 6, Month 6 to Year 1, Year 1 to Year 3 (post implantation)

Mean absolute IOL rotation from end of surgery supine baseline to each subsequent visit

The difference in IOL axis of orientation from baseline (end of surgery, patient laying flat) will be assessed by a reading center and recorded in degrees.

Time frame: Baseline, Day 1, Week 1, Month 1, Month 3, Month 6, Year 1, Year 3 (post implantation)

Data from ClinicalTrials.gov

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