Clareon Toric Study (T2-T9)

Aphakia Clinical Trial

Official title:

Clareon Toric Single Arm Study (T2-T9)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06285695
• Other study ID #: ILS241-I001
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2024
• Est. completion date: April 2028

Study information

• Verified date: April 2024
• Source: Alcon Research
• Contact: Alcon Call Center
• Phone: 1-888-451-3937
• Email: alcon.medinfo[@]alcon.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2028
• Est. primary completion date: April 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aphakia
• Astigmatism
• Corneal Astigmatism

Intervention

Device:
• Clareon 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

Procedure:
• Cataract surgery
Cataract extraction by phacoemulsification, followed by implantation with a Clareon Toric IOL

Locations

Country	Name	City	State
Canada	Laurentians Eye Institute	Boisbriand	Quebec
Canada	Gimbel Eye Centre	Calgary	Alberta
Canada	Uptown Eye Specialists	Concord	Ontario
Canada	Bellevue	Montréal	Quebec
Canada	McGill University	Montréal	Quebec
Canada	Prism Eye Institute	Oakville	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Month 6, Year 1, Year 3 (post implantation)
Secondary	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.	Month 3, Month 6, Year 1, Year 3 (post implantation)
Secondary	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.	Month 1 to Month 3, Month 3 to Month 6, Month 6 to Year 1, Year 1 to Year 3 (post implantation)
Secondary	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.	Baseline, Day 1, Week 1, Month 1, Month 3, Month 6, Year 1, Year 3 (post implantation)