Clareon PanOptix Pro vs. Clareon PanOptix - Study A

Presbyopia Clinical Trial

Official title:

Contralateral Study of Clareon PanOptix Pro vs. Clareon PanOptix

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06400745
• Other study ID #: ILQ137-C002-A
• Status: Recruiting
• Phase: N/A
• Start date: June 18, 2024
• Est. completion date: July 2025

Study information

• Verified date: June 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 study is to evaluate the safety and effectiveness of Clareon™ PanOptix™ Pro Trifocal Intraocular Lens (IOL) compared to Clareon™ PanOptix™ Trifocal IOL.

Description:

Subjects will attend 9 scheduled study visits for a total individual duration of participation of approximately 7 months. The primary endpoint will be assessed at the Month 2 follow-up visit. Both eyes of a subject must qualify for enrollment into this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 79
• Est. completion date: July 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Key Inclusion Criteria:

• Understand and sign an ethics committee-approved informed consent form;

• Willing and able to attend all scheduled study visits as required by the protocol;

• Planned cataract surgery (both eyes);

• Preoperative corneal astigmatism less that 1.00 diopter in each eye.

• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Women of childbearing potential if currently pregnant, intend to become pregnant during the study, or are breastfeeding;

• Ocular conditions as specified in the protocol;

• Subjects who desire monovision correction.

• Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Aphakia
• Presbyopia

Intervention

Device:
• CPO Pro IOL
Intraocular lens (IOL) implanted in the eye for the visual correction of aphakia in adult patients with less than 1 diopter of preexisting corneal astigmatism in whom a cataractous lens has been removed. The IOL is intended to mitigate the effects of presbyopia on intermediate and near visual acuity while maintaining comparable distance visual acuity.
• CPO IOL
Intraocular lens (IOL) implanted in the eye for the visual correction of aphakia in adult patients with less than 1 diopter of preexisting corneal astigmatism in whom a cataractous lens has been removed. The IOL is intended to mitigate the effects of presbyopia on intermediate and near visual acuity while maintaining distance visual acuity.

Procedure:
• Cataract surgery
Extraction of the cataractous lens by phacoemulsification, followed by implantation of the IOL.

Locations

Country	Name	City	State
United States	Grosinger, Spigelman & Grey Eye Surgeons, P.C.	Bloomfield Hills	Michigan
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	Houston Eye Associates	Houston	Texas
United States	Moyes Eye Center	Kansas City	Missouri
United States	Carolina Eyecare Physicians, LLC	Mount Pleasant	South Carolina
United States	Vision for Life	Nashville	Tennessee
United States	The Eye Institute of Utah	Salt Lake City	Utah
United States	Wolstan & Goldberg Eye Associates	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA)	Visual Acuity (VA) will be assessed for each eye individually using Early Treatment Diabetic Retinopathy Study (ETDRS) reading charts at a distance of 4 meters from the subject under photopic (well-lit) conditions with correction in place. BCDVA will be measured in logarithm Minimum Angle of Resolution (logMAR). LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision), with lower scores indicating better vision.	Month 2 postoperative