NCT06400745

Clareon PanOptix Pro vs. Clareon PanOptix - Study A

Contralateral Study of Clareon PanOptix Pro vs. Clareon PanOptix

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Subjects will attend 9 scheduled study visits for a total individual duration of participation of approximately 6 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.

Conditions

• Aphakia
• Presbyopia

Interventions

Type	Name	Description
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.
DEVICE	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.

Timeline

• Start date: 2024-06-18
• Primary completion: 2024-12-13
• Completion: 2025-04-30
• First posted: 2024-05-06
• Last updated: 2025-12-12
• Results posted: 2025-12-12

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study