Trials / Completed
CompletedNCT06401551
Clareon PanOptix Pro vs. Clareon PanOptix - Study B
Contralateral Study of Clareon PanOptix Pro vs. Clareon PanOptix
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 71 (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
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. The Clareon™ PanOptix™ Pro Trifocal IOL is designed to enhance distance image quality by reducing chromatic aberration. |
| 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
- 2026-02-11
- Results posted
- 2026-01-12
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06401551. Inclusion in this directory is not an endorsement.