Trials / Recruiting
RecruitingNCT06922084
A Prospective, Randomized, Subject and Vision-assessor Masked, Multicenter Study Comparing Bilateral Clareon PanOptix, Bilateral Clareon PanOptix Pro, and Mixed Clareon PanOptix Pro/Vivity Intraocular Lens Implantation in Cataract Subjects
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- Sponsor
- Berkeley Eye Center · Academic / Other
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Accepted
Summary
Prospective, randomized, multicenter, multi-arm, subject and vision-assessor-masked, two stage study with Stage 1 as a three-arm initial enrollment period, followed by Stage 2 as a head-to-head study refined based on the Stage 1 data.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Clareon PanOptix | Bilateral Clareon PanOptix IOL implantation |
| DRUG | Clareon PanOptix PRO | Bilateral Clareon PanOptix PRO IOL implantation |
| DRUG | Mix-and-Match PanOptix/Vivity | Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye |
Timeline
- Start date
- 2025-03-17
- Primary completion
- 2026-04-01
- Completion
- 2026-04-01
- First posted
- 2025-04-10
- Last updated
- 2025-04-10
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06922084. Inclusion in this directory is not an endorsement.