Trials / Recruiting
RecruitingNCT06446817
Bicentric Clinical Investigation to Assess Safety and Performance of LuxHighAdd IOL
Multicentric Clinical Investigation to Determine Safety and Efficacy of a Hydrophobic Acrylic Multifocal Intraocular Lens
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 57 (estimated)
- Sponsor
- Cutting Edge SAS · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
The study purpose is to demonstrate safety and performance of bilateral implantation of LuxHighAdd intraocular lens compared with the LuxGood Monofocal lens.
Detailed description
The study purpose is to demonstrate safety and performance after bilateral implantation of LuxHighAdd intraocular lenses. The device under investigation is a hydrophobic acrylic multifocal intraocular lens (IOL) manufactured by the sponsor of this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LuxHighAdd IOL | Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens. |
| DEVICE | LuxGood IOL | Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens. |
Timeline
- Start date
- 2024-12-19
- Primary completion
- 2026-03-01
- Completion
- 2026-07-01
- First posted
- 2024-06-06
- Last updated
- 2025-02-12
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT06446817. Inclusion in this directory is not an endorsement.