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Bicentric Clinical Investigation to Assess Safety and Performance of LuxHighAdd IOL
Sponsor: Cutting Edge SAS
Summary
The study purpose is to demonstrate safety and performance of bilateral implantation of LuxHighAdd intraocular lens compared with the LuxGood Monofocal lens.
Official title: Multicentric Clinical Investigation to Determine Safety and Efficacy of a Hydrophobic Acrylic Multifocal Intraocular Lens
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
57
Start Date
2024-12-19
Completion Date
2026-07-01
Last Updated
2025-02-12
Healthy Volunteers
No
Conditions
Interventions
LuxHighAdd IOL
Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
LuxGood IOL
Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
Locations (2)
Hôpital Fondation Adolphe de Rothschild
Paris, France
WestOphta
Rennes, France