NCT06258707

Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL

Bicentric Clinical Investigation to Assess Safety and Performance of a Hydrophobic Acrylic Enhanced Monofocal Intraocular Lens.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (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 LuxBoost intraocular lenses compared with the LuxGood Monofocal lens.

Detailed description

The study purpose is to demonstrate safety and performance after bilateral implantation of LuxBoost intraocular lenses. The device under investigation is a hydrophobic acrylic monofocal intraocular lens (IOL) manufactured by the sponsor of this study.

Conditions

• Aphakia

Interventions

Type	Name	Description
DEVICE	LuxBoost 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: 2024-10-14
• Primary completion: 2026-12-15
• Completion: 2027-06-15
• First posted: 2024-02-14
• Last updated: 2026-02-12

Locations

2 sites across 1 country: France