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Bicentric Clinical Investigation to Assess Safety and Performance of LuxHighAdd IOL

NCT06446817 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2025-02-12

No results posted yet for this study

Summary

The study purpose is to demonstrate safety and performance of bilateral implantation of LuxHighAdd intraocular lens compared with the LuxGood Monofocal lens.

Conditions

  • Cataract

Interventions

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.

Sponsors & Collaborators

  • Cutting Edge SAS

    lead INDUSTRY

Principal Investigators

  • Alain Saad, MD · Hôpital Fondation Adolphe de Rothschild

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-19
Primary Completion
2026-03-01
Completion
2026-07-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06446817 on ClinicalTrials.gov