Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL

Not Applicable

Recruiting

• Conditions: Aphakia
• Interventions: Device: LuxBoost IOL; Device: LuxGood IOL

• Registration Number: NCT06258707
• Lead Sponsor: Cutting Edge SAS

Brief 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.

Study Timeline

• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-02-12
• Study First Posted: 2024-02-14
• Status Verified: 2024-08
• Study Start: 2024-10-14
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2026-09-15
• Study Completion: 2026-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Subject aged 50 or over on the day of inclusion, presenting a
• bilateral cataract for which posterior chamber IOL implantation
• has been planned.
• Fit within the available IOL diopter range.
• Have had no previous refractive surgery.
• Regular corneal astigmatism < 1 dioptre by an automatic
• keratometer (regularity measured by topographer).
• Availability, willingness, and sufficient cognitive awareness to
• comply with examination procedures.
• Ability to attend all study follow-ups.
• Signed informed consent.

Exclusion Criteria

• Ocular surface disease potentially affecting study results
• Subjects suffering from diagnosed degenerative visual disorders
• Pre-existing ocular pathology
• Acute or chronic disease or illness that would increase risk or confound study results
• Axial lengths and keratometry such as the IOL spherical power is
• not in the range of 14 to 28 D
• Instability of keratometry or biometry measurements
• Amblyopia
• History of ocular trauma or any prior ocular surgery including refractive procedures
• Capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LuxBoost Group	LuxBoost IOL	the experimental group will receive the LuxBoost intraocular lens.
LuxGood group	LuxGood IOL	the control group will receive the LuxGood parent intraocular lens.

Primary Outcome Measures

Name	Time	Method
Best corrected distance visual acuity (CDVA)	4/6 months after surgery	To demonstrate the non-inferiority of LuxBoost IOL compared with the LuxGood monofocal control lens in terms of best corrected distance visual acuity (CDVA) by means of statistical significance.

Secondary Outcome Measures

Name	Time	Method
Uncorrected Distance Visual Acuity (UDVA), Uncorrected Intermediate Visual Acuity (UIVA), Distance Corrected Intermediate Visual Acuity (DCIVA), Uncorrected Near Visual Acuity (UNVA), Distance Corrected Near Visual Acuity (DCNVA)	4/6 months after surgery	Photopic visual acuity at far, intermediate and near distance in monocular and binocular with LuxBoost lens compared to LuxGood lens.
Defocus curve	4/6 months after surgery	Binocular defocus curve with the distance correction

Trial Locations

Locations (2)

Clinique Honore Cave; 🇫🇷 Montauban, France

West Optha; 🇫🇷 Rennes, France