Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL (LuxBoost)

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

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

Study Overview

• Status: Recruiting
• Conditions: Aphakia
• Intervention / Treatment: Device: LuxBoost IOL; Device: LuxGood IOL

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 Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ilham XHAARD; Phone Number: +33 620 050 651; Email: ilham.xhaard@cutting-edge.fr
• Study Contact Backup: Name: Line BETTINELLI; Phone Number: +33 619 530 701; Email: line.bettinelli@cutting-edge.fr

Study Locations

• France
  • Montauban, France, 82000
    • Recruiting
    • Clinique Honoré Cave
    • Principal Investigator: Vincent GUALINO, Dr
  • Rennes, France, 35000
    • Recruiting
    • West Ophta
    • Principal Investigator: Pierre-Emmanuel ARCADE, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LuxBoost Group; the experimental group will receive the LuxBoost intraocular lens.	Device: LuxBoost IOL; Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
Active Comparator: LuxGood group; the control group will receive the LuxGood parent intraocular lens.	Device: LuxGood IOL; Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best corrected distance visual acuity (CDVA)	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.	4/6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Photopic visual acuity at far, intermediate and near distance in monocular and binocular with LuxBoost lens compared to LuxGood lens.	4/6 months after surgery
Defocus curve	Binocular defocus curve with the distance correction	4/6 months after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported outcomes	Patient satisfaction using Catquest-9SF questionnaire : To assess if difficulties in daily life occur due to impaired sight. This questionnaire is a 9-item Rasch-scaled instrument to assess subjective perception of visual impairment after surgery [Lundström et al, 2009]. The acceptable values are > 3.00 for differentiation between low, medium, and high abilities. Rasch analysis is commonly reported as the mean of square residual (MNSQ) and z-standardized score (ZSTD).	at preoperative visit and 4/6 months after surgery

Collaborators and Investigators

• Sponsor: Cutting Edge SAS
• Investigators: Principal Investigator: Vincent GUALINO, Clinique Honoré Cave 82000 Montauban; Study Director: Christophe CESSES, Cutting Edge S.A.S (Sponsor)

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2024
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): June 15, 2027

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Enhanced monofocal IOL
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Aphakia
• Other Study ID Numbers: CE2302; 2023-A02342-43 (Registry Identifier: French BRC Identification number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No