Multicentric Clinical Investigation to Assess Safety and Performance of Lux HighAdd IOL (HIGHADD)

Multicentric Clinical Investigation to Determine Safety and Efficacy of a Hydrophobic Acrylic Multifocal Intraocular Lens

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

Study Overview

• Status: Recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: LuxGood IOL; Device: LuxHighAdd IOL

Detailed Description

The study purpose is to demonstrate safety and performance after bilateral implantation of LuxHighAdd intraocular lenses.

The device under investigation is a hydrophobic acrylic multifocal intraocular lens (IOL) manufactured by the sponsor of this study.

• Study Type: Interventional
• Enrollment (Estimated): 57
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Line Bettinelli, OD; Phone Number: 0619530701; Email: line.bettinelli@bausch.com
• Study Contact Backup: Name: Christophe Cesses; Phone Number: 0786991458; Email: christophe.cesses@bausch.com

Study Locations

• France
  • Marseille, France, 13008
    • Recruiting
    • Centre d'Ophtalmologie des Dr Rozot et associés
    • Contact: Dr Rozot, MD; Phone Number: +334 91 22 24 29
    • Principal Investigator: Pascal ROZOT, MD
  • Montauban, France, 82000
    • Recruiting
    • Clinique Honore Cave
    • Contact: Cloé Sanchez; Phone Number: +33563030304; Email: cloe.sanchez@clinique-honore-cave.com
    • Principal Investigator: Vincent GUALINO, MD
  • Paris, France, 75019
    • Recruiting
    • Hôpital Fondation Adolphe de Rothschild
    • Principal Investigator: Alain Saad, MD
    • Contact: Alain Saad, MD

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, qualified for bilateral implantation
• No ocular comorbidity possibly affecting the study results
• Fit within the available IOL diopter range
• Have had no previous refractive surgery
• Regular corneal astigmatism ≤1.0 dioptres
• Clear intraocular media other than cataract
• 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
• Pre-existing ocular pathology or history of pathology potentially affecting the study results
• Acute or chronic disease or illness that would increase risk or confound study results
• Subjects who may be reasonably expected to require a secondary surgical intervention at any time during the investigation (other than YAG capsulotomy)
• Axial lengths and keratometry such as the IOL spherical power is not in the range of 16 to 26 D
• Instability of keratometry or biometry measurements
• Traumatic cataract
• 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
• Pupil abnormalities
• Systemic or ocular medication that could modify pupil dynamics
• Expected complicated surgery or complicated surgery
• Concurrent participation in another drug or device investigation

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LuxHighAdd; The experimental group will recieve the LuxHighAdd intraocular lens bilaterally.	Device: LuxHighAdd IOL; Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
Active Comparator: LuxGood group; The control group will recieve the LuxGood intraocular lens bilaterally.	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
Distance Corrected Near Visual Acuity (DCNVA)	To demonstrate the difference in monocular DCNVA between the High Add lens and the LuxGood monofocal lens by means of statistical significance.	4/6 months after surgery
Best corrected distance visual acuity (BCDVA)	To demonstrate the non-inferiority of the Lux High Add lens compared with the monofocal control LuxGood lens in terms of BCDVA by means of statistical significance.	4/6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Defocus curve	Binocular defocus curve with the distance correction	4/6 months after surgery
Uncorrected Distance Visual Acuity (UDVA)	Uncorrected photopic visual acuity at far in monocular and binocular with LuxHighAdd lens compared to LuxGood lens.	4/6 months after surgery
Uncorrected Intermediate Visual Acuity (UIVA)	Uncorrected photopic visual acuity at intermediate distance in monocular and binocular with LuxHighAdd lens compared to LuxGood lens.	4/6 months after surgery
Uncorrected Near Visual Acuity (UNVA)	Uncorrected photopic visual acuity at near distance in monocular and binocular with LuxHighAdd lens compared to LuxGood lens.	4/6 months after surgery
Distance Corrected Intermediate Visual Acuity (DCIVA)	Photopic visual acuity at intermediate distance in monocular and binocular with best distance correction with LuxHighAdd lens compared to LuxGood lens.	4/6 months after surgery
Manifest Refraction	Manifest subjective refraction	4/6 months after surgery
Adverse events rates	Adverse events rates	4/6 months after surgery
Contrast Sensitivity	Contrast Sensitivity in binocular conditions with distance correction	4/6 months after surgery
Halo and glare scores	Halos and glare assessed with a simulator	4/6 months after surgery
Patient-reported outcomes: Quality of vision Questionnaire	Assessment of quality of vision (CatQuest-9SF)	4/6 months after surgery
Patient-reported outcomes: Spectacle independance Questionnaire	Assessment of spectacle independence (PRSIQ questionnaire )	4/6 months after surgery
Patient-reported outcomes: open-ended question	Frequency and proportion of eyes with ocular and visual symptoms (non-directed complaints) using an open-ended question	4/6 months after surgery

Collaborators and Investigators

• Sponsor: Cutting Edge SAS
• Investigators: Principal Investigator: Alain Saad, MD, Hôpital Fondation Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 23, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CE2301; 2023-A01904-41 (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