Bicentric Clinical Investigation to Assess Safety and Performance of LuxHighAdd IOL

Not Applicable

Recruiting

• Conditions: Cataract
• Interventions: Device: LuxHighAdd IOL; Device: LuxGood IOL

• Registration Number: NCT06446817
• Lead Sponsor: Cutting Edge SAS

Brief Summary

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

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 Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-23
• Study First Submitted QC: 2024-06-05
• Study First Posted: 2024-06-06
• Study Start: 2024-12-19
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2026-03-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 57

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LuxHighAdd	LuxHighAdd IOL	The experimental group will recieve the LuxHighAdd intraocular lens bilaterally.
LuxGood group	LuxGood IOL	The control group will recieve the LuxGood intraocular lens bilaterally.

Primary Outcome Measures

Name	Time	Method
Distance Corrected Near Visual Acuity (DCNVA)	4/6 months after surgery	To demonstrate the difference in monocular DCNVA between the High Add lens and the LuxGood monofocal lens by means of statistical significance.
Best corrected distance visual acuity (BCDVA)	4/6 months after surgery	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Hôpital Fondation Adolphe de Rothschild; 🇫🇷 Paris, France

WestOphta; 🇫🇷 Rennes, France