Ireland
--:--IST
Recruiting Not applicable

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

NCT06446817 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-12-19
Last updated
2026-05-26

Condition(s) studied

Cataract

Investigational drug(s) / intervention(s)

LuxHighAdd IOLLuxGood IOL

LuxHighAdd IOL: Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.

LuxGood IOL: Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.

Study summary

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

Eligibility

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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.

Trial sites (3)

FacilityCityRegionStatus
Centre d'Ophtalmologie des Dr Rozot et associés Marseille France Recruiting
Clinique Honoré Cave Montauban France Recruiting
Hôpital Fondation Adolphe de Rothschild Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06446817 on ClinicalTrials.gov ↗ ← All trials in France