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Recruiting Not applicable

Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL

NCT06258707 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-10-14
Last updated
2026-08-18

Condition(s) studied

Aphakia

Investigational drug(s) / intervention(s)

LuxBoost IOLLuxGood IOL

LuxBoost 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 LuxBoost intraocular lenses 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 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

Primary outcome measure(s)

  • 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.

Trial sites (2)

FacilityCityRegionStatus
Clinique Honore Cave Montauban France Recruiting
West Ophta Rennes 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 NCT06258707 on ClinicalTrials.gov ↗ ← All trials in France