Clinical trial Recruiting at 2 sites Interventional Ages 50 and up

Assessing the safety and performance of LuxBoost intraocular lenses for cataract patients

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

Run by Cutting Edge SAS · NCT06258707 · Data updated 2026-11-12

This study is testing if a new type of eye lens called LuxBoost can improve vision and is safe for people over 50 who are having cataract surgery.

More Aphakia trials

Quick facts

Study typeInterventional
Ages50 Years and up
SexAll
Enrollment58 (estimated)
SponsorCutting Edge SAS
Industry-sponsored
Locations2 sites (Montauban and 1 other locations)
StatusRecruiting
StartedOctober 14, 2024
Main results expectedDecember 15, 2027
Study endsJune 15, 2028
Registry record updatedAugust 18, 2026
Trial IDNCT06258707 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals aged 50 or older with bilateral cataracts who have not undergone previous refractive surgery.

Probably not a fit

Patients with pre-existing ocular pathologies or degenerative visual disorders may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical investigation aims to evaluate the safety and performance of bilateral implantation of LuxBoost intraocular lenses (IOLs) in patients with cataracts, comparing them to the LuxGood monofocal lens. The study involves participants aged 50 and over who are scheduled for posterior chamber IOL implantation. The LuxBoost IOL is a hydrophobic acrylic lens designed to enhance visual outcomes for patients with aphakia. Participants will undergo a series of examinations to assess the effectiveness and safety of the lens post-implantation.

Why it matters

Potential benefit: If successful, this study could provide patients with improved visual outcomes and safety following cataract surgery.

How similar studies have gone: Previous studies have shown promising results with similar intraocular lens technologies, indicating potential for success in this investigation.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Clinique Honore Cave
    Montauban, France
    Recruiting
  • West Ophta
    Rennes, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.