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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 50 Years and up |
| Sex | All |
| Enrollment | 58 (estimated) |
| Sponsor | Cutting Edge SAS Industry-sponsored |
| Locations | 2 sites (Montauban and 1 other locations) |
| Status | Recruiting |
| Started | October 14, 2024 |
| Main results expected | December 15, 2027 |
| Study ends | June 15, 2028 |
| Registry record updated | August 18, 2026 |
| Trial ID | NCT06258707 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
- Principal investigator: Vincent GUALINO — Clinique Honoré Cave 82000 Montauban
- Study coordinator: Ilham XHAARD
- Email: ilham.xhaard@cutting-edge.fr
- Phone: 620 050 651
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparison of a new trifocal IOL with PanOptix Pro IOL in cataract surgery
This study tests whether the investigational trifocal IOL LPYWT0 works as well as the PanOptix Pro trifocal IOL in people with cataracts undergoing cataract surgery in both eyes.
-
Clareon TruPlus IOLs in Bilateral Cataract Surgery
This study tests Clareon TruPlus Monofocal IOLs to see how safe they are and how well they perform for people with both eyes affected by cataracts.
-
Visual adaptation and quality of life after different IOL implantation options
This study follows adults who have cataracts and receive bilateral multifocal or mixed IOLs to see how their vision and daily life improve over 6 months.
-
Comparing two surgical methods for fixing intraocular lenses without capsular support
This study is testing two different surgical methods to see which one works better for fixing eye lenses in patients who don't have the usual support from the eye's capsule.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.