Assessing the safety and performance of LuxBoost intraocular lenses for cataract patients
Bicentric Clinical Investigation to Assess Safety and Performance of a Hydrophobic Acrylic Enhanced Monofocal Intraocular Lens.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Cutting Edge SAS Industry-sponsored |
| Locations | 2 sites (Montauban and 1 other locations) |
| Trial ID | NCT06258707 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 or older with bilateral cataracts who have not undergone previous refractive surgery.
Not a fit: Patients with pre-existing ocular pathologies or degenerative visual disorders may not benefit from this study.
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 performed: Previous studies have shown promising results with similar intraocular lens technologies, indicating potential for success in this investigation.
Eligibility criteria
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 this trial is running
Montauban and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.