Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL
Recruiting now · Not applicable
Conditions studied: Aphakia
In brief
The study purpose is to demonstrate safety and performance of bilateral implantation of LuxBoost intraocular lenses compared with the LuxGood Monofocal lens.
Key facts
- Study ID
- NCT06258707
- Run by
- Cutting Edge SAS
- People needed
- 58
- Starts
- 2024-10-14
- Expected to finish
- 2027-06-15
- Last updated by the study team
- 2026-02-12
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Clinique Honore Cave — Montauban, France (enrolling)
- West Ophta — Rennes, France (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.