Actively Recruiting
Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL
Led by Cutting Edge SAS · Updated on 2026-02-12
58
Participants Needed
2
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study purpose is to demonstrate safety and performance of bilateral implantation of LuxBoost intraocular lenses compared with the LuxGood Monofocal lens.
CONDITIONS
Official Title
Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Clinique Honore Cave
Montauban, France, 82000
Actively Recruiting
2
West Ophta
Rennes, France, 35000
Actively Recruiting
Research Team
I
Ilham XHAARD
CONTACT
L
Line BETTINELLI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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