Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LuxBoost IOL, LuxGood IOL.
- Who it may be relevant to
- Registry conditions: Aphakia. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Bicentric Clinical Investigation to Assess Safety and Performance of a Hydrophobic Acrylic Enhanced Monofocal Intraocular Lens.
Overview
The study purpose is to demonstrate safety and performance of bilateral implantation of LuxBoost intraocular lenses compared with the LuxGood Monofocal lens.
Detailed description
The study purpose is to demonstrate safety and performance after bilateral implantation of LuxBoost intraocular lenses.
The device under investigation is a hydrophobic acrylic monofocal intraocular lens (IOL) manufactured by the sponsor of this study.
Interventions
- Device LuxBoost IOL
Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens. - Device LuxGood IOL
Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
Primary outcome measures
- Best corrected distance visual acuity (CDVA) [Time frame: 4/6 months after surgery]
Secondary outcome measures (2)
- Uncorrected Distance Visual Acuity (UDVA), Uncorrected Intermediate Visual Acuity (UIVA), Distance Corrected Intermediate Visual Acuity (DCIVA), Uncorrected Near Visual Acuity (UNVA), Distance Corrected Near Visual Acuity (DCNVA) [Time frame: 4/6 months after surgery]
- Defocus curve [Time frame: 4/6 months after surgery]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 2 centers
- Clinique Honore Cave — Montauban
- West Ophta — Rennes
Identifiers
NCT: NCT06258707 · CE2302 · 2023-A02342-43