Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL

Bicentric Clinical Investigation to Assess Safety and Performance of a Hydrophobic Acrylic Enhanced Monofocal Intraocular Lens.

The study purpose is to demonstrate safety and performance of bilateral implantation of LuxBoost intraocular lenses compared with the LuxGood Monofocal lens.

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.

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