Multicentric Clinical Investigation to Assess Safety and Performance of Lux HighAdd IOL

Multicentric Clinical Investigation to Determine Safety and Efficacy of a Hydrophobic Acrylic Multifocal Intraocular Lens

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

The study purpose is to demonstrate safety and performance after bilateral implantation of LuxHighAdd intraocular lenses.

The device under investigation is a hydrophobic acrylic multifocal 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, qualified for bilateral implantation
• No ocular comorbidity possibly affecting the study results
• Fit within the available IOL diopter range
• Have had no previous refractive surgery
• Regular corneal astigmatism ≤1.0 dioptres
• Clear intraocular media other than cataract
• 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
• Pre-existing ocular pathology or history of pathology potentially affecting the study results
• Acute or chronic disease or illness that would increase risk or confound study results
• Subjects who may be reasonably expected to require a secondary surgical intervention at any time during the investigation (other than YAG capsulotomy)
• Axial lengths and keratometry such as the IOL spherical power is not in the range of 16 to 26 D
• Instability of keratometry or biometry measurements
• Traumatic cataract
• 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
• Pupil abnormalities
• Systemic or ocular medication that could modify pupil dynamics
• Expected complicated surgery or complicated surgery
• Concurrent participation in another drug or device investigation