Bicentric Clinical Investigation to Assess Safety and Performance of LuxHighAdd IOL

Exclusion Criteria14

• 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