RecruitingNot ApplicableNCT06258707

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.

Sponsor

Cutting Edge SAS

Enrollment

58 participants

Start Date

Oct 14, 2024

Study Type

INTERVENTIONAL

Conditions

Aphakia

Summary

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

Eligibility

Min Age: 50 Years

Inclusion Criteria11

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 Criteria10

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

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