Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL

Cutting Edge

Status: Enrolling

Conditions: Aphakia

Treatments: Device: LuxBoost IOL; Device: LuxGood IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT06258707

2023-A02342-43 (Registry Identifier)

CE2302

Details and patient eligibility

About

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

Full 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.

Enrollment: 58 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

LuxBoost Group

Experimental group

Description:

the experimental group will receive the LuxBoost intraocular lens.

Treatment:

Device: LuxBoost IOL

LuxGood group

Active Comparator group

Description:

the control group will receive the LuxGood parent intraocular lens.

Treatment:

Device: LuxGood IOL