Bicentric Clinical Investigation to Assess Safety and Performance of LuxHighAdd IOL (HIGHADD)

Cutting Edge

Status: Enrolling

Conditions: Cataract

Treatments: Device: LuxHighAdd IOL; Device: LuxGood IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT06446817

CE2301

2023-A01904-41 (Registry Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 57 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, 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

LuxHighAdd

Experimental group

Description:

The experimental group will recieve the LuxHighAdd intraocular lens bilaterally.

Treatment:

Device: LuxHighAdd IOL

LuxGood group

Active Comparator group

Description:

The control group will recieve the LuxGood intraocular lens bilaterally.

Treatment:

Device: LuxGood IOL