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RECRUITINGINTERVENTIONAL

Bicentric Clinical Investigation to Assess Safety and Performance of LuxHighAdd IOL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

LuxHighAdd IOL

Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.

DEVICE

LuxGood IOL

Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.

Locations (2)

Hôpital Fondation Adolphe de Rothschild
Paris, France
WestOphta
Rennes, France