Assessing the safety and performance of a new intraocular lens for cataract surgery

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

This study is testing a new type of lens for cataract surgery to see if it improves vision better than a standard lens for people aged 50 and older.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 57 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Cutting Edge SAS (Industry-sponsored)
• Locations: 2 sites (Paris and 1 other locations)
• Trial ID: NCT06446817 on ClinicalTrials.gov

What this trial studies

This clinical investigation aims to evaluate the safety and performance of the LuxHighAdd intraocular lens (IOL) when implanted bilaterally in patients with cataracts. Participants will be compared to those receiving the LuxGood monofocal lens to determine the effectiveness of the new multifocal lens. The study will involve patients aged 50 and over who meet specific eligibility criteria, ensuring a controlled environment for accurate results. The primary focus is on the outcomes related to vision improvement and safety post-implantation.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 50 or older with bilateral cataracts who have not undergone previous refractive surgery.

Not a fit: Patients with significant ocular comorbidities or those requiring secondary surgical interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with improved vision outcomes following cataract surgery through the use of a new multifocal lens.

How similar studies have performed: Other studies have shown promising results with multifocal intraocular lenses, indicating potential success for this approach.

Eligibility criteria

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

Where this trial is running

Paris and 1 other locations

• Hôpital Fondation Adolphe de Rothschild — Paris, France (Recruiting)
• WestOphta — Rennes, France (Recruiting)

Study contacts

• Principal investigator: Alain Saad, MD — Hôpital Fondation Adolphe de Rothschild
• Study coordinator: Line Bettinelli, OD

Conditions Cataract