Clinical trial NCT06446817: Bicentric Clinical Investigation to Assess Safety and Performance of LuxHighAdd IOL
Official title: Multicentric Clinical Investigation to Determine Safety and Efficacy of a Hydrophobic Acrylic Multifocal Intraocular Lens
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cataract
Lead sponsor: Cutting Edge SAS
Sponsor class: INDUSTRY
First posted: 2024-06-06
Enrollment: 57
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

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

Primary outcomes:
measure: Distance Corrected Near Visual Acuity (DCNVA)
timeFrame: 4/6 months after surgery
measure: Best corrected distance visual acuity (BCDVA)
timeFrame: 4/6 months after surgery
Secondary outcomes:
measure: Uncorrected Distance Visual Acuity (UDVA)
timeFrame: 4/6 months after surgery
measure: Uncorrected Intermediate Visual Acuity (UIVA)
timeFrame: 4/6 months after surgery
measure: Uncorrected Near Visual Acuity (UNVA)
timeFrame: 4/6 months after surgery
measure: Distance Corrected Intermediate Visual Acuity (DCIVA)
timeFrame: 4/6 months after surgery
measure: Manifest Refraction
timeFrame: 4/6 months after surgery
measure: Defocus curve
timeFrame: 4/6 months after surgery
measure: Adverse events rates
timeFrame: 4/6 months after surgery
measure: Contrast Sensitivity
timeFrame: 4/6 months after surgery
measure: Halo and glare scores
timeFrame: 4/6 months after surgery
measure: Patient-reported outcomes: Quality of vision Questionnaire
timeFrame: 4/6 months after surgery
measure: Patient-reported outcomes: Spectacle independance Questionnaire
timeFrame: 4/6 months after surgery
measure: Patient-reported outcomes: open-ended question
timeFrame: 4/6 months after surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation Adolphe de Rothschild
city: Rennes
country: France
facility: WestOphta
Study officials:
affiliation: Hôpital Fondation Adolphe de Rothschild
name: Alain Saad, MD
role: PRINCIPAL_INVESTIGATOR
References: