Informations générales (source: ClinicalTrials.gov)
Multicentric Clinical Investigation to Determine Safety and Efficacy of a Hydrophobic Acrylic Multifocal Intraocular Lens (HIGHADD)
Interventional
N/A
Cutting Edge SAS (Voir sur ClinicalTrials)
décembre 2024
juillet 2026
05 avril 2025
The study purpose is to demonstrate safety and performance of bilateral implantation of
LuxHighAdd intraocular lens compared with the LuxGood Monofocal lens.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FONDATION A. DE ROTHSCHILD | Alain Saad, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| WestOphta - 35000 - Rennes - France | Pierre-Emmanuel Arcade, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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