Multicentric Clinical Investigation to Assess Safety and Performance of Lux HighAdd IOL
Recruiting now · Not applicable
Conditions studied: Cataract
In brief
The study purpose is to demonstrate safety and performance of bilateral implantation of LuxHighAdd intraocular lens compared with the LuxGood Monofocal lens.
Key facts
- Study ID
- NCT06446817
- Run by
- Cutting Edge SAS
- People needed
- 57
- Starts
- 2024-12-19
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-05-26
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Centre d'Ophtalmologie des Dr Rozot et associés — Marseille, France (enrolling)
- Clinique Honoré Cave — Montauban, France (enrolling)
- Hôpital Fondation Adolphe de Rothschild — Paris, France (enrolling)
Full record on ClinicalTrials.gov
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