Actively Recruiting
Bicentric Clinical Investigation to Assess Safety and Performance of LuxHighAdd IOL
Led by Cutting Edge SAS · Updated on 2025-02-12
57
Participants Needed
2
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study purpose is to demonstrate safety and performance of bilateral implantation of LuxHighAdd intraocular lens compared with the LuxGood Monofocal lens.
CONDITIONS
Official Title
Bicentric Clinical Investigation to Assess Safety and Performance of LuxHighAdd IOL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Hôpital Fondation Adolphe de Rothschild
Paris, France, 75019
Actively Recruiting
2
WestOphta
Rennes, France, 35000
Actively Recruiting
Research Team
L
Line Bettinelli, OD
CONTACT
C
Christophe Cesses
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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