Multicentric Clinical Investigation to Assess Safety and Performance of Lux HighAdd IOL
ConditionCataract
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorCutting Edge SAS
About this trial
The study purpose is to demonstrate safety and performance of bilateral implantation of LuxHighAdd intraocular lens compared with the LuxGood Monofocal lens.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- LuxHighAdd IOL
- LuxGood IOL
Treatment groups
57 Participants
are divided into 2 treatment groupsLocations
3Centre d'Ophtalmologie des Dr Rozot et associés13008, Marseille France
Clinique Honoré Cave82000, Montauban France
Hôpital Fondation Adolphe de Rothschild75019, Paris France
Sponsors and collaborators
Cutting Edge SAS
Lead sponsor
Source ClinicalTrials.gov