Multicentric Clinical Investigation to Assess Safety and Performance of Lux HighAdd IOL
Condition(s) studied
Investigational drug(s) / intervention(s)
LuxHighAdd IOL: Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
LuxGood IOL: Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
Study summary
The study purpose is to demonstrate safety and performance of bilateral implantation of LuxHighAdd intraocular lens compared with the LuxGood Monofocal lens.
Eligibility
Primary outcome measure(s)
- Distance Corrected Near Visual Acuity (DCNVA) — 4/6 months after surgery
To demonstrate the difference in monocular DCNVA between the High Add lens and the LuxGood monofocal lens by means of statistical significance. - Best corrected distance visual acuity (BCDVA) — 4/6 months after surgery
To demonstrate the non-inferiority of the Lux High Add lens compared with the monofocal control LuxGood lens in terms of BCDVA by means of statistical significance.
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Centre d'Ophtalmologie des Dr Rozot et associés | Marseille | France | Recruiting |
| Clinique Honoré Cave | Montauban | France | Recruiting |
| Hôpital Fondation Adolphe de Rothschild | Paris | France | Recruiting |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06446817 on ClinicalTrials.gov ↗ ← All trials in France