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Clinical Study to Evaluate Clinical Outcomes of LuxSmart IOL as Compared With LuxGood IOL

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 12, 2025 (before its estimated April 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 238 to confirmed 251
    • Primary and study completion dates: Oct 2024 to Apr 2025
    • Site details revised at 8 of 8 sites
    v3
  2. Site details revised at 2 of 8 sitesv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is a multicentric, prospective, randomised, controlled, post-market clinical follow up (PMCF) study to investigate safety, visual outcomes and contrast sensitivity after bilateral implantation of either LuxSmart IOLs (study group) or LuxGood IOLs (control group).
Trial Details
NCT Number NCT06105190
Lead Sponsor Cutting Edge SAS
Collaborators: targomedGmbH
Conditions
(from sponsor)		 Cataract, Lens Opacities
Related terms Cataract
Enrollment 251 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov