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Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL

Study acronym: LuxBoost
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 15, 2026 → Dec 15, 2027
See other at-risk trials from Cutting Edge SAS

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 15, 2026 to Dec 15, 2027
    • Study completion pushed from Jun 15, 2027 to Jun 15, 2028
    v5
  2. Primary completion date: Sep 15, 2026 to Dec 15, 2026
    • Study completion date: Dec 15, 2026 to Jun 15, 2027
    • Study sites revised (2)
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 15, 2024 to Oct 14, 2024
    • Site details revised at 2 of 2 sites
    v3
  4. Primary completion date: Aug 15, 2025 to Sep 15, 2026
    • Start date: Apr 15, 2024 to Sep 15, 2024
    • Study sites: 0 to 2
    • Study completion date: Jan 15, 2026 to Dec 15, 2026
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The study purpose is to demonstrate safety and performance of bilateral implantation of LuxBoost intraocular lenses compared with the LuxGood Monofocal lens.
Trial Details
NCT Number NCT06258707
Lead Sponsor Cutting Edge SAS
Conditions
(from sponsor)		 Aphakia
Related terms Aphakia
Enrollment 58 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov