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Clinical Investigation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 2025 to Jun 26, 2025
    v3
  2. Primary endpoints: 1 to 2v2 Show 6 more changesShow less
    • Primary completion date: Sep 2027 to Oct 2027
    • Start date: May 2025 to Jun 2025
    • Interventions: CABLE (1st year), HAL (2nd year) (Device), SVL (1st year), HAL with CABLE design (2nd year) (Device) to MCL (Device), MCL with passive red-light emission (Device), SVL (Device), SVL with passive red-light emission (Device)
    • Secondary endpoints: 1 to 2
    • Study description shortened, about 82 words
    • Study title revised
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this exploratory clinical trial is to evaluate the efficacy and safety of a test spectacle lens (standard single vision lens (SVL) during first year, and standard myopia control lens (MCL) in second year), designed with passive red-light emission, for the control of myopia progression in myopic children age 6 to 11 years old, both male and female, with no systemic or ocular anomalies. The main question it aims to answer is: Does the test spectacle lens designed with passive red-light emission provide significant myopia control effect to children? Researchers will compare the standard SVL designed with passive red-light emission to SVL (first year) and MCL designed with passive red-light emission to MCL (second year) to see if the test spectacle lens work to slow down myopia progression. Participants will: * Wear the study spectacles * Visit Essilor R\&D Centre for follow-up sessions
Trial Details
NCT Number NCT06850168
Lead Sponsor Essilor International
Conditions
(from sponsor)		 Myopia
Related terms Eye Diseases, Myopia, Refractive Errors
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov