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Novel Lenses for Myopia Progression Trial

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment target: estimated 300 to confirmed 342v4
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v3
  3. Study title shortened, about 1 wordv2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a multi-center , prospective, randomised, longitudinal study to evaluate rate of myopia progression with novel lenses compared to Single-Vision spectacles. A total of 342 children will be recruited where 57 participants each are randomised to wear one of 5 test spectacle lens designs or a single vision lens (control) for 12 months. At the end of 12 months, those randomised to single vision lenses will be transferred to one of the test lenses and all the groups continued for another 12 months. Myopia progression during the second year with test lenses will be compared to historical or published controls.
Trial Details
NCT Number NCT06563700
Lead Sponsor Shanghai Eye Disease Prevention and Treatment Center
Conditions
(from sponsor)		 Myopia, Progressive
Related terms Myopia, Degenerative
Enrollment 342 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov