Development of Bioluminescent Myopia Prevention and Control Instrument and Evaluation of Its Effect on Myopia

Sponsor
Beijing Tongren Hospital
Study ID
NCT07208617
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Myopia

Eligibility Criteria

Sex
ALL
Age
6 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • RED-light device using LED light source — DEVICE
    The light source type of red light is LED light source.
  • Control — DEVICE
    Fake light, with a light source power that is one-tenth of that of real LED light

Study Details

Based on the Tongren Myopia and Amblyopia Therapeutic Apparatus (a 650nm low-level red-light device) developed by the research team in the previous phase, the device was modified by replacing the light source with LED light. Subsequently, a population study was conducted to evaluate its efficacy and safety in myopia prevention and control.

Key Dates

First listed
Oct 6, 2025
Start date
Feb 12, 2026
Status verified
Sep 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
206 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LED red-light
  • Sham Comparator: control
    Fake light, with a light source power that is one-tenth of that of real LED light

Primary Outcome Measure

Axial length [ Time Frame: Baseline and 6-month follow-up ]

Central Contacts

Related Studies