Evaluation of the Efficacy of Red Light in Adult Patients With High and Extreme Myopia

Sponsor
Beijing Tongren Hospital
Study ID
NCT07412678
Status
Not Yet Recruiting

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Conditions

  • Myopia

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Red light — DEVICE
    Subjects receive low-intensity single-wavelength red light therapy using the Tongren Myopia and Amblyopia Therapeutic Apparatus , administered twice daily for 3 minutes per session with an interval of at least 4 hours, combined with single-vision frame glasses.
  • Single vision spectacle lenses — OTHER
    Myopia correction, optic way

Study Details

This study, led by Jie ying from the Ophthalmology Department of Beijing Tongren Hospital Affiliated to Capital Medical University, is a researcher-initiated clinical trial (IIT) designed to evaluate the therapeutic efficacy of low-intensity red light therapy in adult patients with high myopia (spherical equivalent ≤ -6.00D) and extreme myopia (spherical equivalent ≤ -10.00D). With the escalating global prevalence of high and extreme myopia-especially in East Asia including China-and pathological myopia becoming a leading cause of irreversible blindness in Chinese adults, red light therapy has shown promising effects in slowing myopia progression in children but lacks clinical evidence for adult populations, which constitutes the core rationale for this research.

Key Dates

First listed
Feb 17, 2026
Start date
Feb 12, 2026
Status verified
Feb 2026
Primary completion
Mar 11, 2027
Completion
Mar 11, 2027

Study Design

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

Arms

  • Experimental: Red light
  • Placebo Comparator: control

Primary Outcome Measure

Axial length [ Time Frame: Baseline, 3-month, 6-month, 9-month, 12-month ]

Central Contacts

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