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

ConditionMyopia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorBeijing Tongren Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    Myopia correction, optic way

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Red lightExperimental treatment 1 intervention
Group B: controlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Axial length

Time frame
Baseline, 3-month, 6-month, 9-month, 12-month
2

Sphearical equivalent error

Time frame
Baseline, 3-month, 6-month, 9-month, 12-month

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: