Light therapy to slow down myopia in children

Clinical Study of Low Lever Red Light Therapy With 650nm to Control Myopia Progression in Children

This study tests if low-level red light therapy can help slow down worsening eyesight in children aged 6 to 16 with myopia.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 83 (estimated)
• Ages: 6 Years to 16 Years
• Sex: All
• Sponsor: Beijing Airdoc Technology Co., Ltd. (industry)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05761379 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of low-level red light therapy (LLLT) in controlling the progression of myopia in children aged 6 to 16 years. It compares two different types of photobiomodulation therapy against a control group over a one-month period. The therapy uses 650-nm red light to stimulate eye tissue safely, aiming to reduce myopia progression without harming surrounding tissues. The study also evaluates the safety and efficacy of these therapies in a pediatric population.

Who should consider this trial

Good fit: Ideal candidates are children aged 6 to 16 years with myopia ranging from -0.50D to -6.00D who have not undergone any myopia control measures in the past four weeks.

Not a fit: Patients with significant ocular or systemic diseases that could affect visual function or myopia progression will not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a non-invasive method to slow myopia progression in children, potentially reducing the risk of severe vision problems later in life.

How similar studies have performed: Previous studies have reported long-term efficacy of LLLT in slowing myopia progression, suggesting that this approach has shown promise.

Eligibility criteria

Inclusion Criteria:

1. Grade 1 to grade 9 and age 6 to 16 years (including 6 and 16 years), Sex is not limited;
2. Equivalent sphere (SER): -0.50D \~ -6.00D (including-0.50 and-6.00D);
3. Best corrected vision in one eye under glasses correction: 0.1 log MAR;
4. No strabismus: no more than 15 prism constant dominance strabismus after far and near cover tests;
5. No myopia control measures within the previous 4 weeks: such as orthokeratology lens, gradient lens, double light lens, eye drops for myopia control (such as atropine), myopia defocus glasses, red light for myopia control, other specially designed myopia light treatment instruments or contact lenses for special design to control myopia (such as Misight);

Exclusion Criteria:

1. Any ocular(including constant dominant strabismus with more than 15 prisms) and systemic diseases or abnormalities can significantly affect visual function or promote the progression of myopia;
2. Other interventions for myopia control before 4 weeks before enrollment, For example, orthoplastic lens, gradient lens, dual-light lens, eye drops for myopia control (atropine), myopia defocus glasses, red light therapy devices for myopia control, other specially designed comprehensive treatment devices, myopia, amblyopia, or specially designed contact lenses (such as Misight), etc.
3. Subject participated in other clinical trials within 4 weeks before the enrollment;
4. The investigator for safety reasons or the interests of the patient, Other circumstances in which the patient should not participate in this trial, If suffering from serious heart, liver and kidney disease. -

Where this trial is running

Shanghai, Shanghai

• Eye & ENT hospital of Fudan university — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Jenny Qiu, M.D.

Conditions: Myopia, Progressive