Controlling myopia progression in children using different light intensities
A Prospective Clinical Trial on Slow Myopia Progression With Two Different Irradiance Light at Baseline and Dynamic Changes at Follow-up
This study is testing if different strengths of red light therapy can help slow down worsening eyesight in children aged 6 to 12 who have myopia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | Beijing Airdoc Technology Co., Ltd. Industry-sponsored |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05881655 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of red light therapy in controlling myopia progression in children aged 6 to 12. A total of 75 participants will be divided into three groups, with two groups receiving different intensities of red light (0.6 mW and 1.2 mW) through specially designed spectacles, while a control group will wear similar spectacles without the light treatment. The study aims to assess changes in ocular parameters and refractive error over a 6-month period, with follow-ups at 3 months and 6 months to determine which light intensity is more effective in slowing myopia progression.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 to 12 with myopia ranging from -0.50 D to -5.00 D.
Not a fit: Patients with conditions such as photophobia, significant strabismus, or those currently using other myopia control devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive method to slow down myopia progression in children, potentially reducing the risk of severe vision problems later in life.
How similar studies have performed: While the use of light therapy for myopia control is a relatively novel approach, similar studies have shown promising results in managing myopia progression.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 6\~12 years old * Refractive Error of Myopia within -0.50 D\~-5.00 D, Anisometropia less or equal to 2.00D, The best corrected vision acuity is better or equal to 0.8 （decimal record). * Written consent formed with supervisions and children with 6 month follow-up. Exclusion Criteria: * Photophobia or allergy to any cycloplegic eyedrops (such as tropcaine, cyclopentolate). * Lesions in fundus or any part of eyeball with abnormal corrected vision such as keratoconus. * Strabisumus with angles large or equal to 5 prism dioper. * With other myopia control device such as atropine, Orthokeratology, Misight lens or other myopia control device.
Where this trial is running
Shanghai
- Shanghai Children Medical Center — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Hong Liu, MD, PHD — Shanghai Children's Medical Center
- Study coordinator: Sophia Wang, MD,PHD
- Email: hechao@airdoc.com
- Phone: +8618510386815
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.