Combining red light therapy and special glasses to control myopia in children
Myopia Control Combined PBM With Myopic Defocus Lens in Children: Double-blind RCT for 6 Month
This study is testing whether red light therapy or special glasses can help slow down worsening eyesight in children aged 6 to 13 who have myopia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 304 (estimated) |
| Ages | 6 Years to 13 Years |
| Sex | All |
| Sponsor | Beijing Airdoc Technology Co., Ltd. Industry-sponsored |
| Locations | 1 site (Xuzhou, Jiangsu) |
| Trial ID | NCT05756959 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of two methods for controlling progressive myopia in children aged 6 to 13 years. Participants will be randomly assigned to receive either low-level red light therapy or peripheral defocus spectacles, with a control group receiving single vision spectacles. The study is designed as a prospective, double-blind, randomized trial lasting six months. The aim is to assess how these interventions impact the progression of myopia in young patients.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 13 years with myopia ranging from -0.50D to -5.50D and no other myopia control interventions in the last three months.
Not a fit: Patients with significant ocular diseases, systemic conditions, or those currently using other myopia control methods may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new approach to effectively manage and slow the progression of myopia in children.
How similar studies have performed: While the combination of these specific interventions is novel, similar approaches in myopia control have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed consent by the supervision of the children * 6\~13 years old (including both the 6 and 13) * SE range: -0.50\~-5.50D * Astigmatism \<=2.00D * BCVA \>=0.8 * Anisometropia \<=1.50D * Confirmed to no use of other myopia control intervention Exclusion Criteria: * Ocular lesions to effect vision or diseases (such as cataract, glaucoma, marcular pathology, cornea lesions, uveitis, retina detachment, congential opitc abnormal and etc.) * Halo, glare, toutic, ADHD, psoriasis * Systom disease: immune disease, central nerve system, Down syndrome, asthma, severe cardiopulmonary abnormal, severe liver and renal dysfunction. * Squint, ocular lesion or acute imflammation. * Other myopia control interventions within recent 3 month such as atropine, device, orthokeratology, multi-focus soft lens, multi-function spectacles.
Where this trial is running
Xuzhou, Jiangsu
- the first people's hospital of Xuzhou — Xuzhou, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Ying Li, MD, PHD
- Email: 834582241@qq.com
- Phone: +8615162130727
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.