Using low-level red light therapy to control myopia in children
Efficacy of Repeated Low-level Red-light Therapy in Myopia Control: a Single Arm Controlled Trial
This study is testing if low-level red light therapy can help control myopia in children aged 8-13 by comparing it to regular glasses over a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 8 Years to 13 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05606237 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of low-level red light therapy for controlling myopia in children aged 8-13 from diverse ethnic backgrounds. Participants will be randomly assigned to either receive the therapy twice daily or wear single vision spectacles only. The study will measure changes in axial elongation and visual acuity over a 12-month period, with assessments at multiple intervals. The goal is to confirm the efficacy of this innovative treatment approach across different populations.
Who should consider this trial
Good fit: Ideal candidates are myopic children aged 8-13 years from Hispanic, African, or Caucasian backgrounds with specific refractive criteria.
Not a fit: Patients with strabismus, significant ocular abnormalities, or those who do not comply with treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly reduce the progression of myopia in children, potentially preventing severe vision impairment later in life.
How similar studies have performed: Previous studies have shown promising results for low-level red light therapy in myopia control, particularly in Chinese populations, making this approach both innovative and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Provision of consent 2. Non-Chinese Ethnicity 3. Age: ≥8 and ≤13 years at enrollment 4. Myopia: Spherical equivalent refractions (SERs) under cycloplegia: -1.00 to -5.00 diopters (D) 4\) Astigmatism of 2.50 D or less 5) Anisometropia of 1.50 D or less 6) Corrected monocular logMAR visual acuity (VA): 1.0 or better 7) Consent to participate in random allocation of grouping 8) Fluent in English 9) Willing and able to participate in all required activities of the study6) Corrected monocular logMAR visual acuity (VA): 1.0 or better Exclusion Criteria: 1. Strabismus and binocular vision abnormalities in either eye 2. Ocular abnormalities in either eye or other systemic abnormalities that affect participate in all required activities of the study. 3. Other reasons, including but not limited to severe physical and cognitive disability, that the physician may consider inappropriate for enrollment 4. Noncompliance with treatment 5. Children whose parents do not sign informed consent
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Tiffany Chen, MD — University of California, San Francisco
- Study coordinator: Tiffany Chen, MD
- Email: Tiffany.A.Chen@ucsf.edu
- Phone: 4155143503
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.