Actively Recruiting
A Real-world Study to Evaluate the Efficacy of 650nm Low-intensity Single-wavelength Red Light in the Prevention and Control of Myopia in Children and Adolescents
Led by Beijing Tongren Hospital · Updated on 2024-10-08
2000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of low-level 650nm red-light irradiation in controlling and preventing myopia in children and adolescents aged 7 to 18 years. This real-world study includes children who are already myopic as well as those with normal vision or mild farsightedness. The study is conducted across multiple hospitals and aims to gather data over three years with follow-ups at six months, one year, and two years. The intervention involves the use of a headworn device that delivers 650nm low-intensity red light to the eyes. This device has been approved for safety and is used by children in everyday settings, not just within the study. The study observes children who are already receiving this red-light treatment, without providing additional interventions, and excludes participants using certain medications like atropine due to safety concerns. Participants will be monitored through regular assessments including measurements of eye axial length and spherical equivalent error at baseline and follow-up visits. Additional eye health measures such as choroid thickness, keratometry, lens thickness, anterior chamber depth, and corneal thickness will also be tracked. The study collects data on these outcomes to understand the red-light treatment's role in myopia control over the study period.
CONDITIONS
Brief Title
A Real-world Study of 650nm Low-intensity Single-wavelength Red Light for Children and Adolescents
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 7 to 18 years
- Cycloplegic spherical equivalent error (SER) of +0.5D or less in both eyes
- Astigmatism of 2.5D or less (\u22642.5D)
- Willing to participate and sign informed consent form
You will not qualify if you...
- Eye diseases such as strabismus, amblyopia, ocular tumors, glaucoma, macular disease, keratitis, eye trauma, uveitis
- Systemic diseases including epilepsy, tumors, heart disease, asthma, immune diseases, infectious diseases
- Mental diseases
- Use of similar interventions within the past year
- Allergy to cycloplegic agents or red light
- Red light intervention deemed unsuitable by researchers
- Current or recent (less than 1 month) use of atropine or similar drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants who undergo routine care with the 650 nm low-level red-light device are observed to evaluate changes in eye measurements over time.
Visits at baseline, 6 months, 1 year, and 2 years
Trial Site Locations
Total: 1 location
1
Red light
Beijing, Beijing Municipality, China, 100005
Actively Recruiting
Research Team
K
Kai Cao
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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