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A randomized controlled study on the prevention of myopia in school-age children using low intensity single wavelength red light as a new therapy

A randomized controlled study on the prevention of myopia in school-age children using low intensity single wavelength red light as a new therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070790
Enrollment
Unknown
Registered
2023-04-23
Start date
2023-04-20
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Interventions

Test group:Illuminate both eyes with low intensity red light (power 2 ± 0.5 mW
Maintain treatment for 12 months, then discontinue for 3 months
Control group:Behavioral intervention, myopia prevention education, observation for 15 months

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion age: 6-12 years old; 2. After systematic ophthalmic examination, the patient is in the preclinical stage of myopia: after cycloplegia, the equivalent spherical mirror of both eyes should be checked -0.50 D < SE =+0.50 D, and astigmatism should be less than 1.00 D; 3. The best corrected visual acuity for one eye is 1.0 or above; 4. Parents agree to be randomly divided and sign an informed consent form.

Exclusion criteria

Exclusion criteria: Subjects who meet any of the following criteria are not eligible for admission to this study. 1. Children who have used low concentration atropine eye drops (0.01% -0.5%) or high concentration atropine eye drops (1%) or corneal shaping lenses or multifocal/bifocal frame lenses for myopia control within the past three months; 2. Children with anisometropia (with a difference in diopter between two eyes greater than 1.50D in the spherical mirror), strabismus, and amblyopia; 3. Secondary myopia (such as those who have suffered from retinopathy in premature infants or other eye diseases during infancy and young children), or myopia combined with systemic syndrome (such as those with Marfan syndrome); 4. Individuals with a history of photosensitivity, autoimmune diseases, and other major systemic diseases; 5. Those with refractive medium opacity (such as corneal lesions, lens opacity, etc.); 6. Individuals with retinal, optic nerve, macular degeneration, or other congenital or hereditary inner eye diseases; 7. People with moderate to severe dry eye, corneal disease, cataract, vitreoretinal disease, infectious conjunctivitis, uveitis, optic nerve damage, congenital optic nerve dysplasia or other eye diseases; 8. Individuals with intellectual disabilities, hyperactivity, etc. who cannot cooperate with treatment and follow-up; 9. Other reasons that the researcher believes are not suitable for inclusion in the project.

Design outcomes

Primary

MeasureTime frame
Axial Length;

Secondary

MeasureTime frame
spherical equivalent;

Countries

China

Contacts

Public ContactZhang Zhihua

Shanghai General Hospital

drzhihuazhang@126.com+86 13817901235

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026