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Randomized, controlled, multicenter clinical study on the effectiveness of repetitive low intensity single wavelength red light combined with defocused frame mirrors in controlling low myopia in children and adolescents

Randomized, controlled, multicenter clinical study on the effectiveness of repetitive low intensity single wavelength red light combined with defocused frame mirrors in controlling low myopia in children and adolescents

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070931
Enrollment
Unknown
Registered
2023-04-26
Start date
2023-04-30
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:lluminate both eyes with low intensity red light (power 2 ± 0.5 mW
Wearing defocus frame mirrors during the day Maintenance treatment for 12 months
Control group:Wearing defocus frame mirrors during the day Maintenance treatment for 12 months

Sponsors

Shanghai Eye Disease Prevention and Control Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: ? Age 6-12 years old, regardless of gender; ? Any eye that meets the diagnosis of myopic refractive error and has a myopic equivalent spherical lens between -0.50D and -2.00D after mydriasis, with astigmatism<2.00D, binocular anisometropia<3.00D, and optimal corrected far vision of at least 1.0 and near vision of at least 1.0; ? Having normal thinking and language communication skills, able to actively cooperate with and treat according to requirements; ? No contraindication of atropine treatment such as acute ocular inflammation, dry eye, keratoconus, diabetes, etc; ? The guardian and the child have written informed consent.

Exclusion criteria

Exclusion criteria: History of photosensitivity, glaucoma, ciliary syndrome, high intraocular pressure, presence of lesions or injuries in the macula of the fundus; Corneal curvature examination, with an average K value of = 45 on the anterior surface of the cornea; Patients with systemic diseases such as heart, liver, kidney, and congenital hereditary myopia; Patients with chronic eye diseases such as concomitant eye injuries, oblique or surgical eyes, and atopic keratoconjunctivitis; Individuals who have previously had entropion and trichiasis, severe angular and conjunctival infections, and other eye diseases; Complaint of symptoms of vitreous opacity, B-ultrasound examination found vitreous opacity; Those with nervous system disease and allergy or contraindication to atropine or other therapeutic drugs; Patients with immune system and systemic diseases such as albinism, psoriasis, nephrotic syndrome, systemic lupus erythematosus, diabetes; Epilepsy, mental disorders, inability to communicate normally; Previously received other treatments to control the development of myopia, such as using anticholinergic drugs such as atropine within 3 months, or participated in other related research such as functional frame lenses and multifocal soft lenses; Other situations that have been determined by the researcher to be unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
Axial Length;

Secondary

MeasureTime frame
spherical equivalent;

Countries

China

Contacts

Public ContactXu Yan

Shanghai Eye Disease Prevention and Control Center

drxuyan_2004@163.com+86 18621080996

Outcome results

None listed

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