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The safety of repeated low-intensity red light therapy for the treatment of myopia in children

The safety of repeated low-intensity red light therapy for the treatment of myopia in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075398
Enrollment
Unknown
Registered
2023-09-04
Start date
2023-10-01
Completion date
Unknown
Last updated
2023-09-11

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

Conditions

myopia

Interventions

intervention group:RLRL+defocus spectacle
control group:defocus spectacle

Sponsors

Tianjin medical university eye hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 12 Years

Inclusion criteria

Inclusion criteria: ? Age 8-12 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 -6.00D after mydriasis, with astigmatism<2.50D, 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
UCVA;

Secondary

MeasureTime frame
mfERG;color vision;OCT;axial length;spherical equivalent;self-reporting;

Countries

China

Contacts

Public ContactZhang Hongmei

Tianjin medical university eye hospital

zhm3958557@163.com+86 155 2257 8602

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026