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Safety and effectiveness of 650nm red light for myopia prevention and control in children

Safety and effectiveness of 650nm red light for myopia prevention and control in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062028
Enrollment
Unknown
Registered
2022-07-19
Start date
2022-04-05
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

Myopia

Interventions

Myopia experimental group :red light(7-12 years old children with myopia,SE:-0.50~-5.75D)
Pre-Myopia experimental group :red light(7-12 years old children with premyopia, SE:=+0.75,>-0.50D)
Adult experimental group:red light(18-35 years old, SE:-8.00D~+0.50D)
High myopia experimental group :red light(7-12 years old children with high myopia, SE:>-6.00D)
Myopia control group :single-vision spectacles(7-12 years old children with myopia,SE:-0.50~-5.75D)
Premyopia control group :N/A (7-12 years old children with premyopia, SE:=+0.75,>-0.50D)
High-myopia control group :single-vision spectacles(7-12 years old children with myopia,SE:-0.50~-5.75D)
Adult control group :N/A, myopic subjects would be provided with single-vision spectaclest(18-35 years old, SE:-8.00D~+0.50D)

Sponsors

Tianjin Key Laboratory of Retinal Functions and Diseases, Tianjin Branch of National Clinical Research Center for Ocular Disease, Eye Institute and School of Optometry, Tianjin Medical University Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. Ages 7 to 12 years, with written consent from the guardian mandatory. Gender is not restricted. 2. Children clinically diagnosed with high myopia (both eyes having a spherical equivalent refractive error of -6.00D or more and a cylindrical refractive error -0.50D after cycloplegic refraction). 5. Ages 18 to 35 years. Gender is not restricted. Both eyes should have a spherical equivalent refractive error between -8.00D and +0.50D after cycloplegic refraction.

Exclusion criteria

Exclusion criteria: 1. Have participated in any myopia control clinical research trial within the past 3 months. Previously used or are currently using special designed myopia control devices such as orthokeratology lenses, multifocal contact lenses, progressive addition lenses, or atropine medications. 2. Children with strabismus or amblyopia. 3. Suffering from congenital eye disorders such as congenital cataract or congenital retinal diseases. 4. Secondary myopia (e.g., due to retinopathy of prematurity or other ocular diseases in infancy) or myopia associated with systemic syndromes (e.g., Marfan syndrome). 5. Those who have undergone intraocular surgeries such as cataract extraction or intraocular lens implantation. 6. Those with refractive media opacities such as corneal diseases or lens opacity. 7. Abnormal intraocular pressure (intraocular pressure 21 mmHg or a binocular intraocular pressure difference >= 5 mmHg). 8. Patients with retinal fundus lesions or other intraocular disorders. 9. Patients with optic nerve damage or congenital optic nerve dysfunctions. 10. Only one eye meeting the inclusion criteria. 11. Unable to undergo regular ophthalmic examinations (or the guardian of a minor unable to accompany the minor regularly for ophthalmic examinations). 12. Other reasons deemed inappropriate for inclusion in the project by the investigator.

Design outcomes

Primary

MeasureTime frame
Axial Length;

Secondary

MeasureTime frame
spherical equivalent refraction;choroidal thickness;retinal thickness;Color vision;Pupil diameter;Eye surface analysis;

Countries

China

Contacts

Public ContactWei Ruihua

Tianjin Key Laboratory of Retinal Functions and Diseases, Tianjin Branch of National Clinical Research Center for Ocular Disease, Eye Institute and School of Optometry, Tianjin Medical University Eye Hospital

rwei@tmu.edu.cn+86 139 2068 5016

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026