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A Study on Photobiomodulation Therapy for Improving Visual Development in Children with High Hyperopia

Safety and Efficacy of Photobiomodulation Therapy in Promoting Emmetropization in Children with High Hyperopia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120163
Enrollment
Unknown
Registered
2026-03-10
Start date
2026-03-10
Completion date
Unknown
Last updated
2026-03-16

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

Conditions

Hyperopia

Interventions

Trial Group:Wearing single-vision spectacle lenses + receiving PBM therapy (twice daily, 3 minutes each session, with at least 4 hours interval)
Control Group:Wearing single-vision spectacle lenses

Sponsors

Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1.Children aged 4 to 12 years, of either sex; 2. Cycloplegic refraction (after atropine-induced mydriasis) showing a refractive error of > +6.00 diopters (D) in both eyes, with astigmatism = 0.1 (decimal); 5. Ability to cooperate with visual acuity testing, cycloplegic refraction, ocular biometry, treatment procedures, and scheduled follow-up visits; 6. Written informed consent provided by the legal guardian prior to enrollment, with age-appropriate assent obtained from the child; children older than 8 years are required to sign a child-version informed consent form.

Exclusion criteria

Exclusion criteria: 1.Presence of organic ocular diseases, including corneal opacity, lens opacity or congenital cataract, retinal diseases, glaucoma or suspected elevated intraocular pressure, or severe ptosis affecting fixation; 2.Astigmatism > 2.50 D or large-angle manifest strabismus (corneal light reflex displaced beyond the pupillary margin); 3.History of ocular surgery or use of special ophthalmic medications; 4. Abnormal growth or development, such as endocrine disorders (e.g., short stature, precocious puberty), developmental or behavioral disorders that may interfere with cooperation; 5. Photosensitive epilepsy, a history of light-induced seizures, or any other safety concerns deemed by the investigator to make the participant unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Change in axial length (mm);

Secondary

MeasureTime frame
Change in refractive error (D);

Countries

China

Contacts

Public ContactLiu Hong

Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine

liuhong@scmc.com.cn+86 21 38626161

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026