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A prospective, randomized, parallel controlled, multicenter, optimal clinical trial to evaluate the safety and efficacy of foot point therapy boards for the treatment of myopia in children and adolescents

A prospective, randomized, parallel controlled, multicenter, optimal clinical trial to evaluate the safety and efficacy of foot point therapy boards for the treatment of myopia in children and adolescents

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084656
Enrollment
Unknown
Registered
2024-05-22
Start date
2024-06-03
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

myopia

Interventions

Experimental group:Use a foot healing board for treatment
Control group:Placebo control was performed using a non-therapeutic foot treatment board

Sponsors

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 15 Years

Inclusion criteria

Inclusion criteria: 1) Age 8-15 years old (including boundary values), gender is not limited; 2) Wear shoes between size 32 and 45 (including size 32 and 45); 3) Naked eye visual acuity < 1.0, -6.00D < equivalent spherical lens (SE) =-0.50D, the best corrected visual acuity =1.0; 4) According to the General Office of the National Health Commission (National Health Office Medical Letter [2018] No. 393) "Myopia Prevention and Treatment Guidelines" diagnosed as nearsighted; 5) No other organic lesions affecting vision in both eyes; 6) The subject and guardian can understand the purpose of this study and sign the informed consent, and the subject can cooperate with the treatment and related eye examination.

Exclusion criteria

Exclusion criteria: 1) Oblique amblyopia; 2) The dipsidedness exceeds ±5 circumferential degree (1 circumferential degree =1.75 prism degree); 3) Astigmatism greater than 2.50D; 4) Have had eye surgery (including strabismus surgery); 5) Congenital color vision disorder (color blindness, color weakness); 6) Any ocular, systemic or other disease that may be associated with myopia or affect refractive development, such as Marfan syndrome, retinopathy of prematurity, diabetes; 7) Any eye injury or corneal, conjunctival or eyelid disease (including keratoconus and herpetic keratitis), fundus lesions: 8) Wear bifocal glasses, progressive glasses, orthokeratology lenses, bifocal contact lenses or other functional lenses within 3 months; 9) Currently undergoing orthopaedic treatment or vision training; 10) Have used atropine eye medicine in the last 3 months; 11) photophobia or inability to open eyes normally; 12) any physiological structure, skin or other condition that may affect the wearing of the glasses; 13) Participated in other clinical trials 4 weeks before enrollment; 14) The subject has an acute or chronic medical condition (including other existing acute or chronic pain) or mental illness that may increase the risks associated with participation in the study or the use of the investigational product or that may affect the interpretation of the study results and which, in the judgment of the investigator or a medically qualified designee, makes the subject unfit for enrollment in the study.

Design outcomes

Primary

MeasureTime frame
Therapeutic effectiveness;Choroidal thickness;

Secondary

MeasureTime frame
Therapeutic effectiveness;Naked vision;Equivalent spherical mirror;Axial length;Blood vessel density in macular area;

Countries

China

Contacts

Public ContactXinquan Liu

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine

drliuxinquan@hotmail.com+86 189 1776 3077

Outcome results

None listed

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