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Effectiveness of Acupuncture Point Embedding Combined with Orthokeratology Lenses for Myopia in Children and Its Impact on the Ocular Surface

Effectiveness of Acupuncture Point Embedding Combined with Orthokeratology Lenses for Myopia in Children and Its Impact on the Ocular Surface

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000395
Enrollment
Unknown
Registered
2025-02-24
Start date
2025-03-01
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Children's Myopia and Ocular Surface Health

Interventions

Research Group (Ocular Surface Research Section):intradermal needle therapy + orthokeratology
Control group (ocular surface study portion):Orthokeratology
Research Group (Enhanced Efficacy Study Section):intradermal needle therapy + orthokeratology
Control group (enhanced efficacy study part):Orthokeratology

Sponsors

Eye & Ent Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Corneal Research Section (1) Trial wear of orthokeratology lenses is successful, i.e., subjects who will wear orthokeratology lenses regularly; (2) Age between 8-12 years old; (3) Refractive error after cycloplegia: -4.00 D to -0.50 D, astigmatism =1.50 D, anisometropia =1.50 D, corrected visual acuity =0.8, intraocular pressure between 10-21 mmHg; (4) Patients voluntarily join the trial with good compliance, and both the subject and guardian have signed the informed consent form. 2. Enhancement Study Section (1) Regular wear of orthokeratology lenses for more than 3 months; (2) Age between 8-12 years old; (3) Refractive error after cycloplegia: -4.00 D to -0.50 D, astigmatism =1.50 D, anisometropia =1.50 D, corrected visual acuity =0.8, intraocular pressure between 10-21 mmHg; (4) Voluntarily join the study with good compliance, and the guardian has signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Ocular Surface Research Section (1) Patients with other ocular diseases (cataracts, congenital retinal diseases, strabismus, amblyopia, etc.) or systemic diseases; (2) Patients with active ocular lesions or a history of ocular surgery; (3) Patients unable to cooperate with ocular examinations or treatments; (4) Patients with local acupoint skin damage or inflammation; (5) Patients who have worn orthokeratology lenses; (6) Patients who have used any myopia control methods within the past month; (7) Patients with adhesive or metal allergies. 2. Efficacy Enhancement Research Section (1) Patients with other ocular diseases (cataracts, congenital retinal diseases, strabismus, amblyopia, etc.) or systemic diseases; (2) Patients with active ocular lesions or a history of ocular surgery; (3) Patients unable to cooperate with ocular examinations or treatments; (4) Patients with local acupoint skin damage or inflammation; (5) Patients who have used any myopia control methods (excluding orthokeratology lenses) within the past month; (6) Patients with adhesive or metal allergies.

Design outcomes

Primary

MeasureTime frame
Ocular Surface Disease Index;Change in axial length of the eye;

Secondary

MeasureTime frame
Success time of orthokeratology lens wearing and removal;Non-invasive break-up time;Tear meniscus height;Red eye index;Corneal fluorescein staining;Hospital Anxietyand Depression Scale;Equivalent Sphere;corneal curvature;Anterior chamber depth;

Countries

China

Contacts

Public ContactXingtao Zhou

Eye & ENT Hospital of Fudan University

xingtaozhou@163.com+86 13816880725

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Mar 14, 2026