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A randomized trial comparing patching versus acupuncture for amblyopia in 7 to <13 years old

A randomized trial comparing patching versus acupuncture for amblyopia in 7 to <13 years old

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10000792
Enrollment
Unknown
Registered
2010-02-17
Start date
2006-12-04
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Anisometropic amblyopia

Interventions

Two groups:Refractive correction plus acupuncture plus near activities: full time spectacle correction is prescribed to each of the subject. The subjects are guided to have at least 1 hour of near act
Two groups:Five acupoints are selected, including “Baihui” (GV20), “Taiyang” (EX-HN5), “Cuanzhu” (BL2), “Hegu” (LI4) and “Fuyang” (BL59). Disposable acupuncture needles are inserted 1-20 mm in depth d
Two groups:Refractive correction plus patching plus near activities: full time spectacle correction is prescribed to each of the subject. Two hours of daily patching of the better-seeing eye is prescr

Sponsors

Nil
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
7 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Aged 7 to less than 13 years 2. Interocular visual acuity difference of >=2 logMAR lines; 3. Anisometropia of >= 0.50 diopters (D) of spherical equivalent and/or a >= -1.50-D difference between the eyes in astigmatism; 4. Visual acuity in the amblyopic eye of 0.3 - 0.8 logMAR for moderate amblyopia and of 0.8-1.3 logMAR for severe amblyopia; 5. Visual acuity in the sound eye >= 0.1 logMAR; 6. Myopic SE <= -6.00 D in the amblyopic eye; 7. No measurable heterotropia in primary gaze at distance or near fixation with their spectacles or a documented history of strabismus; 8. No other ocular cause for reduced acuity and no other prior treatment for amblyopia except for spectacle use. Spectacles, if needed, worn for at least 16 weeks or visual acuity documented to be stable; 9. Informed parental consent.

Exclusion criteria

Exclusion criteria: 1. Patients with ocular diseases other than refractive error and amblyopia; 2. Systemic diseases that require chronic or regular intermittent medication (e.g. Down Syndrome, asthma, allergy, epilepsy and so on); 3. Allergy to cycloplegics; 4. Inability to attend for follow up assessment; 5. Inability to tolerate and cooperate in acupuncture procedure; 6. Myopia more than -6.0D SE in the amblyopic eye.

Design outcomes

Primary

MeasureTime frame
Best corrected visual acuity (BCVA) at each follow-up visit for both the amblyopic and sound eyes;

Secondary

MeasureTime frame
Refractive errors, stereoacuity, the time to attain the stable acuity and RNFLT and macular thickness measurements by OCT.;

Countries

China

Contacts

Public ContactProf. Dennis Shun Chiu Lam
dennislam_cu_res@cuhk.edu.hk+852 2762 3157

Outcome results

None listed

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