Amblyopia
Conditions
Interventions
1:Refractive correction plus acupuncture: full-time spectacle correction is prescribed to each subject. Acupuncture treatment 1 or 2 is given one time per day for 15 minutes each time, 5 times per wee
2:Children in Group 2 will receive Treatment 2 (optical correction and acupuncture 2 (non-acupoint acupuncture)
3:children in Group 3 will receive Treatment 3 (optical correction alone) for the first 30 weeks. Afterwards, children in three groups will be followed up for another 30 weeks. If the visual acuities
Sponsors
Hong Kong Eye Hospital
Eligibility
Sex/Gender
All
Age
3 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1. Aged 3 to =0.50 D difference between eyes in spherical equivalent; (2) 1.50 D difference between eyes in astigmatism in any meridian; 5. Criteria for combined mechanism amblyopia: Both of the following criteria must be met: (1) Criteria for strabismus are met (see above); (2) >=1.00 D difference between eyes in spherical equivalent or >=1.50 D difference between eyes in astigmatism in any meridian; (3) Note: the spherical equivalent requirement differs from that in the definition for refractive/anisometropic amblyopia. 4. Visual acuity, measured in each eye according to the procedures described later: Has to meet the following criteria: (1) Visual acuity in the amblyopic eye 20/40 to 20/400 inclusive; (2) Visual acuity in the sound eye 20/40 or better (3) Inter-eye acuity difference >=2 logMAR lines (i.e., amblyopic eye acuity at least 2 lines worse than sound eye acuity); 5. Children with newly diagnosed amblyopia (Best corrected visual acuity of <20/40, and a difference of at least two or more lines LogMAR visual acuity); 6. No prior amblyopia treatment (including spectacles); 7. No current vision therapy or orthoptics; 8. No ocular cause for reduced visual acuity; Nystagmus per se does not exclude the patient if the above visual acuity criteria are met. 9. Cycloplegic refraction and ocular examination within 2 months prior to enrolment; 10. No myopia more than a spherical equivalent of -6.00 D; 11. No prior intraocular or refractive surgery; 12. Parent understands protocol and, if child is eligible to enter randomized trial, parent is willing to accept randomized treatment; 13. Parent is willing to be contacted by DOVS or PWH staff; 14. 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 follow-up assessments; 5. Inability to tolerate and cooperate with the acupuncture procedure; 6. Myopia more than -6.0D SE in the amblyopic eye.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best-corrected visual acuity (BCVA) in the amblyopic eye at baseline and each follow-up visit.; | — |
Secondary
| Measure | Time frame |
|---|---|
| BCVA in the sound eye. The proportion of patients with resolved amblyopia and responder rate. Other parameters, e.g., stereoacuity, axial length, RNFL and macular thickness measurements, weight, height measurement, where appropriate.; | — |
Countries
China
Contacts
Public ContactProf. Dennis Shun Chiu Lam
Outcome results
None listed