Amblyopia
Conditions
Interventions
Three groups:Refractive correction plus acupuncture plus near activities: full time spectacle correction is prescribed to each subject. The subjects are guided to have at least 1 hour of near activiti
Three groups:Acupuncture treatment is given one time per day for 15 minutes each time, 5 days per week. Five acupoints are selected, including “Baihui” (GV20), “Taiyang” (EX-HN5), “Cuanzhu” (BL2), “He
Group 1:Optical correction with spectacles plus acupoint acupuncture plus daily patching of the sound eye for 2-6 hours per day depends on the severity of amblyopia plus near activities for at least 1
Group 2:optical correction with spectacles plus non-acupoint acupuncture plus daily patching of the sound eye for 2-6 hours per day (depends on the severity of amblyopia) plus near activities for at l
Group 3:optical correction with spectacles plus patching of the sound eye for 2 hours per day plus near activities for 1 hour while patching
Sponsors
Hong Kong Eye Hospital
Eligibility
Sex/Gender
All
Age
7 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Age: 7 to 0.50 D difference between eyes in spherical equivalent; (2) >1.50 D difference between eyes in astigmatism in any meridian; c. 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. Note: the spherical equivalent requirement differs from that in the definition for refractive/anisometropic amblyopia. 3. Visual acuity, measured in each eye without cycloplegia within 7 days prior to randomization using the E-ETDRS protocol on Electronic Visual Acuity Tester, as follows: (1) Visual acuity in the amblyopic eye between 19 to 71 letters inclusive (20/40 to 20/400 inclusive); (2) Visual acuity in the sound eye >=79 letters (20/25 or better); (3) Interocular acuity difference >=10 letters (i.e., amblyopic eye acuity at least 2 lines worse than sound eye acuity). 4. No amblyopia treatment (other than spectacles) in the last 6 months (any treatment more than 6 months prior to enrollment is acceptable); 5. No current vision therapy or orthoptics; 6. Ocular examination within 6 months prior to enrollment showing no ocular cause for reduced visual acuity; 7. Cycloplegic refraction within 6 months prior to enrollment; 8. Myopia no more than -6.0 D spherical equivalent in either eye; 9. Spectacle correction for measurement of enrollment visual acuity must meet the following criteria and be based on a cycloplegic refraction that is no more than 6 months old (refractive error must be corrected with spectacles and not contact lenses): a. Requirements for spectacle correction: (1) For patients meeting criteria for strabismus (see 2.a above); (2) Hypermetropia if corrected must not be undercorrected by more than +1.50 D spherical equivalent, and the reduction in plus sphere must be symmetric in the two eyes. Otherwise, spectacle correction is at investigator discretion; (3) For patients meeting criteria for anisometropia or combined-mechanism (see #2. b, c above); (4) Spherical equivalent must be within 0.50 D of fully correcting the anisometropia; (5) Hypermetropia must not be undercorrected by more than +1.50 D spherical equivalent, and reduction in plus must be symmetric in the two eyes; (6) Cylinder power in both eyes must be within 0.50 D of fully correcting the astigmatism; (7) Cylinder axis in the spectacle lenses in both eyes must be within 6 degrees of the axis of the cycloplegic refraction when cylinder power is > 1.00 D. b. Spectacles meeting above criteria must be worn either: (1) for at least 16 weeks immediately prior to enrollment; or (2) until visual acuity in amblyopic eye is stable (defined as two consecutive visual acuity measurements by the same testing method at least 4 weeks apart with no improvement of one logMAR line or more); (3) A
Exclusion criteria
Exclusion criteria: 1. Patients with ocular diseases other than refractive error, strabismus (including microtropia) 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 assessment; 5. Inability to tolerate and cooperate with 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 amblyop; | — |
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