None listed
Conditions
Interventions
Medical Device : A study that compares treatment efficacy of acupuncture plus patching VS. sham acupuncture plus patching VS. patching alone in the treatment of amblyopia.
Treatment regimen: 1-2 times
Sponsors
Korea Institute of Oriental Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 3 to <13 years 2. Amblyopia associated with strabismus (comitant or incomitant), anisometropia, or both 2-1 Criteria for strabismus: At least one of the following criteria must be met: - Heterotropia at distance and/or near fixation on examination (with or without spectacles) - History of strabismus surgery (or botulinum) - Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia) 2-2 Criteria for anisometropia: At least one of the following criteria must be met: - = 0.50 D difference between eyes in spherical equivalent - = 1.50 D difference between eyes in astigmatism in any meridian 2-3 Criteria for combined mechanism amblyopia: Both of the above criteria (strabismus and anisometropia) must be met 3. Visual acuity measured in each eye using age-appropriate best-corrected visual acuity testing as follows: - Visual acuity in the amblyopic eye between 20/32 and 20/400 inclusive - Visual acuity in the sound eye 20/40 or better - Interocular acuity difference = 2 logMAR lines 4. Spectacles must be worn for at least 16 weeks prior to enrollment and 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) 5. No amblyopia treatment (other than spectacles) 6. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Myopia more than -6.0D(SE) in either eye 2. Presence of an ocular cause for reduced visual acuity 3. Systemic disease that require chronic or regular intermittent medication 4. Prior intraocular or refractive surgery 5. Down syndrome 6. Known allergy to cycloplegic drugs or Known skin reactions to patch or bandage adhesives 7. Known hypersensitivity reaction to acupuncture treatment or inability to cooperate with acupuncture procedure 8. Those who are not willing to comply with this study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best-corrected visual acuity | — |
Secondary
| Measure | Time frame |
|---|---|
| Simultaneous prism and cover test;Stereoacuity (Titmus fly test, Randot preschool test);Compliance;Adverse events | — |
Countries
Korea, Republic of
Contacts
Public ContactJoo-Hee Kim
Korea Institute of Oriental Medicine
Outcome results
None listed