Acupuncture for Amblyopia: A Randomized, Patient-Assessor Blinded, Controlled Pilot Clinical Trial

Korea Institute of Oriental Medicine0 个研究点目标入组 45 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

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•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

•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

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