Prospective

Zheng Chongren

3/F Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong

2762 3126

iriszheng@cuhk.edu.hk

Department of Ophthalmology and Visual Sciences, the Chinese University of Hong Kong, Hong Kong, China

Prof. Dennis Shun Chiu Lam

3/F Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong

2762 3157

dennislam_cu_res@cuhk.edu.hk

Department of Ophthalmology and Visual Sciences, the Chinese University of Hong Kong, Hong Kong, China

Yes

2009-05-29

Other

Behavior / Device / Procedure

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 week. Five acupoints are selected, including “Baihui” (GV20), “Taiyang” (EX-HN5), “Cuanzhu” (BL2), “Hegu” (LI4) and “Fuyang” (BL59).
Children who meet the eligibility will be randomized into Group 1, Group 2 or group 3. Children in Group 1 will receive Treatment 1 (optical correction and acupuncture 1), Children in Group 2 will receive Treatment 2 (optical correction and acupuncture 2 (non-acupoint acupuncture)), whereas 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 of children in group 2 and 3 have remained stable for 10 weeks but not fulfill the criteria for resolution within the first 30 weeks, additional acupuncture will be prescribed.

60 weeks

Optical correction alone: Optical correction alone will be prescribed to the subjects in Group 3 for the first 30 weeks.

1. Aged 3 to <7;
2. Able to perform visual acuity using the ATS single-surround HOTV protocol;
3. Amblyopia associated with strabismus (comitant or incomitant), anisometropia, or both:
• 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 (and which in the judgment of the investigator is the cause of amblyopia)
• 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
• Criteria for combined mechanism amblyopia: Both of the following criteria must be met:
 -Criteria for strabismus are met (see above)
 -≥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.

4. Visual acuity, measured in each eye according to the procedures described later:
Has to meet the following criteria:
• Visual acuity in the amblyopic eye 20/40 to 20/400 inclusive;
• Visual acuity in the sound eye 20/40 or better
• 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.

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.

3

6

Both Male and Female

Randomized

Active

Single-blind

Parallel

No

Yes

Nil