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Trial Detail

CUHK_CCT00248

2010-02-17

Retrospective

Nil

Mr. Lai Seung Hung and Mrs. Lai Chan Pui Ngong Fund, Hong Kong, China

Nil

Nil

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

A randomized trial comparing patching versus acupuncture for amblyopia in 7 to <13 years old

A randomized trial comparing patching versus acupuncture for amblyopia in 7 to <13 years old

Acupuncture versus patching for amblyopia

China

Yes

2006-06-27

Anisometropic amblyopia

Other

Behavior, Device, Procedure

Refractive correction plus acupuncture plus near activities: full time spectacle correction is prescribed to each of the subject. The subjects are guided to have at least 1 hour of near activities every day. Acupuncture treatment is prescribed with 5 sessions per week. Needling is performed by a certified acupuncturist in China. Five acupoints are selected, including “Baihui” (GV20), “Taiyang” (EX-HN5), “Cuanzhu” (BL2), “Hegu” (LI4) and “Fuyang” (BL59). Disposable acupuncture needles are inserted 1-20 mm in depth depending on the acupuncture sites, manually manipulated by rotation methods to produce a characteristic sensation known as “De Qi”, and left in place for 15 minutes. The subjects are followed up at 5-, 10-, 15-, 17-, 25-, 40- and 52-week.

1 year

Refractive correction plus patching plus near activities: full time spectacle correction is prescribed to each of the subject. Two hours of daily patching of the better-seeing eye is prescribed to each subject. The subjects are guided to have at least 1 hour of near activities while patching. The subjects are followed up at 5-, 10-, 15-, 17-, 25-, 40- and 52-week. And the duration of the study is 1 year.

1. Aged 7 to less than 13 years
2. Interocular visual acuity difference of ≥2 logMAR lines;
3. Anisometropia of ≥0.50 diopters (D) of spherical equivalent and/or a ≥-1.50-D difference between the eyes in astigmatism;
4. Visual acuity in the amblyopic eye of 0.3 - 0.8 logMAR for moderate amblyopia and of 0.8-1.3 logMAR for severe amblyopia;
5. Visual acuity in the sound eye ≥0.1 logMAR;
6. Myopic SE ≤ -6.00 D in the amblyopic eye;
7. No measurable heterotropia in primary gaze at distance or near fixation with their spectacles or a documented history of strabismus;
8. No other ocular cause for reduced acuity and no other prior treatment for amblyopia except for spectacle use. Spectacles, if needed, worn for at least 16 weeks or visual acuity documented to be stable;
9. 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 for follow up assessment;
5. Inability to tolerate and cooperate in acupuncture procedure;
6. Myopia more than -6.0D SE in the amblyopic eye.

7

12

Both Male and Female

Interventional

Randomized

Active

Single-blind

Parallel

2006-12-04

160

Complete

Best corrected visual acuity (BCVA) at each follow-up visit for both the amblyopic and sound eyes

Refractive errors, stereoacuity, the time to attain the stable acuity and RNFLT and macular thickness measurements by OCT.

No

2011-03-21

ChiCTR-TRC-10000792

2010-05-04

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