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Trial History Detail on 2014-01-29

CUHK_CCT00261

2010-05-12

Prospective

Nil

Yan Ai Eye Foundation, DOVS, 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

Safety and efficacy of using acupuncture as an adjunct to optical correction for amblyopia in children aged 3 to <7:A randomized controlled trial

Safety and efficacy of using acupuncture as an adjunct to optical correction for amblyopia in children aged 3 to <7

Acupuncture for amblyopia in children aged 3 to <7

Hong Kong, China

Yes

2009-05-29

Amblyopia

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

Interventional

Randomized

Active

Single-blind

Parallel

2010-05-15

150

Complete

Best-corrected visual acuity (BCVA) in the amblyopic eye at baseline and each follow-up visit.

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.

No

2014-01-29

ChiCTR-TRC-10000903

2010-06-24


Yes

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