Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00258

2 Trial Registration Date

2010-02-18

iRegistration Status

Retrospective

3 Secondary IDs

Nil

4 Source(s) of Funding

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

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Please specify

7Responsible Contact Person (public contact person for patients interested in participating)

i Name

Zheng Chongren

ii Address

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

iii Phone

2762 3126

iv Email

iriszheng@cuhk.edu.hk

v Affiliation

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

vi Country

8Research Contact Person (person to contact for scientific inquiries)

i Name

Prof. Dennis Shun Chiu Lam

ii Address

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

iii Phone

2762 3157

iv Email

dennislam_cu_res@cuhk.edu.hk

v Affiliation

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

vi Country

9 Official Scientific Title of the Study

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

10 Public Title

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

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Acupuncture for anisometropic amblyopia

12 Countries of Recruitment

China

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2006-06-27

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Anisometropic amblyopia

15Intervention

i Types of intervention

Other

Please specify

Behavior, Device, Procedure

ii Description/ name of Intervention/article

Refractive correction plus acupuncture: full-time spectacle correction is prescribed to each subject. Acupuncture treatment is prescribed with 5 sessions per week. Five acupoints are selected, including “Baihui” (GV20), “Taiyang” (EX-HN5), “Cuanzhu” (BL2), “Hegu” (LI4) and “Fuyang” (BL59). For the two treatment groups, one group will receive acupuncture in the first 15 weeks and the other group will receive acupuncture during the second 15 weeks of the study. All subjects will be followed-up at 5 weeks intervals for the first 45 weeks and a finial visit at 60±1 weeks.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

60±1 weeks

vi Frequency of the intervention

16Comparative Treatments

i Description/ name of comparative treatments

Spectacle correction alone: spectacle correction alone will be prescribed to the subjects in one group during the first 15 weeks and then after the 30th week. For the other group, spectacle correction alone will be prescribed after acupuncture is finished by the end of 15 weeks. During the acupuncture phase, all subjects received spectacle correction combined with acupuncture. All subjects will be followed-up at 5 weeks intervals for the first 45 weeks and a finial visit at 60±1 weeks.

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1. Age 3 to <7 years;
2. Visual acuity in the amblyopic eye between 20/40 and 20/400 inclusive;
3. Visual acuity in the sound eye 20/40 or better and interocular acuity difference ≥ 2 logMAR lines;
4. Children with newly diagnosed amblyopia (Best corrected visual acuity of <20/40, or a difference of at least two lines on LogMAR acuity chart);
5. Anisometropia
 ≥ 0.5 D difference between eyes in spherical equivalent; and/or
 ≥ 1.5 D difference between eyes in astigmatism in any meridian
6. No prior amblyopia treatment (including spectacles);
7. Informed parental consent.

ii Exclusion Criteria

1. Patients with ocular diseases other than refractive error, strabismus (including microtropia) 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.

iii Age Minimum

3

iv Age Maximum

7

v Gender

Both Male and Female

18 Study Type

Interventional

19Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2006-12-04

21 Target Sample Size

100

22 Recruitment Status

Complete

23 Primary Outcome

Best spectacle-corrected visual acuity (BSCVA) in the amblyopic-eye at weeks 15 and 30.

24 Secondary Outcome

BSCVA in the amblyopic-eye in other visits other than the primary outcome visits; BSCVA in the sound eye at every visit; proportions of responder and resolution of amblyopia; other ocular investigative parameters whenever applicable.

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2011-03-21

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-10000791

28 Date of Registration in Primary Registry

2010-10-15

Back History

Trial Detail