Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00038

2 Trial Registration Date

2005-09-07

i Registration Status

Prospective

3 Secondary IDs

nil

4 Source(s) of Funding

RGC grant

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Please specify

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

i Name

FAN Shu Ping Dorothy

ii Address

Department of Ophthalomology & Visual Sciences, The Chinese University of Hong Kong

iii Phone

27623168

iv Email

dorothyfan@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

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

i Name

FAN Shu Ping Dorothy

ii Address

Department of Ophthalomology & Visual Sciences, The Chinese University of Hong Kong

iii Phone

27623168

iv Email

dorothyfan@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Prevention of myopia development in kindergarten children by early correction of astigmatism

10 Public Title

Prevention of myopia development by early correction of astigmatism

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Myopic progression and astigmatism correction

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2005-02-01

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Eye Diseases

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

Spectacles correction

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

2 years

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

No spectacles correction

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

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Children aged 2 to 6 With mild astigmatism No othre eye diseases except for refractive error

ii Exclusion Criteria

Previous use of medication for prevention of myopic progression

iii Age Minimum

3

iv Age Maximum

12

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Open label

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

2006-01-01

21 Target Sample Size

200

22 Recruitment Status

Complete

23 Primary Outcome

Myopia development

24 Secondary Outcome

axial length growth

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-12-04

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000634

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2011-02-08