Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00383

2 Trial Registration Date

2013-12-17

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

5 Primary Sponsor

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

6 Secondary Sponsor

Nil

Function

Please specify

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

i Name

Ms. Joyce Kung

ii Address

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, 3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

iii Phone

3943 5813

iv Email

joycekung@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

Dr. Yam Cheuk Sing Jason

ii Address

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, 3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

iii Phone

39435892

iv Email

yamcheuksing@gmail.com

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Evaluation of different regimen and concentration of low dose topical atropine in retarding myopia progression

10 Public Title

Evaluation of different regimen and concentration of low dose topical atropine in retarding myopia progression

i Public Title in Chinese 研究名稱

不同劑量阿托品眼藥水在近視加深控制之研究

11 Short Title (Optional)

Low dose atropine for myopia progression study

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?

2013-11-19

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Myopia

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Atropine

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

Atropine eye drops 0.1%, 0.01%, 0.005%, and normal saline 0.9%

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

 Age 4 to 12
 Myopia : SE -1 to -10 D
 Astigmatism: < 2.5 D
 Anisometropia : < 2.0 D
 Myopia progression > 1 D for BE in one yr
 Informed parental consent

ii Exclusion Criteria

 Ophthalmic diseases other than refractive errors
 Previous use of treatment of atropine
 Allergy or intolerance to atropine
 Inability to attend regular follow up assessment

iii Age Minimum

4

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

Double-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

2014-01-02

21 Target Sample Size

520

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

-Change in spherical equivalent refraction (cycloplegic refraction)
-Change in axial length

24 Secondary Outcome

-Safety variable: Best corrected visual acuity, pupil size, intraocular pressure

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2021-07-07

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-13004032

28 Date of Registration in Primary Registry

2013-12-24

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2013-12-30