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

Not Applicable

Please specify

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

i Name

Ms. Jennifer Tsoi

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 5869

iv Email

jennifertsoi@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

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

Hong Kong

9 Official Scientific Title of the Study

Chinese University Low dose Atropine for Myopia Progression Study (CU-LAMP)

10 Public Title

Chinese University Low dose Atropine for Myopia Progression Study (CU-LAMP)

i Public Title in Chinese 研究名稱

香港中文大學低濃度阿托品眼藥水對近視進展控制之研究

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

Kowloon Central Cluster REC / Kowloon East Cluster REC

Please specify

iv IRB/IEC approval reference number

KC/KE-13-0182/FR-2

14 Medical Condition Being Studied

Myopia

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Atropine.

There will be a washout period of one year for all Group 1-3 children after two years treatment. The myopia progression status will be assessed at the end of the washout period. If the progression is -0.5D or more during the washout period, the original treatment in the first two years will be reapplied to these children for two more years.

iii Dosage form of the intervention

Eyedrop

iv Dosage of the intervention

Group 1 will use 0.05% atropine both eyes once daily, Group 2 will use 0.025% atropine both eyes once daily, Group 3 will use 0.01% atropine both eyes once daily

v Duration of the intervention

2 years

vi Frequency of the intervention

Once Daily

16 Comparative Treatments

i Description/ name of comparative treatments

Group 4 will use 0.9% normal saline (placebo) both eyes once daily

ii Dosage form of the comparative treatments

Eyedrop

iii Dosage of the comparative treatments

0.9%

iv Duration of the comparative treatments

1 years, children in this group will switch to 0.05% atropine group, and randomized to treatment

v Frequency of the comparative treatments

Once Daily

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
 History of myopia progression > 0.5 D for Both eyes in one year
 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

Subjects will be assigned to 4 arms

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

3

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-01-02

21 Target Sample Size

500

22 Recruitment Status

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

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Trial History Detail on 2018-11-09