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

iRegistration 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

7Responsible 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

8Research 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

13Research 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

15Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Atropine

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, Group 4 will use 0.9% normal saline both eyes once daily

v Duration of the intervention

5 years

vi Frequency of the intervention

Once Daily

16Comparative Treatments

i Description/ name of comparative treatments

Normal saline(Placebo)

ii Dosage form of the comparative treatments

Eyedrop

iii Dosage of the comparative treatments

0.9%

iv Duration of the comparative treatments

5 years

v Frequency of the comparative treatments

Once Daily

17Key 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

19Study Design

i Randomization

Randomized

Please specify

Subjects will be assigned to 5 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

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last 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 2017-11-03