Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00467

2 Trial Registration Date

2015-08-06

i Registration Status

Prospective

3 Secondary IDs

KC/KE-15-0089/FR-3

4 Source(s) of Funding

Department of Ophthalmology and Visual Sciences, CUHK

5 Primary Sponsor

Department of Ophthalmology and Visual Sciences, CUHK

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Miss MAK Hoi Ching Haley

ii Address

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

iii Phone

39435833

iv Email

haleymak@cuhk.edu.hk

v Affiliation

Department of Ophthalmology and Visual Sciences, 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

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

iii Phone

39435833

iv Email

yamcheuksing@gmail.com

v Affiliation

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

vi Country

Hong Kong

9 Official Scientific Title of the Study

Prevention of Myopia onset using ultra-low dose atropine. (PRE-MYO Study)

10 Public Title

Prevention of Myopia onset using ultra-low dose atropine. (PRE-MYO Study)

i Public Title in Chinese 研究名稱

超低濃度阿托品眼藥水在近視發病預防之研究

11 Short Title (Optional)

ultra-low dose atropine for myopia prevention 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?

2015-07-24

iii Full Name of IRB/IEC

Kowloon Central Cluster REC / Kowloon East Cluster REC

Please specify

iv IRB/IEC approval reference number

KC/KE-15-0089/FR-3

14 Medical Condition Being Studied

atropine, myopia

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

– Treatment Group: 0.01% atropine
– Treatment Group: 0.05% atropine

iii Dosage form of the intervention

Eye drops

iv Dosage of the intervention

One drop

v Duration of the intervention

2 years

vi Frequency of the intervention

Once a day

16 Comparative Treatments

i Description/ name of comparative treatments

– Placebo Group: lubricant eye drops

ii Dosage form of the comparative treatments

Eye drops

iii Dosage of the comparative treatments

One drop

iv Duration of the comparative treatments

2 years

v Frequency of the comparative treatments

Once a day

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

- Age 4 to 9
- Myopia : SE > -1.0D and < +1.0 D
- Astigmatism: < 1 D
- Informed parental consent

ii Exclusion Criteria

- Ophthalmic diseases
Refractive errors: SE < -1.0D or > +1.0 D
- 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

9

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Randomized eligible children into 3 groups

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

2015-07-01

21 Target Sample Size

300

22 Recruitment Status

Recruiting

23 Primary Outcome

Proportion of onset of myopia and proportion of fast myopia progressor in each group.

24 Secondary Outcome

Myopic progression is measured by change in spherical equivalent refraction (SER). Cycloplegic refraction is assessed by using an auto-refractometer. Eyeball growth is measured by change in axial length, using the IOL master.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2022-06-14

27 Primary Registry and Trial Identifying Number

ChiCTR-IPR-15006883

28 Date of Registration in Primary Registry

2015-08-06

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Trial History Detail on 2018-07-03