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Trial History Detail on 2018-11-09

CUHK_CCT00467

2015-08-06

Prospective

KC/KE-15-0089/FR-3

Department of Ophthalmology and Visual Sciences, CUHK

Department of Ophthalmology and Visual Sciences, CUHK

N/A

Not Applicable

Ms Jennifer Tsoi

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

39435818

jennifertsoi@cuhk.edu.hk

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

Hong Kong

Dr. YAM Cheuk Sing Jason

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

39435833

yamcheuksing@gmail.com

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

Hong Kong

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

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

超低濃度阿托品眼藥水在近視發病預防之研究

ultra-low dose atropine for myopia prevention study

Hong Kong

Yes

2015-07-24

Kowloon Central Cluster REC / Kowloon East Cluster REC

KC/KE-15-0089/FR-3

atropine, myopia

Drug

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

Eye drops

One drop

2 years

Once a day

– Placebo Group: lubricant eye drops

Eye drops

One drop

2 years

Once a day

- Age 4 to 9
- SE :0~ +1.0 D
- Astigmatism: < 2 D
- Informed parental consent

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

4

9

Both Male and Female

Interventional

Randomized

Randomized eligible children into 3 groups

Placebo

Double-blind

Parallel

3

2015-07-01

300

Recruiting

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

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.

No

2022-06-14

ChiCTR-IPR-15006883

2015-08-06

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