Prospective

Ms. Jennifer Tsoi

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

3943 5818

jennifertsoi@cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong

Dr. Yam Cheuk Sing Jason

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, 4/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

39435892

yamcheuksing@cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong

低濃度阿托品眼藥水對近視進展控制之研究

Yes

2013-11-19

Kowloon Central Cluster REC / Kowloon East Cluster REC

KC/KE-13-0182/FR-2

Drug

Group 1: 0.05% atropine both eyes once daily; Group 2: 0.025% atropine both eyes once daily; Group 3: 0.01% atropine both eyes once daily

Phase 1 (first year), Children in the group 4 will use 0.9% normal saline only for 1 year.

Phase 2 (second year), After one year, children in this group will switch to 0.05% atropine daily treatment group Group 1, 2 and 3 of atropine treatment will be continued for one year. The myopia progression status will be assessed at the end of this period.

Phase 3 (third year), Three groups 0.05%, 0.025%, and 0.01% atropine, each was further randomized half to atropine-continued group (according to their original concentrations 0.05%, 0.025%, 0.01%), and half to washout group.. 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.

Phase 4 (fourth and fifth year), All drops will be switched to 0.05% atropine eye drops, accordingly to the following two treatment regimens: 1) Atropine-continued group; and 2) PRN treatment group.
Atropine-continued group: All subjects from the atropine-continued group 0.05%, 0.025%, and 0.01% who had completed the 3-years follow up in Phase 3 will be recruited into atropine-continued group. 0.05% atropine eye drops daily will be administered to both eyes till end of year 5, regardless of the myopia progression rate during the previous year.

PRN group: All subjects from the washout group 0.05%, 0.025%, and 0.01% who had completed the 3-years follow up in Phase 3 will be recruited into the PRN group. Protocol for restart treatment: atropine 0.05% will be restarted if myopic SE progressed 0.5D or more in either eye in the past one-year period, either during the washout period, or during the follow up of year 4 and year 5. Duration for treatment: atropine 0.05% will be used for at least one year. If myopia progresses less than 0.5D during the one-year treatment period, atropine drops will be stopped. Subjects will be continued for follow up at 6-months interval till end of year 5. If myopia progresses 0.5D or more, treatment will be continued for one more year or till end of year 5.

Eyedrop

Group 1: 0.05% atropine both eyes once daily; Group 2: 0.025% atropine both eyes once daily; Group 3: 0.01% atropine both eyes once daily

4-5 years

Once Daily

Group 4 will use 0.9% normal saline (placebo) both eyes once daily (to be switched to Group 1 after one year)

Eyedrop

0.9%

1 years, children in this group will then switch to 0.05% atropine daily treatment group

Once Daily

- 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

- 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

12

Both Male and Female

Randomized

Subjects will be assigned to 4 arms

Placebo

Double-blind

Parallel

3

No