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Trial Detail

CUHK_CCT00383

2013-12-17

Prospective

Nil

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

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

Nil

Not Applicable

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

Low Concentration Atropine for Myopia Progression Study (LAMP)

Low Concentration Atropine for Myopia Progression Study (LAMP)

低濃度阿托品眼藥水對近視進展控制之研究

Low dose atropine for myopia progression study

Hong Kong

Yes

2013-11-19

Kowloon Central Cluster REC / Kowloon East Cluster REC

KC/KE-13-0182/FR-2

Myopia

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

Interventional

Randomized

Subjects will be assigned to 4 arms

Placebo

Double-blind

Parallel

3

2014-01-02

500

Complete

Efficacy:
- Myopic progression is measured by change in SER. Cycloplegic refraction is assessed by using autorefractometer
- Eyeball growth is measured by change in axial length. The measurement is by IOL master.

Confounding factors:
Age, parental histories of myopia and initial SER are potential confounding factors of myopic progression.

Safety:
- Questionnaire for self-reported visual function
- Best corrected visual acuity using ETDRS chart
- Intraocular pressures measured by applanation
- Pupil size in room light measured by pupillometer
- Ocular and systemic symptoms
- Ocular signs assessed by slit lamp biomicroscopy and binocular indirect ophthalmoscopy
- Heart rate & blood pressure

No

2021-07-07

ChiCTR-TRC-13004032

2013-12-24

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