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| ID | Type | Description | Link |
|---|---|---|---|
| P0041308 | Other Identifier | The Hong Kong Polytechnic University |
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| Name | Class |
|---|---|
| The University of Hong Kong | OTHER |
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The purpose of the study is to investigate the combination effect of optical defocus and low dose atropine on myopia control in schoolchildren.
This study is a two-arm randomised controlled trial with a 18-month duration. Participants will be healthy Hong Kong Chinese schoolchildren with low to moderate myopia. The aim is to determine the combination effect of optical defocus and low dose atropine on myopia control in schoolchildren. Optical defocus will be delivered by Defocus Incorporated Multiple Segments (DIMS) spectacle lenses.
A total of 112 Hong Kong Chinese children aged 7 to 12 years (56 in each group) will be recruited and randomly allocated into two groups. One group will receive low dose atropine (0.01%) plus DIMS spectacles (ATD Group); another one will receive low dose atropine (0.01%) plus single vision spectacles (AT Group).
They must have no prior or current myopia control treatment, have no ocular or systemic diseases/abnormalities that affect visual function, refractive development or spectacle lens wear, and no previous intraocular or corneal surgery. They must not have allergy to atropine.
Their cycloplegic refraction and axial length will be monitored every six months for 18 months. The changes in refractive errors and axial length between groups will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose atropine plus DIMS | Experimental | This group will receive 0.01% atropine (twice per day: 1 drop in the morning and 1 drop at night before bedtime) and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses |
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| Low dose atropine | Experimental | This group will receive 0.01% atropine (twice per day: 1 drop in the morning and 1 drop at night before bedtime) and single vision spectacle lenses |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Defocus Incorporated Multiple Segments lenses | Device | Defocus Incorporated Multiple Segments lenses that provide optical defocus for myopia control will be given to this group of participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in cycloplegic refraction | Changes in cycloplegic refraction in spherical equivalent (Dioptres) over 18 months from baseline will be measured. | Baseline, 6th month, 12th month and 18th month |
| Changes in axial length | Changes in axial length (mm) over 18 months from baseline will be measured. | Baseline, 6th month, 12th month and 18th month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Ka Man Chun, PhD | The Hong Kong Polytechnic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Myopia Research, The Hong Kong Polytechnic University and Department of Ophthalmology, The University of Hong Kong | Hong Kong | No postcode | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38923965 | Derived | Chun RKM, Hon Y, Law TK, Wong KYQ, To CH, Shih KC, Leung CKS, Tse DYY. Combination effect of optical defocus and low dose atropine in myopia control: Study protocol for a randomized clinical trial. PLoS One. 2024 Jun 26;19(6):e0306050. doi: 10.1371/journal.pone.0306050. eCollection 2024. |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D001285 | Atropine |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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Eligible participants will be randomly allocated into 2 groups. One group will receive low dose atropine (0.01%) plus DIMS spectacles (ATD Group); another one will receive low dose atropine (0.01%) plus single vision spectacles (AT Group).
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Investigators, including ophthalmologists and optometrists, who are responsible for collection of data related to myopia progression and analysis of data will be blinded to study intervention.
| single vision spectacle lenses | Device | Single vision spectacle lenses will be given to this group of participants. |
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| Low dose atropine | Drug | 0.01% atropine administrated twice per day (1 drop in the morning and 1 drop at night before bedtime) will be given as intervention. |
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| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |