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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 effect of bright light therapy, myopic defocus, atropine and the combination in myopia control in schoolchildren.
The present study is a multi-arm randomised clinical trial with a 24-month duration. Subjects will be healthy Hong Kong Chinese schoolchildren with low to moderate myopia. The aims are to determine the clinical effectiveness of bright light therapy on inhibiting myopia progression in schoolchildren, and to determine whether combination therapy using bright light therapy (BLT) and myopic defocus is more effective than monotherapy.
Study population Seven hundred and sixty Hong Kong Chinese children (152 in each) of A. Control group, B. BLT only group, C. BLT and Defocus Incorporated Multiple Segments (DIMS) group, D. BLT and atropine 0.01% group) and E. Atropine 0.01% group aged 7-12 years old will be recruited. They must not have had 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.
The eligible subjects will be randomly assigned into one of the four groups. Their cycloplegic refraction and axial length will be monitored every six months for 2 years. The changes in refractive errors and axial length between groups will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Subjects in control will receive single vision spectacle lenses and a placebo desk lamp | |
| BLT monotherapy | Experimental | Subjects in BLT monotherapy group will receive a high intensity light box for bright light therapy and single vision spectacle lenses |
|
| BLT and DIMS | Experimental | Subjects in BLT and DIMS group will receive a high intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses |
|
| BLT and atropine | Experimental | Subjects in BLT and atropine group will receive a high intensity light box for bright light therapy, single vision spectacle lens, and atropine 0.01% eye drop (twice a day) |
|
| Atropine monotherapy | Experimental | Subjects in atropine group will receive atropine 0.01% eye drop (twice a day) and single vision spectacle lenses |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High intensity light box for bright light therapy and single vision spectacle lenses | Other | High intensity light box for bright light therapy and single vision spectacle lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cycloplegic Refraction Change in spherical equivalent refraction (SER) | Change in cycloplegic SER (in diopter) will be measured using an open field autorefractor | Baseline and 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Axial length | Axial length (mm) will be measured after cycloplegia using a non-contact optical biometer | Baseline and 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chi Ho To, PhD | School of Optometry, 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 |
|---|---|---|---|
| 40389302 | Derived | Hon Y, Chun RKM, Cheung BKK, Lam DMK, Kong ACW, Ho LM, Lam WC, Lam TC, Lam CS, Lian J, Morgan IG, To CH, Leung CKS, Tse DY. Effectiveness of bright light therapy and combination with myopic defocus for controlling myopic eye growth in schoolchildren: study protocol for a randomised controlled trial (phase 1). BMJ Open Ophthalmol. 2025 May 19;10(1):e002044. doi: 10.1136/bmjophth-2024-002044. |
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|
| High intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses | Other | High intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses |
|
| High intensity light box for bright light therapy and atropine 0.01% eye drop and and single vision spectacle lenses | Other | High intensity light box for bright light therapy and atropine 0.01% eye drop and and single vision spectacle lenses |
|
| Atropine 0.01% eye drop and and single vision spectacle lenses | Other | Atropine 0.01% eye drop and and single vision spectacle lenses |
|
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014467 | Ultraviolet Therapy |
| D001285 | Atropine |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D010789 | Phototherapy |
| D013812 | Therapeutics |
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
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