Myopia Control Using Bright Light Therapy and Myopic Defocus
Study Details
Study Description
Brief Summary
The purpose of the study is to investigate the effect of bright light therapy, myopic defocus, and the combination in myopia control in schoolchildren.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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 Four hundred and fifty six Hong Kong Chinese children (152 in each of A. Control group, B. BLT only group and C. BLT and Defocus Incorporated Multiple Segments (DIMS) 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control Subjects in control will receive single vision spectacle lenses and a placebo desk lamp |
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| Experimental: BLT monotherapy Subjects in BLT monotherapy group will receive a high intensity light box for bright light therapy and single vision spectacle lenses |
Other: A high intensity light box and myopic defocus
In this study, the effect of bright light given by a high intensity light box and its combination with myopic defocus will be given as interventions. Myopic defocus will be delivered by Defocus Incorporated Multiple Segments (DIMS) spectacle lenses.
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| Experimental: BLT and DIMS 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 |
Other: A high intensity light box and myopic defocus
In this study, the effect of bright light given by a high intensity light box and its combination with myopic defocus will be given as interventions. Myopic defocus will be delivered by Defocus Incorporated Multiple Segments (DIMS) spectacle lenses.
|
Outcome Measures
Primary Outcome Measures
- Cycloplegic Refraction Change in spherical equivalent refraction (SER) [Baseline and 2 years]
Change in cycloplegic SER (in diopter) will be measured using an open field autorefractor
Secondary Outcome Measures
- Axial length [Baseline and 2 years]
Axial length (mm) will be measured after cycloplegia using a non-contact optical biometer
Eligibility Criteria
Criteria
Inclusion Criteria:
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Myopia of at least -0.75D (spherical equivalent) in both eyes
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Age at enrolment: 7-12 year; Hong Kong Chinese
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Astigmatism and anisometropia: 1.50D or less
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Spectacle corrected monocular visual acuity (VA): 0.0 logMAR or better
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Parents' understanding and acceptance of random allocation of grouping and masking
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Able to wear the prescribed spectacle, put on eye drop and undergo light therapy daily.
Exclusion Criteria:
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Eye disease or binocular vision problems (e.g., strabismus, amblyopia, oculomotor nerve palsies, corneal disease, etc.)
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Previous intraocular or corneal surgery
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Systemic disease that may affect vision, vision development (e.g. endocrine, cardiac and respiratory diseases, diabetes, Down syndrome, etc.)
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Allergy to atropine
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Previous gas permeable, soft bifocal, or orthokeratology contact lens wear or bifocal/PAL/specific myopic control spectacle wear or use of atropine or pirenzepine (longer than 1 month of wear)
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Previous or current participation in myopia control studies
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre for Myopia Research, The Hong Kong Polytechnic University and Department of Ophthalmology, The University of Hong Kong | Hong Kong | Hong Kong | No postcode |
Sponsors and Collaborators
- The Hong Kong Polytechnic University
- The University of Hong Kong
Investigators
- Principal Investigator: Chi Ho To, PhD, School of Optometry, The Hong Kong Polytechnic University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R5032-18