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The purpose of this clinical trial is to investigate the changes in choroidal thickness and vasculature in myopic children following oral supplementation.
Myopia commonly develops in childhood and is projected to affect nearly half of the global population by 2050, with high myopia posing a significant risk for irreversible vision loss. Although existing interventions can slow myopia progression, their use is limited by safety concerns, discomfort, variable efficacy, and accessibility, particularly in children. Therefore, exploring safe and accessible dietary oral supplements represents a promising alternative strategy for myopia control.
This study aims to conduct a 3-month, double-blind, placebo-controlled randomized clinical trial in myopic children to evaluate the effects of a specific dietary supplement on choroidal structure and vasculature and to explore its potential role in myopia control. The trial will compare changes in subfoveal and average choroidal thickness (ChT), choroidal vascularity index (CVI), axial length (AL), and spherical equivalent refraction (SER) among high-dose, low-dose, and placebo groups, assess the efficacy and safety of the combined supplementation. Subfoveal and average ChT, AL, visual acuity, cycloplegic SER, slit lamp, swept-source optical coherence tomography /angiography will be measured at 1-, 2-, and 3-month follow-up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High concentration group | Experimental | 3 active capsules/ per day |
|
| Low-concentration group | Experimental | 1 active capsule and 2 placebo capsules/per day |
|
| Control group | Placebo Comparator | 3 placebo capsules/per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral dietary supplement provided in a capsule format (3 active capsules/ per day) | Dietary Supplement | The active intervention in this study is an oral dietary supplement provided in a capsule format. The active ingredients include DHA/EPA and Astaxanthin. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in choroidal thickness measured by OCT | OCT and OCTA imaging will be performed using the swept-source OCT/OCTA system. ChT is defined as the perpendicular distance between the outer choroid-sclera margin and the retinal pigment epithelium-Bruch's complex. The average ChT and central ChT was calculated with the built-in software. | Choroidal thickness will be measured every month from enrollment to the end of treatment at 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in choroidal vasculature index | OCT and OCTA imaging will be performed using the swept-source OCT/OCTA system. The average CVI and central CVI was calculated with the built-in software. | Choroidal vasculature index (CVI) will be measured every month from enrollment to the end of treatment at 3 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaojie WAN, MD | Contact | +852 8496 7212 | xiaojie.wan@connect.polyu.hk | |
| Yue WU, MD | Contact | +852 5171 7556 | yuewy.wu@connect.polyu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong Polytechnic University | Hong Kong | Hong Kong |
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| Oral dietary supplement provided in a capsule format (1 active capsule and 2 placebo capsules/per day) | Dietary Supplement | The active intervention in this study is an oral dietary supplement provided in a capsule format. The active ingredients include DHA/EPA and Astaxanthin. |
|
| Placebo control (3 placebo capsules/per day) | Other | 3 placebo capsules/per day |
|
| Change in axial length |
Axial length, defined as the distance from the cornea to the retina, will be measured using an optical biometer. The average of three reliable measurements per eye will be recorded. |
| Axial length will be measured every month from enrollment to the end of treatment at 3 months. |
| Change in cycloplegic spherical equivalent refraction | Cycloplegia will be induced using a topical agent to temporarily paralyze the ciliary muscle. Refraction will then be measured using an autorefractor to determine the true Spherical Equivalent Refraction (SER). | Spherical equivalent refraction will be measured every month from enrollment to the end of treatment at 3 months. |
| Change in distance best-corrected visual acuity (BCVA) | BCVA will be measured using a visual chart at far distances. | BCVA will be measured every month from enrollment to the end of treatment at 3 months. |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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