MyopiaNCT07406906
Dietary Supplement for Myopia Control
A study testing Oral dietary supplement provided in a capsule format (3 active capsules/ per day) in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The purpose of this clinical trial is to investigate the changes in choroidal thickness and vasculature in myopic children following oral supplementation. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Myopia
- What is being tested?
- Oral dietary supplement provided in a capsule format (3 active capsules/ per day)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 8-13 years
- Cycloplegic spherical equivalent refraction (SER) of -0.50 D to -5.00 D with astigmatism of 2.5 D or less and best-corrected visual acuity (BCVA) of 0.0 logarithm or more in either eye
- Anisometropia of 1.50 D or less
- Intraocular pressure of 10 mmHg to 21 mmHg in both eyes
- Willing to give written consent to participate in the study and accept random allocation in grouping
Who cannot join
- Ocular abnormalities leading to visual impairment
- Severe physiological and psychological diseases affecting follow-up
- Receiving previous myopia control treatment including but not limited to atropine therapy and orthokeratology in the past 3 months
- Use of any other dietary supplements containing DHA/EPA, Lutein, or Astaxanthin in the past 3 months
- Known history of allergy to any of the components of the dietary supplement or placebo, or history of an allergic reaction that required emergency treatment
- Children who had other contraindications identified by the investigators that made them unsuitable for participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
Hong Kong Polytechnic University
Hong Kong
PolyU Institutional Review Board, +852 2766 6379, institutional.review.board@polyu.edu.hk
Mingguang HE
About this study
Official title: The Effect of Dietary Supplements on Choroidal Thickness and Vasculature in Myopic Children: A Randomized, Double-Blind, Placebo-Controlled Trial
The purpose of this clinical trial is to investigate the changes in choroidal thickness and vasculature in myopic children following oral supplementation.
Read the detailed description
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.
- Conditions
- Myopia
- Being tested
- Oral dietary supplement provided in a capsule format (3 active capsules/ per day), Oral dietary supplement provided in a capsule format (1 active capsule and 2 placebo capsules/per day), Placebo control (3 placebo capsules/per day)
- Keywords
- oral supplements, choroidal thickness, choroidal blood flow
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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
| Study group | Role | What they receive |
|---|---|---|
| High concentration group | Experimental | 3 active capsules/ per day Receives: Dietary Supplement: Oral dietary supplement provided in a capsule format (3 active capsules/ per day) |
| Low-concentration group | Experimental | 1 active capsule and 2 placebo capsules/per day Receives: Dietary Supplement: Oral dietary supplement provided in a capsule format (1 active capsule and 2 placebo capsules/per day) |
| Control group | Placebo comparator | 3 placebo capsules/per day Receives: Other: Placebo control (3 placebo capsules/per day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Choroidal thickness will be measured every month from enrollment to the end of treatment at 3 months.
Secondary outcomes (4)
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.
Measured: Choroidal vasculature index (CVI) will be measured every month from enrollment to the end of treatment at 3 months.
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.
Measured: 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).
Measured: 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.
Measured: BCVA will be measured every month from enrollment to the end of treatment at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406906
- Sponsor's protocol ID
- HSEARS20260211011
- Status last verified
- Jul 2026
- First submitted
- 6 Feb 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dietary Supplements on Choroidal Thickness and Vasculature in Myopic Children: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07406906
- Acronym / sponsor ID
- HSEARS20260211011
- Conditions
- Myopia
- Keywords
- oral supplements, choroidal thickness, choroidal blood flow
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to investigate the changes in choroidal thickness and vasculature in myopic children following oral supplementation.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High concentration group | Experimental | Dietary Supplement: Oral dietary supplement provided in a capsule format (3 active capsules/ per day)3 active capsules/ per day |
| Low-concentration group | Experimental | Dietary Supplement: Oral dietary supplement provided in a capsule format (1 active capsule and 2 placebo capsules/per day)1 active capsule and 2 placebo capsules/per day |
| Control group | Placebo comparator | Other: Placebo control (3 placebo capsules/per day)3 placebo capsules/per day |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 8-13 years
- Cycloplegic spherical equivalent refraction (SER) of -0.50 D to -5.00 D with astigmatism of 2.5 D or less and best-corrected visual acuity (BCVA) of 0.0 logarithm or more in either eye
- Anisometropia of 1.50 D or less
- Intraocular pressure of 10 mmHg to 21 mmHg in both eyes
- Willing to give written consent to participate in the study and accept random allocation in grouping
Key exclusion criteria (6 listed)
- Ocular abnormalities leading to visual impairment
- Severe physiological and psychological diseases affecting follow-up
- Receiving previous myopia control treatment including but not limited to atropine therapy and orthokeratology in the past 3 months
- Use of any other dietary supplements containing DHA/EPA, Lutein, or Astaxanthin in the past 3 months
- Known history of allergy to any of the components of the dietary supplement or placebo, or history of an allergic reaction that required emergency treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral dietary supplement provided in a capsule format (3 active capsules/ per day)The active intervention in this study is an oral dietary supplement provided in a capsule format. The active ingredients include DHA/EPA and Astaxanthin. | Dietary supplement | High concentration group |
| Oral dietary supplement provided in a capsule format (1 active capsule and 2 placebo capsules/per day)The active intervention in this study is an oral dietary supplement provided in a capsule format. The active ingredients include DHA/EPA and Astaxanthin. | Dietary supplement | Low-concentration group |
| Placebo control (3 placebo capsules/per day)3 placebo capsules/per day | Other | Control group |
Primary outcome
Change in choroidal thickness measured by OCT
Time frame: Choroidal thickness will be measured every month from enrollment to the end of treatment at 3 months.
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.
4 secondary outcomes
Change in choroidal vasculature index
Time frame: Choroidal vasculature index (CVI) will be measured every month from enrollment to the end of treatment at 3 months.
Change in axial length
Time frame: Axial length will be measured every month from enrollment to the end of treatment at 3 months.
Change in cycloplegic spherical equivalent refraction
Time frame: 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)
Time frame: BCVA will be measured every month from enrollment to the end of treatment at 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral dietary supplement provided in a capsule format (3 active capsules/ per day) in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaojie WAN, MD (+852 8496 7212, xiaojie.wan@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in choroidal thickness measured by OCT (time frame: Choroidal thickness will be measured every month from enrollment to the end of treatment at 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.