Dietary Supplement for Myopia Control

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myopia
• Intervention / Treatment: Dietary supplement: Oral dietary supplement provided in a capsule format (3 active capsules/ per day); Dietary supplement: Oral dietary supplement provided in a capsule format (1 active capsule and 2 placebo capsules/per day); Other: Placebo control (3 placebo capsules/per day)

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 Type: Interventional
• Enrollment (Estimated): 156
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaojie WAN, MD; Phone Number: +852 8496 7212; Email: xiaojie.wan@connect.polyu.hk
• Study Contact Backup: Name: Yue WU, MD; Phone Number: +852 5171 7556; Email: yuewy.wu@connect.polyu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Hong Kong Polytechnic University
    • Contact: PolyU Institutional Review Board; Phone Number: +852 2766 6379; Email: institutional.review.board@polyu.edu.hk
    • Principal Investigator: Mingguang HE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High concentration group; 3 active capsules/ per day	Dietary supplement: 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.
Experimental: Low-concentration group; 1 active capsule and 2 placebo capsules/per day	Dietary supplement: 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.
Placebo Comparator: Control group; 3 placebo capsules/per day	Other: Placebo control (3 placebo capsules/per day); 3 placebo capsules/per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.
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.

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Estimated): January 30, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: oral supplements, choroidal thickness, choroidal blood flow
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: HSEARS20251202005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No