Dietary Supplement for Myopia Control

The Hong Kong Polytechnic University

Status: Not yet enrolling

Conditions: Myopia

Treatments: 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); Dietary Supplement: Oral dietary supplement provided in a capsule format (3 active capsules/ per day)

Study type: Interventional

Funder types: Other

Identifiers

NCT07406906

HSEARS20251202005

Details and patient eligibility

About

The purpose of this clinical trial is to investigate the changes in choroidal thickness and vasculature in myopic children following oral supplementation.

Full 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.

Enrollment: 156 estimated patients

Sex: All

Ages: 8 to 13 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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156 participants in 3 patient groups, including a placebo group

High concentration group

Experimental group

Description:

3 active capsules/ per day

Treatment:

Dietary Supplement: Oral dietary supplement provided in a capsule format (3 active capsules/ per day)

Low-concentration group

Experimental group

Description:

1 active capsule and 2 placebo capsules/per day

Treatment:

Dietary Supplement: Oral dietary supplement provided in a capsule format (1 active capsule and 2 placebo capsules/per day)

Control group

Placebo Comparator group

Description:

3 placebo capsules/per day

Treatment:

Other: Placebo control (3 placebo capsules/per day)