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Not yet recruiting NCT07406906

Dietary Supplement for Myopia Control

No phase Interventional Myopia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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).
Who it may be relevant to
Registry conditions: Myopia. Basic parameters: 8 years — 13 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Effect of Dietary Supplements on Choroidal Thickness and Vasculature in Myopic Children: A Randomized, Double-Blind, Placebo-Controlled Trial

Overview

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.

Interventions

  • 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.
  • 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.
  • Other Placebo control (3 placebo capsules/per day)
    3 placebo capsules/per day

Primary outcome measures

  • 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.]
Secondary outcome measures (4)
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • Hong Kong Polytechnic University — Hong Kong

Identifiers

NCT: NCT07406906 · HSEARS20260211011

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗