NCT07406906

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
0mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Jan 2026Jun 2026

Study Start

First participant enrolled

January 30, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

February 23, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

February 6, 2026

Last Update Submit

February 19, 2026

Conditions

Myopia

Keywords

oral supplements, choroidal thickness, choroidal blood flow

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in choroidal vasculature index

    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 will be measured every month from enrollment to the end of treatment at 3 months.

  • Change in cycloplegic spherical equivalent refraction

    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 every month from enrollment to the end of treatment at 3 months.

Study Arms (3)

High concentration group

EXPERIMENTAL

3 active capsules/ per day

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

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

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

Interventions

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.

High concentration group
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.

Low-concentration group
Placebo control (3 placebo capsules/per day)OTHER

3 placebo capsules/per day

Control group

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Central Study Contacts

Xiaojie WAN, MD

CONTACT

+852 8496 7212xiaojie.wan@connect.polyu.hk

Yue WU, MD

CONTACT

+852 5171 7556yuewy.wu@connect.polyu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 12, 2026

Study Start

January 30, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

February 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)