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Набор скоро начнётся NCT07406906

Dietary Supplement for Myopia Control

Без фазы С лечением Myopia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 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).
Кому может быть актуально
Состояния в реестре: Myopia. Базовые параметры: 8 лет — 13 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Гонконг
Следующий шаг
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Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

  • Пищевая добавка 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.
  • Пищевая добавка 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.
  • Другое Placebo control (3 placebo capsules/per day)
    3 placebo capsules/per day

Первичные конечные точки

  • Change in choroidal thickness measured by OCT [Срок оценки: Choroidal thickness will be measured every month from enrollment to the end of treatment at 3 months.]
Вторичные конечные точки (4)
  • Change in choroidal vasculature index [Срок оценки: Choroidal vasculature index (CVI) will be measured every month from enrollment to the end of treatment at 3 months.]
  • Change in axial length [Срок оценки: Axial length will be measured every month from enrollment to the end of treatment at 3 months.]
  • Change in cycloplegic spherical equivalent refraction [Срок оценки: 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) [Срок оценки: BCVA will be measured every month from enrollment to the end of treatment at 3 months.]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Гонконг · 1 центр
  • Hong Kong Polytechnic University — Гонконг

Идентификаторы

NCT: NCT07406906 · HSEARS20260211011

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗