The Effect of Dietary Supplements on Choroidal Thickness and Vasculature in Myopic Children: A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Change in choroidal thickness measured by OCT
研究概览
简要总结
The purpose of this clinical trial is to investigate the changes in choroidal thickness and vasculature in myopic children following oral supplementation.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control group
3 placebo capsules/per day
干预措施: Placebo control (3 placebo capsules/per day) (Other)
High concentration group
3 active capsules/ per day
干预措施: Oral dietary supplement provided in a capsule format (3 active capsules/ per day) (Dietary Supplement)
Low-concentration group
1 active capsule and 2 placebo capsules/per day
干预措施: Oral dietary supplement provided in a capsule format (1 active capsule and 2 placebo capsules/per day) (Dietary Supplement)
结局指标
主要结局
Change in choroidal thickness measured by OCT
时间窗: Choroidal thickness will be measured every month from enrollment to the end of treatment at 3 months.
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.
次要结局
- 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.)