NCT06877494已完成2 期
Exploratory Study on the Effects of Fish Oil Supplements on Choroidal Thickness and Blood Flow Perfusion in Children and Adolescents
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Axial length
研究概览
简要总结
The goal of this clinical trial is to test the effect of fish oil supplement in terms of vision in children and adolescents. The main question it aims to answer is:
the differences in changes of choroidal thickness, choroidal blood flow, axial length, and visual acuity between the intervention group and the control group Participants will take the fish oil supplement. a baseline examination will be conducted, followed by follow-up visits at 15, 30, and 90 days after the start of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age range: 6-9 years old, gender unspecified;
- •Equivalent spherical power after unilateral cycloplegic eye ranging from 0.75D to -0.5D, with astigmatism not exceeding 1.5D;
- •Best corrected visual acuity of at least 1.0;
- •Ability to sign an informed consent form with the presence and understanding of a parent or guardian.
排除标准
- •Allergy or intolerance to ω-3 PUFAs or cycloplegics;
- •Strabismus, history of eye surgery (including strabismus correction surgery), other eye diseases, or systemic diseases;
- •Currently using myopia prevention measures.
研究组 & 干预措施
no-treatment control group
No Intervention
No intervention measures are applied
fish oil supplement group
Experimental
Twice a day, with one dose of DHA 300mg: EPA 60mg, for a continuous intervention of 90 days
干预措施: fish oil (Dietary Supplement)
结局指标
主要结局
Axial length
时间窗: 15±2 days, 30±2 days, and 90±2 days
the change of axial length
次要结局
- change in equivalent spherical(15±2 days, 30±2 days, and 90±2 days)
研究者
研究点 (1)
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