The Application of Lactic Acid Bacteria on Reducing Blue Light-Induced Eye Fatigue in Middle-Aged Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Computer Vision Syndrome Questionnaire (CVS-Q)
研究概览
简要总结
With the widespread use of digital devices and prolonged screen exposure, digital eye strain (DES), also known as computer vision syndrome, has become a global public health concern. Emerging evidence suggests that the gut-eye axis may play an important role in ocular health, as gut microbiota imbalance is associated with systemic inflammation and oxidative stress. Specific probiotics may help alleviate eye discomfort through modulation of immune responses and enhancement of antioxidant defense mechanisms. This randomized, double-blind, placebo-controlled study aims to evaluate the efficacy of supplementation with specific probiotics, Bifidobacterium longum BL531 and Lactobacillus reuteri LR1349, in improving digital eye strain symptoms in adults.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 20-65 years
- •Daily digital screen use >6 hours for at least 1 year
- •Mild to severe digital eye strain (CVS-Q score ≥ 6)
- •Mild to moderate dry eye symptoms (OSDI ≥ 13)
排除标准
- •Amblyopia or strabismus
- •Severe eye diseases (e.g., glaucoma , cataract , retinal disorders, severe corneal disease)
- •Ocular surgery within the past 12 months
- •Chronic systemic diseases (e.g., uncontrolled diabetes, autoimmune disease, severe liver/kidney impairment, cancer)
- •Recent use (<1 months) of steroids, antibiotics, immunosuppressants, probiotics, prebiotics, or eye-health supplements
- •Pregnant or breastfeeding
- •Allergy to probiotics or study product ingredients
- •Eating disorders, psychiatric illness, or cognitive impairment affecting compliance
- •Any condition judged unsuitable by the investigator
结局指标
主要结局
Computer Vision Syndrome Questionnaire (CVS-Q)
时间窗: Baseline, Week 6, Week 12
The CVS-Q is a questionnaire used to assess digital eye strain associated with prolonged digital screen use. It includes 16 symptoms related to screen exposure. Total scores are classified as 0-5 (none/minimal), 6-12 (mild), 13-18 (moderate), and ≥19 (severe), with scores ≥6 indicating clinically significant digital eye strain.
次要结局
- Ocular Surface Disease Index (OSDI)(Baseline, Week 6, Week 12)
- Basic vision examination(Baseline and Week 12)
- Pupillary Response Test(Baseline and Week 12)
- Tear Secretion Assessment(Baseline and Week 12)
- Non-Invasive Tear Break-Up Time (NIBUT)(Baseline and Week 12)
- Corneal Tomography and Topography Analysis(Baseline and Week 12)
- Accommodative Function Assessment(Baseline and Week 12)
- Worth Four Dot Test(Baseline and Week 12)