Effects of a Combination of Polyphenol-rich Extracts on the Protection of Retinal Cells Against Blue Light in the Prevention of Ocular Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- DEQS (Dry Eye-Related Quality-of-Life) index
研究概览
简要总结
The aim of the study is to confirm that daily supplementation with a product containing a standardized combination of polyphenol-rich extracts has a protective effect against potential blue-light-induced damage to retinal cells.
详细描述
Randomized, double-blind, parallel study conducted under medical supervision on a group of 54 volunteers exposed to blue-light for 6-8h a day. Patients receive one of the investigational products or placebo for 6 weeks. Study parameters: OCT (optical coherence tomography), Amsler test, Computerized Perimetry, Schirmer test. In addition, subjective symptoms will be assessed using the Visual Analog Scale (VAS) method and a Dry Eye-Related Quality-of-Life Questionnaire. The studied parameters will be measured before and after supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women and men, 25-45 years old.
- •Signed informed consent.
- •Volunteers who do not use glasses or contact lenses.
- •Volunteers exposed to blue light for at least 6 - 8 hours a day.
排除标准
- •Intake of supplements containing plant extracts, polyphenols or anthocyanins.
- •Participation in another clinical trial.
- •Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant and other gastrointestinal diseases that may affect the results of the study.
- •Women who are pregnant, planning to become pregnant during the study, or breastfeeding.
- •Use of drugs that cause impaired vision or impaired tear secretion (including digoxin, fluoroquinolones, metronidazole, hydrochlorothiazide, retinoids).
- •Current use of eye drops in the treatment of ocular diseases.
- •Ocular diseases.
结局指标
主要结局
DEQS (Dry Eye-Related Quality-of-Life) index
时间窗: Baseline, 6 weeks
Subjective symptom questionnaire assessment
Visual Analogue Scale
时间窗: Baseline, 6 weeks
Subjective symptom assessment
次要结局
- Optical Coherence Tomography(Baseline, 6 weeks)
- Schirmer test,(Baseline, 6 weeks)
- Computerized Perimetry(Baseline, 6 weeks)
- Amsler test(Baseline, 6 weeks)