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临床试验/NCT05778201
NCT05778201招募中1 期

To Study the Effects of Baby Drink on Vision Care

China Medical University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年3月8日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
入组人数
60
试验地点
2
主要终点
Eye fatigue questionnaire

研究概览

简要总结

Baby Drink is a formula based on lutein, mixed with blueberry fermented liquid, vitamins and minerals. Lutein is an effective antioxidant to prevent retinal damage caused by blue light, but it cannot be produced in the human body and depends on dietary intake. Blueberry fermented liquid is rich in polyphenolic compounds with excellent antioxidant capacity and the potential to reduce oxidative damage to eye cells caused by ultraviolet rays. With the prevalence of 3C products, myopia patients are increasing year by year in various regions, and suffer from eye diseases or vision loss with different degrees of complications. In this study, the subjects were provided with Baby Drink and tracked the degree of visual fatigue by regular questionnaires, and measured for visual acuity, axial length and diopter. The aim of this study is to investigate the protection of Baby Drink on visual acuity and visual fatigue.

详细描述

  1. Visual acuity measurement: Snellen's Chart was used to measure visual acuity.
  2. Refractive examination: Measure binocular refraction with Open Field computer refractor (Shin-Nippon Nvision K5001 Wide View).
  3. Measuring the axial length of the eye: Use the multifunctional optical eyeball length measuring instrument (Lenstar) to measure the distance from the instrument to the optical paths such as the cornea, lens, and retina, and then convert to the axial length of the eye.
  4. Corneal radian measurement: Use a keratometer (Bausch & Lomb Keratometer) to measure the corneal radian and curvature, and estimate the degree of corneal astigmatism.
  5. Visual fatigue questionnaire survey: A visual fatigue scale questionnaire was designed using Ocular Surface Disease Index (OSDI) and Computer Vision Syndrome (CVS).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 20 or over
  • Willing to participate in this study and sign the subject's consent form
  • Myopia less than 700 degrees

排除标准

  • Have consumed related eye care products in past 3 months
  • Those who have eye infection in the past 3 months
  • People who have been diagnosed with any eye diseases in past 3 months
  • Those who are allergic to cicadae

结局指标

主要结局

Eye fatigue questionnaire

时间窗: 1 month

1. Eye fatigue were evaluated according to The Ocular Surface Disease Index (OSDI) introduced in 1997 by the Outcomes Research Group (Allergan Inc., Irvine, CA). 2. Content including: (1) Eye swelling, (2) Eye soreness, (3) Photophobia, (4) Blurred vision, (5) Dry eye, (6) Foreign body sensation, (7) Tearing, (8) General discomfort related to eye fatigue. 3. Scores are expressed on a scale of 0-3. 0 = No symptoms , 1 = Occasionally (≤1 time/day), 2 = Sometimes (1-3 times/day), 3 = Frequently (\>3 times/day), a low score means less visual fatigue and better eye quality.

Best vision test

时间窗: 1 month

1. Visual acuity was tested with the Snellen Eye Test Chart and recorded with the score proposed by Snellen. 2. Subjects were asked to stand 20 feet away to observe the snellen E-chart and record the smallest visual mark. 3. Recording method: 20/20 (1.0) is defined as normal vision, lower than this score indicates that the subject has ametropia, and higher than this indicates that the subject's vision is higher than the general standard

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hui Wen Lin

Clinical Professor

China Medical University Hospital

研究点 (2)

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