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临床试验/NCT05778409
NCT05778409已完成早期 1 期

To Study the Effects of Cordyceps Cicadae on Vision Care

China Medical University Hospital1 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
干预措施

试验速览

阶段
早期 1 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Best vision test

研究概览

简要总结

Cordyceps cicadae is a traditional Asian herbal medicine with a variety of bioactive substances and curative effects similar to Cordyceps Cicadae, and it has been reported that anti-dry eye and eye protection ingredients can be extracted. With the advancement of civilization, the number of patients with high myopia is increasing year by year and suffers from complications of dry eye or other eye diseases. In this study, the subjects were provided with cicadae extract or placebo in a double-blind manner, tracked the degree of visual fatigue by regular questionnaires, and measured for visual acuity, axial length and diopter. The purpose of this study is to investigate the effect of cicadae extract on visual acuity and visual fatigue, and to evaluate its potential as a health food ingredient.

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
Other
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

研究组 & 干预措施

Cordyceps Cicadae extract group

Experimental

500 mg/ day for 1 month

干预措施: Cordyceps cicadae extract (Biological)

结局指标

主要结局

Best vision test

时间窗: one 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

Eye fatigue questionnaire

时间窗: one 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.

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 (1)

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