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临床试验/NCT07135180
NCT07135180进行中(未招募)不适用

Exploring the Eye Care Benefits of Cordyceps Cicadae Across Different Age Groups

China Medical University Hospital2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
200
试验地点
2
主要终点
Tear break-up time

研究概览

简要总结

The aim of this study is to evaluate the underlying mechanisms of consuming two capsules (each containing 250 mg of Cordyceps cicadae mycelium, for a total intake of 500 mg) of Grape King's Cordyceps cicadae mycelium through a clinical human trial. By including participants from different age groups, the study investigates whether improvements in visual acuity and the alleviation of eye fatigue are associated with changes in ocular accommodation, tear film stability, and blood circulation. The ultimate goal is to develop a health supplement beneficial for vision.

详细描述

Over the past decade, vision problems caused by electronic screen use across all age groups have gradually shifted from being primarily occupational health issues to broader public health concerns. Moreover, studies have shown that prolonged computer use may lead to blurred vision at near or far distances-one of the hallmark symptoms of Computer Vision Syndrome (CVS), also known as Digital Eye Strain (DES). A key contributing factor is inaccurate accommodative response, either due to underaccommodation or overaccommodation while focusing on a visual target, leading to visual fatigue.

Sheedy et al. identified common symptoms of visual fatigue, including eye tiredness, discomfort, burning, irritation, pain, soreness, eye ache, double vision, photophobia, blurriness, itching, tearing, dryness, and a foreign body sensation. These symptoms are generally classified into two categories: the first, external symptoms-such as burning, irritation, dryness, and tearing-are associated with dry eye syndrome; the second, internal symptoms-such as eye fatigue, headache, ocular pain, diplopia, and blurred vision-are typically linked to refractive errors, accommodative dysfunction, or convergence anomalies.

In addition, a study by Tosha et al. found that subjects who experienced greater visual discomfort after prolonged computer use exhibited a significant increase in accommodative lag, suggesting a link to accommodative fatigue. Overall, these conditions are closely related to visual fatigue, and if left unmanaged, may impair visual function over time and potentially contribute to the progression of myopia.

Therefore, appropriately managing screen time, along with adequate visual rest and eye care strategies, is essential for maintaining healthy accommodation and visual function. Previous studies have demonstrated that Cordyceps cicadae mycelium can effectively relieve eye fatigue and improve visual acuity; however, the underlying mechanisms remain unclear. The Cordyceps cicadae mycelium used in this study has passed 16 safety evaluation tests and has been granted a New Dietary Ingredient (NDI No. 834) number by the U.S. Food and Drug Administration (FDA), as well as food clearance approval by Japanese customs. The product is supplied by Grape King Bio. This study aims to further investigate the eye-protective mechanisms of Cordyceps cicadae mycelium and its beneficial effects on visual health across different age groups.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • People with myopia less than 700 degrees
  • Willing to participate in this study and sign the consent form

排除标准

  • (1) Those who have recently consumed related eye care products
  • (2) Those who have had eye infections or surgery in the past three months
  • (3) Those who have been diagnosed with eye diseases by an ophthalmologist (such as glaucoma, cataracts, macular degeneration, diabetic retinopathy, etc., or have undergone eye surgery such as cataract surgery, retinal laser surgery, myopia laser surgery, etc., which will be excluded before accepting the case)
  • (4) Those who are allergic to cicada fungus

结局指标

主要结局

Tear break-up time

时间窗: 3 hours

Tear film break-up time (TBUT) on the corneal surface will be recorded in seconds using corneal topography.

Accommodative Facility

时间窗: 3 hours

Use +/- 0.50D flip mirror and special optometry cards to test the number of optometry cards that the patient can read within one minute and record the number of flip cycles.

Visual acuity measurement

时间窗: 3 hours

Examinations include (a) distance visual acuity (DVA) and (b) near visual acuity (NVA), recorded using the Snellen chart.

Choroidal thickness test

时间窗: 3 hours

Heidelberg SPECTRALIS optical coherence tomography (OCT) was used to examine the choroid thickness in micrometer of the subjects.

Meibomian gland observation

时间窗: 3 hours

The meibomian glands will be evaluated using corneal topography to document their morphology, quantity, and size.

Eye fatigue questionnaire

时间窗: 3 hours

The Ocular Surface Disease Index (OSDI) was used to assess visual fatigue. The subjects were asked to fill in the questionnaire before and after taking the medicine, and the scores were calculated. Symptoms include eyestrain, discomfort, burning, irritation, pain, soreness, eye pain, double vision, photophobia, blurriness, itching, tearing, dryness, and foreign body sensation

Tear meniscus height (TMH)

时间窗: 3 hours

Tear meniscus height (TMH) will be evaluated using slit-lamp biomicroscopy and recorded in millimeters.

次要结局

  • Intraocular Pressure(3 hours)

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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