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Clinical Trials/NCT05778409
NCT05778409CompletedEarly Phase 1

To Study the Effects of Cordyceps Cicadae on Vision Care

China Medical University Hospital1 site in 1 country60 target enrollmentStarted: March 8, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Early Phase 1
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Best vision test

Study Overview

Brief Summary

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.

Detailed Description

  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).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • 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

Arms & Interventions

Cordyceps Cicadae extract group

Experimental

500 mg/ day for 1 month

Intervention: Cordyceps cicadae extract (Biological)

Outcomes

Primary Outcomes

Best vision test

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hui Wen Lin

Clinical Professor

China Medical University Hospital

Study Sites (1)

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