Visual Acuity, Accommodation, Dry Eye
Conditions
Brief summary
The objective of this study is to evaluate, through a clinical human consumption trial, the effects of taking two capsules (each containing 250 mg of Cordyceps cicadae mycelium, for a total intake of 500 mg per dose) of Grape King Cordyceps cicadae mycelium on visual function and anti-fatigue performance in esports athletes.
Detailed description
This study aims to enroll 12 participants (aged 20-30 years), who are esports players, through oral announcements for recruitment. The anticipated source of participants will be students from the Department of Multimedia Game Development and Applications, Hungkuang University of Science and Technology, second-year and above. On the day prior to the trial, participants will undergo a baseline ophthalmic examination (serving as the control values). Following the baseline assessment, participants will undergo ophthalmic examinations after 1 hour and 2 hours of esports training, respectively, resulting in a total of three measurements. All data will be recorded in the case report form (CRF). On the day of the trial, participants will first undergo an ophthalmic examination. After completion, all 12 participants will be randomly allocated into groups using the QuickCalcs randomization tool (GraphPad Software, https://www.graphpad.com/quickcalcs/randomize1/). Based on the random allocation, capsule packages labeled with codes 001 to 012 will be prepared, containing either the investigational product or placebo. Each package will be distributed to the corresponding participant. Of the 12 participants, 3 will be assigned to the placebo group, and 9 will be assigned to the Cordyceps cicadae mycelium group. Participants will undergo ophthalmic examinations at 1 hour and 2 hours post-administration, and the results will be recorded in the CRF. The investigational product will be in capsule form, containing Cordyceps cicadae mycelium (250 mg per capsule) and excipients, with no other additives. The placebo will have the same excipients and capsule composition, except without the mycelium. Each participant will take a single oral dose on the test day (2 capsules). All investigational products and placebos will be provided by Grape King Bio Ltd.
Interventions
DIETARY_SUPPLEMENTCordyceps cicadae
Cordyceps cicadae 500mg
DIETARY_SUPPLEMENTBlank control
Blank control
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* People with myopia less than 700 degrees * Willing to participate in this study and sign the consent form
Exclusion criteria
* (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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear break-up time | 3 hours | Tear film break-up time (TBUT) on the corneal surface will be recorded in seconds using corneal topography. |
| Eye fatigue questionnaire | 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 |
| Accommodative Facility | 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 | 3 hours | Examinations include (a) distance visual acuity (DVA) and (b) near visual acuity (NVA), recorded using the Snellen chart. |
| Intraocular Pressure | 3 hours | The intraocular pressure (IOP) of the subjects was measured by non-contact intraocular pressure measurement in mmHg. |
| Tear meniscus height (TMH) | 3 hours | Tear meniscus height (TMH) will be evaluated using slit-lamp biomicroscopy and recorded in millimeters. |
| Meibomian gland observation | 3 hours | The meibomian glands will be evaluated using corneal topography to document their morphology, quantity, and size. |
Countries
Taiwan
Outcome results
None listed