Eye
Conditions
Brief summary
To assess the efficacy of blueberry chewable tablets on Eye Health
Interventions
DIETARY_SUPPLEMENTPlacebo tablets
consume 2 tablets per day for 8 weeks
DIETARY_SUPPLEMENTBlueberry Chewable Tablets
consume 2 tablets per day for 8 weeks
Sponsors
TCI Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult men and women over 20 years old * Use 3C products over 6 hours per day * Symptoms of dry eyes or tired eyes * Tear Break-Up Time is 10 seconds less * No history of ocular surgery (strabismus surgery, refractive surgery etc.)
Exclusion criteria
* Have systemic diseases affecting the front surface of the eyes. * Long-term use of drugs or eye drops that affect the condition of the front surface of the eyes * Long-term contact lens wear
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Schirmer's test | 8 weeks | Schirmer's test determines whether the eye produces enough tears to keep it moist. Units: mm (in 5minutes) |
| Changes of tear meniscus height | 8 weeks | Slit lamp Ocular Surface Analyzer is utilized to measure tear meniscus height. Units: mm |
| Changes of non-invasive tear break-up time (NITBUT) | 8 weeks | Ocular Surface Analyzer is utilized to measure non-invasive tear break-up time. Units: sec |
| Tear break-up time (TBUT) | 8 weeks | Slit lamp ocular Surface Analyzer is utilized to measure fist tear break-up time with slit lamp. Units: sec |
| Changes of accommodation | 8 weeks | Speedy-I is utilized to measure the accommodative micro fluctuation test of the ciliary muscle. Units: HFC |
| Ocular Surface Disease Index (OSDI) | 8 weeks | The Ocular Surface Disease Index (OSDI) is a 12-item scale for the assessment of symptoms related to dry eye disease and their effect on vision. Units: point |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Amplitude of Flipper facility | 8 weeks | Vergence facility (VF) was measured by using a prism flipper to evaluate the ability of the fusional vergence at near with +/-2.00 flipper. Units: cpm |
| Changes of eye pressure | 8 weeks | Eye pressure is measured in millimeters of mercury (mm Hg). |
| Changes of Fundus photography | 8 weeks | The fundus is the back of the eye and includes the retina, optic nerve, and retinal blood vessels. |
| Changes of Intraocular pressure (IOP) | 8 weeks | Eye pressure is measured in millimeters of mercury (mm Hg). Units: mmHg |
| Changes of Near point of convergence (NPC) | 8 weeks | RAF rule were initiated in order to normalize NPC. Record as break/recovery. Units: cm |
| Changes of Stereo vision | 8 weeks | The Randot Stereotest is utilized to evaluate the depth perception. Units: sec |
| Changes of binocular motor fusion | 8 weeks | The test is utilized to evaluate to assess binocular motor fusion, specifically the extent to which a patient can maintain binocular single vision (BSV) in the presence of increasing vergence demands. Units: prism |
| Changes of Amplitude of accommodation (AA) | 8 weeks | The amplitude of accommodation is the maximum potential increase in optical power that an eye can achieve in adjusting its focus. It refers to a certain range of object distances for which the retinal image is as sharply focused as possible. Units: diopter |
Countries
Taiwan
Outcome results
None listed