To Study the Effects of Baby Drink on Vision Care
Primary Purpose
Myopia
Status
Recruiting
Phase
Early Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Baby Drink group
Sponsored by
About this trial
This is an interventional prevention trial for Myopia
Eligibility Criteria
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
Sites / Locations
- Asia universityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Baby Drink group
Arm Description
1 package/ day for 1 month
Outcomes
Primary Outcome Measures
Eye fatigue questionnaire
Eye fatigue were evaluated according to The Ocular Surface Disease Index (OSDI) introduced in 1997 by the Outcomes Research Group (Allergan Inc., Irvine, CA).
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.
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.
Best vision test
Visual acuity was tested with the Snellen Eye Test Chart and recorded with the score proposed by Snellen.
Subjects were asked to stand 20 feet away to observe the snellen E-chart and record the smallest visual mark.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05778201
First Posted
March 8, 2023
Last Updated
March 19, 2023
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05778201
Brief Title
To Study the Effects of Baby Drink on Vision Care
Official Title
To Study the Effects of Baby Drink on Vision Care
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2023 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
Baby Drink is a formula based on lutein, mixed with blueberry fermented liquid, vitamins and minerals. Lutein is an effective antioxidant to prevent retinal damage caused by blue light, but it cannot be produced in the human body and depends on dietary intake. Blueberry fermented liquid is rich in polyphenolic compounds with excellent antioxidant capacity and the potential to reduce oxidative damage to eye cells caused by ultraviolet rays. With the prevalence of 3C products, myopia patients are increasing year by year in various regions, and suffer from eye diseases or vision loss with different degrees of complications. In this study, the subjects were provided with Baby Drink and tracked the degree of visual fatigue by regular questionnaires, and measured for visual acuity, axial length and diopter. The aim of this study is to investigate the protection of Baby Drink on visual acuity and visual fatigue.
Detailed Description
Visual acuity measurement: Snellen's Chart was used to measure visual acuity.
Refractive examination: Measure binocular refraction with Open Field computer refractor (Shin-Nippon Nvision K5001 Wide View).
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.
Corneal radian measurement: Use a keratometer (Bausch & Lomb Keratometer) to measure the corneal radian and curvature, and estimate the degree of corneal astigmatism.
Visual fatigue questionnaire survey: A visual fatigue scale questionnaire was designed using Ocular Surface Disease Index (OSDI) and Computer Vision Syndrome (CVS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Baby Drink Intervention group
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Baby Drink group
Arm Type
Experimental
Arm Description
1 package/ day for 1 month
Intervention Type
Biological
Intervention Name(s)
Baby Drink group
Intervention Description
1 packge (20 ml)/ day for 1 month
Primary Outcome Measure Information:
Title
Eye fatigue questionnaire
Description
Eye fatigue were evaluated according to The Ocular Surface Disease Index (OSDI) introduced in 1997 by the Outcomes Research Group (Allergan Inc., Irvine, CA).
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.
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.
Time Frame
1 month
Title
Best vision test
Description
Visual acuity was tested with the Snellen Eye Test Chart and recorded with the score proposed by Snellen.
Subjects were asked to stand 20 feet away to observe the snellen E-chart and record the smallest visual mark.
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
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Wen Lin, ph.D
Phone
04-23323456
Ext
5131
Email
d9138001@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tzu Chun Chen, Master
Phone
0915451008
Email
cherish4488@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Wen Lin, ph.D
Organizational Affiliation
Asia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asia university
City
Taichung
ZIP/Postal Code
413
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Wen Lin, Ph.D
Phone
0423323456
Ext
5131
Email
d9138001@gmail.com
12. IPD Sharing Statement
Learn more about this trial
To Study the Effects of Baby Drink on Vision Care
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