To Study the Effects of Baby Drink on Vision Care

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.

Study Overview

• Status: Recruiting
• Conditions: Myopia
• Intervention / Treatment: Biological: Baby Drink group

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Hui Wen Lin, ph.D; Phone Number: 5131 04-23323456; Email: d9138001@gmail.com
• Study Contact Backup: Name: Tzu Chun Chen, Master; Phone Number: 0915451008; Email: cherish4488@gmail.com

Study Locations

• Taiwan
  • Taichung, Taiwan, 413
    • Recruiting
    • Asia University
    • Contact: Hui Wen Lin, Ph.D; Phone Number: 5131 0423323456; Email: d9138001@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Have consumed related eye care products in past 3 months
2. Those who have eye infection in the past 3 months
3. People who have been diagnosed with any eye diseases in past 3 months
4. Those who are allergic to cicadae

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baby Drink group; 1 package/ day for 1 month	Biological: Baby Drink group; 1 packge (20 ml)/ day for 1 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month
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	1 month

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: Hui Wen Lin, ph.D, Asia University

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2023
• Primary Completion (Anticipated): December 15, 2023
• Study Completion (Anticipated): December 15, 2023

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: March 19, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 19, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CRREC-111-088

Drug and device information, study documents

• 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