Lactic Acid Bacteria for Reducing Blue Light-Induced Eye Fatigue
27. juli 2026 opdateret af: Synbio Tech Inc.
The Application of Lactic Acid Bacteria on Reducing Blue Light-Induced Eye Fatigue in Middle-Aged Adults
With the widespread use of digital devices and prolonged screen exposure, digital eye strain (DES), also known as computer vision syndrome, has become a global public health concern.
Emerging evidence suggests that the gut-eye axis may play an important role in ocular health, as gut microbiota imbalance is associated with systemic inflammation and oxidative stress.
Specific probiotics may help alleviate eye discomfort through modulation of immune responses and enhancement of antioxidant defense mechanisms.
This randomized, double-blind, placebo-controlled study aims to evaluate the efficacy of supplementation with specific probiotics, Bifidobacterium longum BL531 and Lactobacillus reuteri LR1349, in improving digital eye strain symptoms in adults.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
150
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Han-Yin Hsu
- Telefonnummer: +886-07-6955680 Ext. 2923
- E-mail: hanin@synbiotech.com.tw
Undersøgelse Kontakt Backup
- Navn: Chia-Chia Lee
- Telefonnummer: +886-07-6955680 Ext. 2921
- E-mail: cclee@synbiotech.com.tw
Studiesteder
-
-
-
Taipei, Taiwan, 106
- National Taiwan Normal University
-
Kontakt:
- Chi-Hao Wu, Professor
- Telefonnummer: +886-02-7749-1427
- E-mail: chwu@ntnu.edu.tw
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Men and women aged 20-65 years
- Daily digital screen use >6 hours for at least 1 year
- Mild to severe digital eye strain (CVS-Q score ≥ 6)
- Mild to moderate dry eye symptoms (OSDI ≥ 13)
Exclusion Criteria:
- Amblyopia or strabismus
- Severe eye diseases (e.g., glaucoma , cataract , retinal disorders, severe corneal disease)
- Ocular surgery within the past 12 months
- Chronic systemic diseases (e.g., uncontrolled diabetes, autoimmune disease, severe liver/kidney impairment, cancer)
- Recent use (<1 months) of steroids, antibiotics, immunosuppressants, probiotics, prebiotics, or eye-health supplements
- Pregnant or breastfeeding
- Allergy to probiotics or study product ingredients
- Eating disorders, psychiatric illness, or cognitive impairment affecting compliance
- Any condition judged unsuitable by the investigator
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
Subjects assigned to the placebo group will take one placebo capsule daily within 30 minutes before breakfast throughout the 12-week intervention period.
|
Maltodextrin
|
|
Eksperimentel: BL531_low dose
Subjects assigned to each intervention group will take one capsule daily within 30 minutes before breakfast throughout the 12-week intervention period.
|
1×10^10 cfu/day
|
|
Eksperimentel: BL531_high dose
Subjects assigned to each intervention group will take one capsule daily within 30 minutes before breakfast throughout the 12-week intervention period.
|
2.5×10^10 cfu/day
|
|
Eksperimentel: LR1349_low dose
Subjects assigned to each intervention group will take one capsule daily within 30 minutes before breakfast throughout the 12-week intervention period.
|
1×10^10 cfu/day
|
|
Eksperimentel: LR1349_high dose
Subjects assigned to each intervention group will take one capsule daily within 30 minutes before breakfast throughout the 12-week intervention period.
|
2.5×10^10 cfu/day
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Computer Vision Syndrome Questionnaire (CVS-Q)
Tidsramme: Baseline, Week 6, Week 12
|
The CVS-Q is a questionnaire used to assess digital eye strain associated with prolonged digital screen use.
It includes 16 symptoms related to screen exposure.
Total scores are classified as 0-5 (none/minimal), 6-12 (mild), 13-18 (moderate), and ≥19 (severe), with scores ≥6 indicating clinically significant digital eye strain.
|
Baseline, Week 6, Week 12
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Ocular Surface Disease Index (OSDI)
Tidsramme: Baseline, Week 6, Week 12
|
The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire used to assess the severity of dry eye symptoms and their impact on vision-related function and daily activities.
Total scores range from 0 to 100, with higher scores indicating greater symptom severity.
|
Baseline, Week 6, Week 12
|
|
Basic vision examination
Tidsramme: Baseline and Week 12
|
A comprehensive ophthalmic examination will be performed, including uncorrected distance and near visual acuity, automated refraction, presbyopia assessment, distance and near vision correction, intraocular pressure measurement, and external eye photography for conjunctival hyperemia assessment.
|
Baseline and Week 12
|
|
Pupillary Response Test
Tidsramme: Baseline and Week 12
|
Pupillary response testing will be performed using the Oculus Pentacam HR or an equivalent device to evaluate pupil size and response time under light and dark conditions.
This assessment provides information on the visual system's adaptation to changes in illumination.
|
Baseline and Week 12
|
|
Tear Secretion Assessment
Tidsramme: Baseline and Week 12
|
Tear meniscus height will be measured using the OS1000 Corneal Topographer (SBM sistemi, Italy) or an equivalent device as an indicator of tear secretion.
|
Baseline and Week 12
|
|
Non-Invasive Tear Break-Up Time (NIBUT)
Tidsramme: Baseline and Week 12
|
Non-invasive tear break-up time (NIBUT) will be measured using the OS1000 Corneal Topographer (SBM sistemi, Italy) or an equivalent device to evaluate tear film stability.
A shorter NIBUT is commonly associated with dry eye symptoms and digital eye strain.
|
Baseline and Week 12
|
|
Corneal Tomography and Topography Analysis
Tidsramme: Baseline and Week 12
|
Corneal tomography and topography analysis will be performed using the Oculus Pentacam HR or an equivalent device to evaluate corneal morphology, curvature, thickness, and regularity.
|
Baseline and Week 12
|
|
Accommodative Function Assessment
Tidsramme: Baseline and Week 12
|
Accommodative function will be assessed using the ARK-1s Auto Ref-Keratometer (NIDEK, Japan) or an equivalent device to evaluate the eye's focusing ability and quantify accommodative responses associated with ciliary muscle contraction and relaxation.
|
Baseline and Week 12
|
|
Worth Four Dot Test
Tidsramme: Baseline and Week 12
|
The Worth Four Dot Test will be used to assess binocular vision and fusion ability by evaluating responses to red and green visual targets, including the presence of suppression or diplopia.
|
Baseline and Week 12
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
31. august 2027
Studieafslutning (Anslået)
31. december 2027
Datoer for studieregistrering
Først indsendt
27. juli 2026
Først indsendt, der opfyldte QC-kriterier
27. juli 2026
Først opslået (Faktiske)
30. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- C202605115
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .