Digital Eye Strain (DES)
Conditions
Keywords
Eye Fatigue, Probiotics, Digital Eye Strain, Blue Light
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
Maltodextrin
DIETARY_SUPPLEMENTBL531_low dose
1×10\^10 cfu/day
DIETARY_SUPPLEMENTBL531_high dose
2.5×10\^10 cfu/day
DIETARY_SUPPLEMENTLR1349_low dose
1×10\^10 cfu/day
DIETARY_SUPPLEMENTLR1349_high dose
2.5×10\^10 cfu/day
Sponsors
Synbio Tech Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Computer Vision Syndrome Questionnaire (CVS-Q) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Surface Disease Index (OSDI) | 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. |
| Basic vision examination | 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. |
| Pupillary Response Test | 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. |
| Tear Secretion Assessment | 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. |
| Non-Invasive Tear Break-Up Time (NIBUT) | 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. |
| Corneal Tomography and Topography Analysis | 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. |
| Accommodative Function Assessment | 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. |
| Worth Four Dot Test | 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. |
Countries
Taiwan
Contacts
CONTACTHan-Yin Hsu
CONTACTChia-Chia Lee
Outcome results
None listed