Astaxanthin to ease digital eye strain in children
Official title: Efficacy of Investigator Product for the Amelioration of Digital Eye Strain in Children: a Randomized, Double-blind, Placebo-controlled Human Clinical Trial
Run by Universiti Sains Malaysia · NCT06589128 · Data updated 2026-11-12
This test will see if an oral astaxanthin capsule can reduce digital eye strain symptoms in children who use electronic devices.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 10 Years to 11 Years |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Universiti Sains Malaysia Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Kepala Batas, Pulau Pinang and 1 other locations) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | October 25, 2025 |
| Study ends | June 30, 2026 |
| Registry record updated | April 29, 2026 |
| Trial ID | NCT06589128 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children who have digital eye strain with CVS-Q scores between 6 and 18 and who do not meet any exclusion criteria (for example, no contact lens use, no diagnosed binocular/accommodative disorders, and no relevant systemic illnesses) are ideal candidates.
✕Probably not a fit
Children with severe digital eye strain (CVS-Q ≥19), contact lens wearers, those with ocular motility or accommodative/binocular vision disorders, or those taking carotenoid/retinol supplements are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Children with mild-to-moderate digital eye strain (CVS-Q score 6–18) are enrolled and receive either an oral astaxanthin capsule or a matching placebo while being followed for changes in symptoms. Symptom severity is tracked with validated questionnaires (CVS-Q) and eye examinations to monitor signs such as dry eye and accommodative strain. The protocol excludes children with severe DES, contact lens use, ocular motility or binocular disorders, recent ocular procedures, systemic diseases affecting the eye, and use of carotenoid/retinol supplements. Safety and tolerability of the oral astaxanthin product are monitored throughout the treatment period.
Why it matters
Potential benefit: If successful, the treatment could reduce the frequency and severity of screen-related eye discomfort in children, improving comfort during device use.
How similar studies have gone: Some adult and preclinical research suggests astaxanthin's antioxidant and anti-inflammatory properties may help ocular symptoms, but randomized pediatric data are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children with DES (CVS-Q score 6-18) Exclusion Criteria: * Children with CVS-Q score ≥ 19 * Children who wear contact lenses * Children with any diagnosed ocular motility disorder or accommodative/binocular vision issues * Participants who are colour-blind * Participant on any retinols and carotenoid supplements * Participants who have immunosuppressive disorders or are taking immunosuppressive medication * Atopy, allergic disorders * Anaemia * Ophthalmic laser treatment (less than 3 months) * Systemic disease associated with dry eye * Blepharitis * Having liver (chronic liver failure, cirrhosis, all types of hepatitis), kidney (chronic kidney disease, haemodialysis) or haematological (anaemia, thalassemia, haemophilia) disorders * Psychiatric disease/mental retardation (bipolar disorder, depression, schizophrenia) * Cancer (all types), and endocrine disorders (Cushing's disease, gigantism and hyperthyroidism) * Use of steroids, chemotherapy or radiotherapy * Currently under another supplementary program
Where it's running
-
Universiti Sains Malaysia Bertam Medical Center
Kepala Batas, Pulau Pinang, Malaysia Recruiting -
Universiti Sains Malaysia Bertam Medical Center
Kepala Batas, Pulau Pinang, Malaysia Recruiting
Study contacts
- Principal investigator: Lai Kuan Dr., PhD — Universiti Sains Malaysia
- Study coordinator: Lai Kuan Lee, PhD
- Email: l.k.lee@usm.my
- Phone: 6046536360
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.