AzTrials
AzTrials

Digital Eye Strain (DES)DESNCT06589128

Efficacy of Investigator Product for the Amelioration of Digital Eye Strain in Children

A study testing Astaxanthin Oral Capsule in people with Digital Eye Strain (DES), run by Universiti Sains Malaysia at 2 sites in Malaysia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Computer vision syndrome (CVS), also referred to as Digital eye strain (DES), is a group of eye and vision problems caused by prolonged use of electronic devices. The American Optometric Association (APA) defines DES as a group of eye and vision-related problems caused by prolonged computer, tablet, e-reader, and cell… Read more about this study

Who is it for?
Ages 10 to 11 years
Conditions the study is for
Digital Eye Strain (DES)
What is being tested?
Astaxanthin Oral Capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
2 sitesMalaysia
Study dates
1 Oct 2024to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children with DES (CVS-Q score 6-18)

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lai Kuan Lee, PhD contact

6046536360

l.k.lee@usm.my

Bakiah Shaharuddin, MMed contact

bakiah@usm.my

Malaysia2 sites, 2 recruiting
  • Universiti Sains Malaysia Bertam Medical Center

    Kepala Batas, Pulau Pinang, 13200

    Lai Kuan Dr. Lee, PhD, +6046536360, l.k.lee@usm.my

    Bakiah Dr. Shaharuddin, MMed, +60104020301, bakiah@usm.my

    Recruiting
  • Universiti Sains Malaysia Bertam Medical Center

    Kepala Batas, Pulau Pinang, 13200

    Lai Kuan Dr., PhD, +604-6536360, l.k.lee@usm.my

    Bakiah Assoc. Prof. Dr., MMed, +604-562 2888, bakiah@usm.my

    Recruiting

Other trials in Malaysia

About this study

Official title: Efficacy of Investigator Product for the Amelioration of Digital Eye Strain in Children: a Randomized, Double-blind, Placebo-controlled Human Clinical Trial

Computer vision syndrome (CVS), also referred to as Digital eye strain (DES), is a group of eye and vision problems caused by prolonged use of electronic devices. The American Optometric Association (APA) defines DES as a group of eye and vision-related problems caused by prolonged computer, tablet, e-reader, and cell phone use. Currently, for more than 20 years, DES has been recognised as a public health issue, and the terms DES are also used to describe the condition, attributed to the wide range of digital devices associated with potential problems.

Read the detailed description

Digital device usage has increased substantially in recent years across all age groups, so that extensive daily use for both social and professional purposes is now normal. Digital eye strain (DES), also known as computer vision syndrome, encompasses a range of ocular and visual symptoms, and estimates suggest its prevalence may be 50% or more among computer users. Symptoms fall into two main categories: those linked to accommodative or binocular vision stress, and external symptoms linked to dry eye. Although symptoms are typically transient, they may be frequent and persistent, and have an economic impact when vocational computer users are affected.

Astaxanthin is a naturally occurring red carotenoid pigment belonging to the family of xanthophylls, and is typically found in marine environments, especially in microalgae and seafood such as salmonids, shrimps and lobsters. Application fields of astaxanthin range from the food coloring industry, for its natural intense red color brightness, to aquaculture and poultry industries for its natural feed addictive properties. Due to its unique molecular structure, astaxanthin features some important biologic properties, mostly represented by strong antioxidant, anti-inflammatory and antiapoptotic activities. A growing body of evidence suggests that astaxanthin is efficacious in the prevention and treatment of several ocular diseases, ranging from the anterior to the posterior pole of the eye. In particular, astaxanthin seems to be effective in improving blood capillary circulation of the eyes. In Japan, human clinical trial showed that consuming 9mg of astaxanthin daily over four weeks significantly improved the eyes' ability to accommodate different focuses and reduce eye strain, hazy vision, flickering images, shoulder or back stiffness as compared to the control group. Astaxanthin has been reported to have an ocular accommodation improvement effect, and acts as a substance to help with asthenopia recovery and could contribute to the improvement of blood circulation in peripheral systems. Due to the well-known effects of helping 2 eyes in many ocular structures, astaxanthin is a superlative bodyguard to prevent smartphone eye damages.

DES is the most common eye problem associated with prolonged digital device use, characterized by symptoms such as dry eyes, itching, foreign body sensation, watering, blurring of vision, and headaches. It is increasingly common for present day children have grown up with electronic devices and this has become the norm in many of the more affluent societies. Some caregivers may even use such electronic technology as an "electronic pacifier" to calm and entertain their kids. Digital technology always raises concerns about a potential negative impact on the physical, cognitive, emotion and social well-being of the children. There is evidence that excessive screen time is associated with a variety of health harms among children, with evidence strongest for an unhealthy diet, adiposity, depressive symptoms and quality of life.

DES in children is of particular concerning, as it does not have any suggested medical treatment to ameliorate the symptoms. The role of nutrition as complementary medicine is getting scientific attention nowadays. Astaxanthin, a potent antioxidant classified under the red-pigment carotenoid, is a promising vision enhancer with numerous human clinical trial evidences conducted among the adults. However, limited research has been conducted to determine the effect of astaxanthin supplementation among the children with DES. As DES in children is of utmost concern, the current study aims to investigate whether dietary supplementation with astaxanthin could (1) ameliorate the DES symptoms; (2) improve the blue light exposure-associated health complaints; (3) improve the cognitive function and quality of life among the school age children.

Being tested
Astaxanthin Oral Capsule, Placebo
Keywords
Children, Digital Eye Strain, Astaxanthin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Astaxanthin Oral CapsuleDietary supplement

    Once daily supplementation of oral astaxanthin capsule for 24 weeks

  • PlaceboDietary supplement

    Once daily supplementation of olive oil capsule for 24 weeks

Study groups in NCT06589128
Study groupRoleWhat they receive
AstaxanthinActive comparatorOral astaxanthin supplement
Receives: Dietary Supplement: Astaxanthin Oral Capsule
PlaceboPlacebo comparatorOral placebo supplement
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Computer Vision Syndrome-Questionnaire score

    Higher scores mean a worse outcome. The minimum score is 0, while the maximum score is 32

    Measured: Baseline, 12 weeks and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start1 Oct 2024
  3. Primary completion25 Oct 2025
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06589128
Sponsor's protocol ID
USM-Astaxanthin-02/2024
Other IDs
R378
Acronym
DES
Status last verified
Apr 2026
First submitted
5 Sep 2024
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Participants are children and they are categorized as vulnerable group.

Publications

  • Chawla A, Lim TC, Shikhare SN, Munk PL, Peh WCG. Computer Vision Syndrome: Darkness Under the Shadow of Light. Can Assoc Radiol J. 2019 Feb;70(1):5-9. doi: 10.1016/j.carj.2018.10.005.

    PubMed 30691563

Questions about this trial

What is this clinical trial studying?

A study testing Astaxanthin Oral Capsule in people with Digital Eye Strain (DES), run by Universiti Sains Malaysia at 2 sites in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lai Kuan Lee, PhD (6046536360, l.k.lee@usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Computer Vision Syndrome-Questionnaire score (time frame: Baseline, 12 weeks and 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06589128, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in