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.
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.
Bakiah Shaharuddin, MMed contact
Malaysia2 sites, 2 recruiting
- 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
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.
- Conditions
- Digital Eye Strain (DES)
- 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 group | Role | What they receive |
|---|---|---|
| Astaxanthin | Active comparator | Oral astaxanthin supplement Receives: Dietary Supplement: Astaxanthin Oral Capsule |
| Placebo | Placebo comparator | Oral placebo supplement Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted19 Sep 2024
- Study start1 Oct 2024
- Primary completion25 Oct 2025
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Digital Eye Strain (DES)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Lee Lai Kuan, Universiti Sains Malaysia
- Investigators
- Lai Kuan Dr., PhD, Principal investigator, Universiti Sains Malaysia
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Investigator Product for the Amelioration of Digital Eye Strain in Children: a Randomized, Double-blind, Placebo-controlled Human Clinical Trial
- ClinicalTrials.gov ID
- NCT06589128
- Acronym / sponsor ID
- DES / USM-Astaxanthin-02/2024
- Conditions
- Digital Eye Strain (DES)
- Keywords
- Children, Digital Eye Strain, Astaxanthin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 25 Oct 2025 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Astaxanthin | Active comparator | Dietary Supplement: Astaxanthin Oral CapsuleOral astaxanthin supplement |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOral placebo supplement |
Who may qualify
- Ages
- 10 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with DES (CVS-Q score 6-18)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Astaxanthin Oral CapsuleOnce daily supplementation of oral astaxanthin capsule for 24 weeks | Dietary supplement | Astaxanthin |
| PlaceboOnce daily supplementation of olive oil capsule for 24 weeks | Dietary supplement | Placebo |
Primary outcome
Change in Computer Vision Syndrome-Questionnaire score
Time frame: Baseline, 12 weeks and 24 weeks
Higher scores mean a worse outcome. The minimum score is 0, while the maximum score is 32
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 30691563Chawla 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.
- Individual participant dataSharing planned: No. Participants are children and they are categorized as vulnerable group.
Related trials for Digital Eye Strain (DES)
Recruiting
Lactic Acid Bacteria for Reducing Blue Light-Induced Eye Fatigue
Digital Eye Strain (DES)
Not yet recruiting
Study of Eye Fatigue From Digital Screens and Its Impact on Visual Performance in People With Normal Vision and Myopia, With and Without Dry Eye Symptoms and Signs
Myopia, Dry Eye Disease (DED)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bakiah Shaharuddin, MMed contact
Lai Kuan Dr., PhD principal investigator
Universiti Sains Malaysia
2 sites in 1 country: see every site and its status.
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.