RecruitingNot Applicable

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

Malaysia70 participantsStarted 2024-10-01

Plain-language 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 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.

Who can participate

Age range

10 Years – 11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1My child may have digital eye strain — could you look at their Computer Vision Syndrome Questionnaire score with me and explain what it means for whether this kind of trial might even be relevant for them?
2Since this trial is listed as 'Phase NA,' what does that tell us about how much is already known about the safety and effectiveness of the investigator product being tested in children?
3How would you compare joining this trial to just making practical changes like screen-time limits or using existing eye drops — is there a reason to consider a study like this before trying those options first?
4What would my child actually need to do during this trial, and how might the visit schedule or testing requirements fit around school and daily life?
5If my child's symptoms don't improve — or get worse — during the trial, what would the process be for stopping participation and switching to a standard treatment?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Computer Vision Syndrome-Questionnaire score

Timeframe: Baseline, 12 weeks and 24 weeks

Trial details

NCT IDNCT06589128

SponsorUniversiti Sains Malaysia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-25

Contact for this trial

Lai Kuan Lee, PhD

6046536360 l.k.lee@usm.my

View on ClinicalTrials.gov More Digital Eye Strain (DES) trials