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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-11
SponsorUniversiti Sains Malaysia

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Astaxanthin Oral Capsule

    Dietary supplement

    Once daily supplementation of oral astaxanthin capsule for 24 weeks

  • Placebo

    Dietary supplement

    Once daily supplementation of olive oil capsule for 24 weeks

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: AstaxanthinActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame
Baseline, 12 weeks and 24 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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