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RecruitingNot ApplicableNCT06589128

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

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

Sponsor

Universiti Sains Malaysia

Enrollment

70 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Digital Eye Strain (DES)

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.

Eligibility

Min Age: 10 YearsMax Age: 11 Years

Inclusion Criteria1

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

Exclusion Criteria16

  • 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

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Interventions

DIETARY_SUPPLEMENTAstaxanthin Oral Capsule

Once daily supplementation of oral astaxanthin capsule for 24 weeks

DIETARY_SUPPLEMENTPlacebo

Once daily supplementation of olive oil capsule for 24 weeks

Locations(2)

Universiti Sains Malaysia Bertam Medical Center

Kepala Batas, Pulau Pinang, Malaysia

Universiti Sains Malaysia Bertam Medical Center

Kepala Batas, Pulau Pinang, Malaysia

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NCT06589128