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

NCT06589128 | Recruiting DMC

• 2 other identifiers: USM-Astaxanthin-02/2024R378
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Digital Eye Strain (DES)

Keywords

Children; Digital Eye Strain; Astaxanthin

Outcome Measures

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

  Baseline, 12 weeks and 24 weeks

Study Arms (2)

Astaxanthin

ACTIVE COMPARATOR

Oral astaxanthin supplement

Dietary Supplement: Astaxanthin Oral Capsule

Placebo

PLACEBO COMPARATOR

Oral placebo supplement

Dietary Supplement: Placebo

Interventions

Astaxanthin Oral Capsule DIETARY_SUPPLEMENT

Once daily supplementation of oral astaxanthin capsule for 24 weeks

Astaxanthin

Placebo DIETARY_SUPPLEMENT

Once daily supplementation of olive oil capsule for 24 weeks

Placebo

Eligibility Criteria

• Age: 10 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (2)

Universiti Sains Malaysia Bertam Medical Center

Kepala Batas, Pulau Pinang, 13200, Malaysia

RECRUITING

Universiti Sains Malaysia Bertam Medical Center

Kepala Batas, Pulau Pinang, 13200, Malaysia

RECRUITING

Related Publications (1)

• 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.

  PMID: 30691563 BACKGROUND

MeSH Terms

Interventions

astaxanthine

Study Officials

• Lai Kuan Dr., PhD

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lai Kuan Lee, PhD

CONTACT

6046536360; l.k.lee@usm.my

Bakiah Shaharuddin, MMed

CONTACT

bakiah@usm.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: October 25, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (2)