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Randomized Controlled Trial
. 2025 Apr;42(4):1811-1833.
doi: 10.1007/s12325-025-03125-7. Epub 2025 Feb 27.

Astaxanthin (AstaReal®) Improved Acute and Chronic Digital Eye Strain in Children: A Randomized Double-Blind Placebo-Controlled Trial

Karen A Hecht #  1 , Megha Marwah #  2 , Vincent Wood  3 , Yasuhiro Nishida  4 , Austin E Bach  5 , Jeffry Gerson  6 , Milton M Hom  7 , Joerg Schnackenberg  8 , Sonal Raote  9 , Shalini Srivastava  9 , Pankaj Negi  2 , Eric Caston  8
Affiliations
Randomized Controlled Trial

Astaxanthin (AstaReal®) Improved Acute and Chronic Digital Eye Strain in Children: A Randomized Double-Blind Placebo-Controlled Trial

Karen A Hecht et al. Adv Ther. 2025 Apr.

Abstract

Introduction: This study assessed the effects of astaxanthin supplementation on chronic and acute digital eye strain in school-aged children (10-14 years) and evaluated its safety. While previous studies focused on adults, this study examined astaxanthin's effects on developing eyes.

Methods: A randomized, double-blind, placebo-controlled trial was conducted over 84 days involving 64 children engaged in ≥ 4 h of screen time daily and experiencing mild to moderate computer vision syndrome (CVS) symptoms as indicated by a CVS-Questionnaire (CVS-Q) score ≥ 8 and < 19. Participants received a daily 4-mg astaxanthin soft capsule for 84 days. Primary outcomes were measured using CVS-Q, while secondary outcomes included visual fatigue Likert scale (VFLS), visual acuity, spherical equivalence, near point of accommodation, near exophoria, dry eye intensity, pupil size, stereopsis, blinking frequency, immunity, and safety variables.

Results: Of the 64 participants (mean age 11.5-11.7 years), 35 were male and 29 were female. Astaxanthin supplementation significantly improved CVS-Q scores after 84 days (- 4.00 ± 4.05 arbitrary units (A.U.) from baseline, p < 0.0001) compared to placebo (- 1.72 ± 3.61 A.U., p < 0.05), a 20% between group difference. The mean VFLS scores were significantly lower in the astaxanthin group (11.55 ± 5.78 A.U.) compared to placebo (15.78 ± 7.12 A.U., p = 0.01), showing a 27% improvement after 84 days. Stereopsis improved significantly after acute visual load at 28 and 84 days (p < 0.05, p < 0.0001 vs. placebo, respectively), and pupillary light reflex improved after 84 days (p < 0.05 vs. placebo). Tear production increased after 14, 56, and 84 days (p < 0.05, p < 0.001, and p < 0.001 vs. baseline, respectively) in the astaxanthin group, with no significant intergroup difference in the Schirmer I test, visual acuity, spherical equivalence, near point of accommodation, near exphoria, immune markers, or safety variables.

Conclusion: Astaxanthin supplementation effectively reduced chronic and acute digital eye strain, while enhancing objective measures of visual performance in school-aged children, underscoring the benefits of astaxanthin in pediatric visual health and performance.

Trial registration: NIH ClinicalTrials.gov (Identifier: NCT05602402); Clinical Trials Registry India (Registration Number: CTRI/2022/10/046606).

Keywords: Antioxidant supplement; Astaxanthin; Asthenopia; Children; Computer vision syndrome; Digital device usage; Dry eyes; Eye strain; Ocular nutrition.

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Conflict of interest statement

Declarations. Conflict of Interest: Eric Caston and Yasuhiro Nishida are employed by Fuji Chemical Industries Co. Ltd., Japan (Fuji). Pankaj Negi and Megha Marwah are employed by AstaReal India Pvt. Ltd, Karen A. Hecht is employed by AstaReal Inc. and Vincent Wood is employed by AstaReal Singapore Pte Ltd, which are subsidiaries of Fuji. Austin E. Bach, Jeffry Gerson and Milton M. Hom have nothing to disclose. Joerg Schnackenberg was an employee of Fuji at the time the study was initiated. He is now affiliated with NIRx Medical Technologies, Tokorozawa, Japan. Sonal Raote and Shalini Srivastava are employed by Vedic Lifesciences, a contract research organization engaged by Fuji. Ethical Approval: The study was approved and monitored by the Institutional Ethics Committee at four centers included in this trial in India (Jaipur National University Institute for Medical Sciences and Research Centre [ECR/905/Inst/RJ/2017/RR-20], Rajasthan; Institutional Ethics Committee Aman Hospital & Research Centre [ECR/857/Inst/GJ/2016/RR-19], Gujarat; Harmony Ethical Research Committee (HERC) Shree Hospital [ECR/1411/Inst/MH/2020], Mumbai; Maharashtra and Muktai Ethics Committee [ECR/251/Inst/Maha/2013/RR-19], Nashik, Maharashtra). It was conducted in compliance with the Declaration of Helsinki, International Conference on Harmonization (ICH) recommendation on Good Clinical Practice (GCP)—E6 (R2), 2016, and National Ethical Guidelines for Biomedical and Health Research involving Human Participants, 2017 issued by Indian Council of Medical Research (ICMR), India. The study was registered on ClinicalTrials.gov (NCT05602402) and the Clinical Trials Registry India (CTRI/2022/10/046606). For participants below 12 years, consent was through parents alone, while for those between 12 and 14 years, both parents and participants provided consent. All participants provided informed consent for the anonymous use of their data in scientific analyses and publications, following a detailed explanation of the study.

References

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