Randomized controlled trial2026

Three-Month Interim Analyses of Repeated Low-Level Red-Light Therapy in Myopia Control in Schoolchildren: A Pilot Multi-Ethnic Randomized Controlled Trial

Deen N, Zhu Z, Qi Z, Aung YY, Bulloch G, Miao D, He M

Ophthalmic epidemiology · 3 citations

How it was studied

Design
Randomized controlled trial (indexed by PubMed)
Studied in
People
Main outcome
Health markers and function

Who paid for it

Funding
Independent funding
Unclassified
Eyerising International

Based on 1 listed funder(s).

Publication

Published
2025-05-19 · Ophthalmic Epidemiol · vol. 33 · issue 3 · pp. 266–274
Publisher
Taylor & Francis
Cited
9 citations · more than 97% of similar papers · 5.6× the field average
Impact
Top 10% most cited in its field
References
26 works
Access
Paywalled
Research areas
Ophthalmology and Visual Impairment Studies · Corneal surgery and disorders · Retinopathy of Prematurity Studies
Keywords
Medicine, Interim, Ethnic group, Randomized controlled trial, Physical therapy, Optometry, Pediatrics, Internal medicine
MeSH
humans, myopia, disease progression, refraction, ocular, treatment outcome, phototherapy, follow-up studies, pilot projects, eyeglasses, visual acuity, adolescent, child, female, male, axial length, eye, ethnicity

7 authors

From AU, HK

  • Nelofar Deen · correspondingAustralian College of Optometry
  • Zhuoting Zhu
  • Ziyi QiAustralian College of Optometry
  • Yuri Yin‐Moe Aung
  • Gabriella BullochThe University of Melbourne
  • Di MiaoAustralian College of Optometry

Abstract

Purpose

To assess the efficacy and safety of repeated low-level red-light (RLRL) therapy in controlling myopia progression among multi-ethnic school-aged children. This report focuses on interim three-month data analysis.

Methods

A multi-ethnic, parallel controlled randomized trial. Thirty-four children aged 8-13 years with myopia were enrolled. Participants were randomly assigned to the RLRL group (n = 17) or the single-vision spectacles (SVS) control group (n = 17). RLRL therapy was administered twice daily on weekdays for three-minute sessions, while the SVS group continued routine activities. Assessments were scheduled at baseline and follow-up visits at one, three, six and 12 months, with compliance monitoring and safety assessments throughout. Respectively the primary outcome and a key secondary outcome are axial length (AL) change and cycloplegic spherical equivalent (SE) change.

Results

A total of 32 (94.1%) participated in the three-month follow-up visit. The RLRL group demonstrated a significant shortening in AL ( - 0.06 ± 0.05 mm) compared to the SVS group (0.02 ± 0.06 mm, p < 0.001). Similarly, the RLRL group demonstrated a reversal in SE (0.23 ± 0.18 D), whereas the SVS group exhibited a smaller increase (0.04 ± 0.43 D). No severe adverse events were reported in either of the groups.

Conclusions

The three-month interim analysis shows that RLRL therapy effectively controls myopia progression among multi-ethnic children without safety concerns, suggesting its potential as a globally applicable solution for myopia control.

Abstract via Europe PMC. Copyright remains with the authors or publisher.

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