Currently accepted at: JMIR Research Protocols
Date Submitted: Jan 8, 2026
Date Accepted: Feb 25, 2026
This paper has been accepted and is currently in production.
It will appear shortly on 10.2196/90893
The final accepted version (not copyedited yet) is in this tab.
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Effectiveness of low-dose atropine and combination with bright light therapy for controlling myopic eye growth in schoolchildren: study protocol for a randomised controlled trial
ABSTRACT
Background:
Myopia is increasingly prevalent worldwide, with projections indicating that nearly 50% of the global population may be myopic by 2050. This surge poses significant concerns due to its impact on vision, quality of life, and its link to a range of blinding diseases, including myopic macular degeneration, glaucoma, and retinal detachment. Current pharmacologic and optical interventions offer limited effectiveness in slowing myopia progression, highlighting the urgent need for more effective treatments. This study aims to examine the combined effect of bright light therapy and low-dose atropine on myopic progression.
Objective:
This trial aims to investigate whether the combination treatment of bright light therapy and low-dose atropine would be more effective than atropine alone.
Methods:
This is a single-site, two-arm, single-masked (examiner-masked), randomized controlled trial to compare the effectiveness of low-dose atropine alone and its combination with bright light therapy in retarding myopia progression. The study protocol is approved by the Institutional Review Boards of The Hong Kong Polytechnic University (HSEARS 20180829002-05) and The University of Hong Kong/Hospital Authority Hong Kong West Cluster (UW 20-362). Myopic schoolchildren with no previous myopic control interventions aged 7 to 12 years will be recruited and randomly allocated into two groups (n = 67 per group) after baseline measurements. Both groups will receive 0.01% atropine twice daily for 24 months. The combination treatment group will also receive a high-intensity lamp for bright light therapy. The primary and secondary outcome measures will be the changes in cycloplegic autorefraction in spherical equivalent refraction and axial length, respectively, measured every 6 months over two years from baseline.
Results:
The project was funded in January 2019. The recruitment process started on 21st March 2023 and was completed on 2nd February 2024. Data collection is expected to be completed in April 2026.
Conclusions:
This study will provide new information on whether the combination of bright light therapy and low-dose atropine is more effective than atropine alone in slowing slow myopia progression. It will also assess the effectiveness of low-dose atropine used twice daily. Combining bright light therapy and atropine could become a new treatment option if shown to be effective. New data on the effectiveness of using atropine twice daily might also expand available treatment options. Clinical Trial: The study is prospectively registered at ClinicalTrials.gov (identifier: NCT 04923841) on 11 June 2021.
Citation
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Copyright
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