CClinicalTrials.gg
CompletedNCT04923841Updated May 12, 2026

Myopia Control Using Bright Light Therapy, Myopic Defocus and Atropine

An interventional study of High intensity light box for bright light therapy and single vision spectacle lenses and High intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses in Myopia, sponsored by The Hong Kong Polytechnic University. Completed at 1 site in Hong Kong. Open to participants aged 7 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
577
Allocation
Randomized
Ages
7 Years to 12 Years
Sex
All
01

Study summary

The purpose of the study is to investigate the effect of bright light therapy, myopic defocus, atropine and the combination in myopia control in schoolchildren.

Read the detailed description

The present study is a multi-arm randomised clinical trial with a 24-month duration. Subjects will be healthy Hong Kong Chinese schoolchildren with low to moderate myopia. The aims are to determine the clinical effectiveness of bright light therapy on inhibiting myopia progression in schoolchildren, and to determine whether combination therapy using bright light therapy (BLT) and myopic defocus is more effective than monotherapy.

Study population Seven hundred and sixty Hong Kong Chinese children (152 in each) of A. Control group, B. BLT only group, C. BLT and Defocus Incorporated Multiple Segments (DIMS) group, D. BLT and atropine 0.01% group) and E. Atropine 0.01% group aged 7-12 years old will be recruited. They must not have had prior or current myopia control treatment, have no ocular or systemic diseases/abnormalities that affect visual function, refractive development or spectacle lens wear, and no previous intraocular or corneal surgery. They must not have allergy to atropine.

The eligible subjects will be randomly assigned into one of the four groups. Their cycloplegic refraction and axial length will be monitored every six months for 2 years. The changes in refractive errors and axial length between groups will be compared.

02

Conditions studied

  • Myopia

Browse trials for

Keywords

  • Myopia control
  • Bright light
  • Myopic defocus
  • Atropine
03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 577 is above the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

The Hong Kong Polytechnic University is the lead sponsor of 659 studies on the registry; 250 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Myopia of at least -0.75D (spherical equivalent) in both eyes
  • Age at enrolment: 7-12 year; Hong Kong Chinese
  • Astigmatism and anisometropia: 1.50D or less
  • Spectacle corrected monocular visual acuity (VA): 0.0 logMAR or better
  • Parents' understanding and acceptance of random allocation of grouping and masking
  • Able to wear the prescribed spectacle, put on eye drop and undergo light therapy daily.

Exclusion criteria

Exclusion Criteria:

  • Eye disease or binocular vision problems (e.g., strabismus, amblyopia, oculomotor nerve palsies, corneal disease, etc.)
  • Previous intraocular or corneal surgery
  • Systemic disease that may affect vision, vision development (e.g. endocrine, cardiac and respiratory diseases, diabetes, Down syndrome, etc.)
  • Allergy to atropine
  • Previous gas permeable, soft bifocal, or orthokeratology contact lens wear or bifocal/PAL/specific myopic control spectacle wear or use of atropine or pirenzepine (longer than 1 month of wear)
  • Previous or current participation in myopia control studies
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
577 participants (actual)

Study arms

  • No intervention
    Control

    Subjects in control will receive single vision spectacle lenses and a placebo desk lamp

  • Experimental
    BLT monotherapy

    Subjects in BLT monotherapy group will receive a high intensity light box for bright light therapy and single vision spectacle lenses

    Other: High intensity light box for bright light therapy and single vision spectacle lenses

  • Experimental
    BLT and DIMS

    Subjects in BLT and DIMS group will receive a high intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses

    Other: High intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses

  • Experimental
    BLT and atropine

    Subjects in BLT and atropine group will receive a high intensity light box for bright light therapy, single vision spectacle lens, and atropine 0.01% eye drop (twice a day)

    Other: High intensity light box for bright light therapy and atropine 0.01% eye drop and and single vision spectacle lenses

  • Experimental
    Atropine monotherapy

    Subjects in atropine group will receive atropine 0.01% eye drop (twice a day) and single vision spectacle lenses

    Other: Atropine 0.01% eye drop and and single vision spectacle lenses

Interventions

  • OtherHigh intensity light box for bright light therapy and single vision spectacle lenses

    High intensity light box for bright light therapy and single vision spectacle lenses

  • OtherHigh intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses

    High intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses

  • OtherHigh intensity light box for bright light therapy and atropine 0.01% eye drop and and single vision spectacle lenses

    High intensity light box for bright light therapy and atropine 0.01% eye drop and and single vision spectacle lenses

  • OtherAtropine 0.01% eye drop and and single vision spectacle lenses

    Atropine 0.01% eye drop and and single vision spectacle lenses

06

What researchers measure

Primary outcomes

  1. Cycloplegic Refraction Change in spherical equivalent refraction (SER)

    Change in cycloplegic SER (in diopter) will be measured using an open field autorefractor

    Time frame: Baseline and 2 years

Secondary outcomes

  1. Axial length

    Axial length (mm) will be measured after cycloplegia using a non-contact optical biometer

    Time frame: Baseline and 2 years

07

Study locations

1 site
  • Centre for Myopia Research, The Hong Kong Polytechnic University and Department of Ophthalmology, The University of Hong Kong
    Hong Kong, No postcode, Hong Kong
08

References and documents

Publications

  • Hon Y, Chun RKM, Cheung BKK, Lam DMK, Kong ACW, Ho LM, Lam WC, Lam TC, Lam CS, Lian J, Morgan IG, To CH, Leung CKS, Tse DY. Effectiveness of bright light therapy and combination with myopic defocus for controlling myopic eye growth in schoolchildren: study protocol for a randomised controlled trial (phase 1). BMJ Open Ophthalmol. 2025 May 19;10(1):e002044. doi: 10.1136/bmjophth-2024-002044. PubMed 40389302 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04923841
Lead sponsor
The Hong Kong Polytechnic University
Collaborators
The University of Hong Kong
Responsible party
Sponsor
First posted
Jun 11, 2021
Start date
Sep 9, 2021
Primary completion
Mar 17, 2026
Completion
Mar 17, 2026
Last update
May 12, 2026

Study contacts

Chi Ho To, PhD
principal investigator · School of Optometry, The Hong Kong Polytechnic University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion