MyopiaNCT04923841
Myopia Control Using Bright Light Therapy, Myopic Defocus and Atropine
A study testing High intensity light box for bright light therapy and single vision spectacle lenses, High intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses and High intensity light box for bright light therapy and atropine 0.01% eye drop and and single vision spectacle lenses in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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 more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- High intensity light box for bright light therapy and single vision spectacle lenses, High intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses and High intensity light box for bright light therapy and atropine 0.01% eye drop and and single vision spectacle lenses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 577 participants
- Where
- 1 siteHong Kong
- Study dates
- 9 Sep 2021to 17 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Centre for Myopia Research, The Hong Kong Polytechnic University and Department of Ophthalmology, The University of Hong Kong
Hong Kong, No postcode
About this study
Official title: Effectiveness of Bright Light Therapy, Myopic Defocus, Atropine and the Combinations for Controlling Myopic Eye Growth in Schoolchildren: A Randomized Control Trial
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.
- Conditions
- Myopia
- Being tested
- High intensity light box for bright light therapy and single vision spectacle lenses, High intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses, High intensity light box for bright light therapy and atropine 0.01% eye drop and and single vision spectacle lenses, Atropine 0.01% eye drop and and single vision spectacle lenses
- Keywords
- Myopia control, Bright light, Myopic defocus, Atropine
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity light box for bright light therapy and single vision spectacle lensesOther
High intensity light box for bright light therapy and single vision spectacle lenses
High intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lensesOther
High intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses
High intensity light box for bright light therapy and atropine 0.01% eye drop and and single vision spectacle lensesOther
High intensity light box for bright light therapy and atropine 0.01% eye drop and and single vision spectacle lenses
Atropine 0.01% eye drop and and single vision spectacle lensesOther
Atropine 0.01% eye drop and and single vision spectacle lenses
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Subjects in control will receive single vision spectacle lenses and a placebo desk lamp |
| BLT monotherapy | Experimental | Subjects in BLT monotherapy group will receive a high intensity light box for bright light therapy and single vision spectacle lenses Receives: Other: High intensity light box for bright light therapy and single vision spectacle lenses |
| BLT and DIMS | Experimental | 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 Receives: Other: High intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses |
| BLT and atropine | Experimental | 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) Receives: Other: High intensity light box for bright light therapy and atropine 0.01% eye drop and and single vision spectacle lenses |
| Atropine monotherapy | Experimental | Subjects in atropine group will receive atropine 0.01% eye drop (twice a day) and single vision spectacle lenses Receives: Other: Atropine 0.01% eye drop and and single vision spectacle lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cycloplegic Refraction Change in spherical equivalent refraction (SER)
Change in cycloplegic SER (in diopter) will be measured using an open field autorefractor
Measured: Baseline and 2 years
Secondary outcomes (1)
Axial length
Axial length (mm) will be measured after cycloplegia using a non-contact optical biometer
Measured: Baseline and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start9 Sep 2021
- Primary completion17 Mar 2026
- Study completion17 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 577 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong
- Responsible party
- Sponsor
- Investigators
- Chi Ho To, PhD, Principal investigator, School of Optometry, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923841
- Sponsor's protocol ID
- R5032-18
- Status last verified
- Apr 2026
- First submitted
- 7 Jun 2021
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tse DY, Ma MM, Hon Y, Ho LM, Lam WC, Shih KC, Zhang X, Lam DMK, Kong ACW, Lam TC, Lam CSY, Lian TJ, Morgan I, To CH, Chun RKM, Leung CKS. Effectiveness of Low-Dose Atropine Combined With Bright Light Therapy for Controlling Myopic Eye Growth in Schoolchildren: Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Apr 13;15:e90893. doi: 10.2196/90893.
PubMed 41973601Hon 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
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Bright Light Therapy, Myopic Defocus, Atropine and the Combinations for Controlling Myopic Eye Growth in Schoolchildren: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04923841
- Acronym / sponsor ID
- R5032-18
- Conditions
- Myopia
- Keywords
- Myopia control, Bright light, Myopic defocus, Atropine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 577 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- The University of Hong Kong
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 17 Mar 2026 (actual)
- Study completion
- 17 Mar 2026 (actual)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Subjects in control will receive single vision spectacle lenses and a placebo desk lamp |
| BLT monotherapy | Experimental | Other: High intensity light box for bright light therapy and single vision spectacle lensesSubjects in BLT monotherapy group will receive a high intensity light box for bright light therapy and single vision spectacle lenses |
| BLT and DIMS | Experimental | Other: High intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lensesSubjects in BLT and DIMS group will receive a high intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses |
| BLT and atropine | Experimental | Other: High intensity light box for bright light therapy and atropine 0.01% eye drop and and single vision spectacle lensesSubjects 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) |
| Atropine monotherapy | Experimental | Other: Atropine 0.01% eye drop and and single vision spectacle lensesSubjects in atropine group will receive atropine 0.01% eye drop (twice a day) and single vision spectacle lenses |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity light box for bright light therapy and single vision spectacle lensesHigh intensity light box for bright light therapy and single vision spectacle lenses | Other | BLT monotherapy |
| High intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lensesHigh intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses | Other | BLT and DIMS |
| High intensity light box for bright light therapy and atropine 0.01% eye drop and and single vision spectacle lensesHigh intensity light box for bright light therapy and atropine 0.01% eye drop and and single vision spectacle lenses | Other | BLT and atropine |
| Atropine 0.01% eye drop and and single vision spectacle lensesAtropine 0.01% eye drop and and single vision spectacle lenses | Other | Atropine monotherapy |
Primary outcome
Cycloplegic Refraction Change in spherical equivalent refraction (SER)
Time frame: Baseline and 2 years
Change in cycloplegic SER (in diopter) will be measured using an open field autorefractor
1 secondary outcome
Axial length
Time frame: Baseline and 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Derived from this study: PubMed 41973601Tse DY, Ma MM, Hon Y, Ho LM, Lam WC, Shih KC, Zhang X, Lam DMK, Kong ACW, Lam TC, Lam CSY, Lian TJ, Morgan I, To CH, Chun RKM, Leung CKS. Effectiveness of Low-Dose Atropine Combined With Bright Light Therapy for Controlling Myopic Eye Growth in Schoolchildren: Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Apr 13;15:e90893. doi: 10.2196/90893.
- Derived from this study: PubMed 40389302Hon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi Ho To, PhD principal investigator
School of Optometry, The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity light box for bright light therapy and single vision spectacle lenses, High intensity light box for bright light therapy and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses and High intensity light box for bright light therapy and atropine 0.01% eye drop and and single vision spectacle lenses in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cycloplegic Refraction Change in spherical equivalent refraction (SER) (time frame: Baseline and 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04923841, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.