MyopiaNCT06358755
Combination Effect of Optical Defocus and Low Dose Atropine in Myopia Control
A study testing Defocus Incorporated Multiple Segments lenses, single vision spectacle lenses and Low dose atropine 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 combination effect of optical defocus and low dose atropine on 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?
- Defocus Incorporated Multiple Segments lenses, single vision spectacle lenses and Low dose atropine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteHong Kong
- Study dates
- 12 Jul 2024to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age at enrollment: 7 to 12 years
- Ethnicity: Hong Kong Chinese
- Myopia: -0.75D (in spherical equivalent) or above in both eyes
- Astigmatism: -1.50D or less in both eyes
- Anisometropia: 1.50D or less (in spherical equivalent) between two eyes
- Best corrected monocular visual acuity (VA): 0.04 logMAR or better
Show all 13Show fewer
- Ocular health: No abnormalities in both internal and external ocular health
- Systemic health: No abnormalities such as cardiac and respiratory diseases
- Binocular vision: No strabismus, diplopia, suppression and other binocular abnormalities
- Normal colour vision
- No previous refractive surgery or use of myopic control interventions, such as atropine, orthokeratology, and specialized spectacle lenses and contact lenses for myopic control
- Able to wear the prescribed spectacles
- No known allergy to atropine
Who cannot join
- Eye disease or binocular vision problems (e.g., strabismus, amblyopia, oculomotor nerve palsies, corneal disease, etc.)
- Previous intraocular or corneal surgery
- Colour vision deficiencies
- Systemic disease that may affect vision, vision development (e.g. diabetes mellitus, hypertension, Down syndrome, etc.)
- Systemic disease that are contradictory to atropine (e.g. asthma, cardiac diseases, etc.)
- Previous gas permeable, soft bifocal, or orthokeratology contact lenses wear or bifocal / progressive addition lens spectacles wear or use of atropine or pirenzepine (longer than one month of usage)
- Previous or current participation in myopia control studies
- Allergy to cyclopentolate hydrochloride or atropine
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: Combination Effect of Optical Defocus and Low Dose Atropine in Myopia Control - a Randomized Clinical Trial
The purpose of the study is to investigate the combination effect of optical defocus and low dose atropine on myopia control in schoolchildren.
Read the detailed description
This study is a two-arm randomised controlled trial with a 18-month duration. Participants will be healthy Hong Kong Chinese schoolchildren with low to moderate myopia. The aim is to determine the combination effect of optical defocus and low dose atropine on myopia control in schoolchildren. Optical defocus will be delivered by Defocus Incorporated Multiple Segments (DIMS) spectacle lenses.
A total of 112 Hong Kong Chinese children aged 7 to 12 years (56 in each group) will be recruited and randomly allocated into two groups. One group will receive low dose atropine (0.01%) plus DIMS spectacles (ATD Group); another one will receive low dose atropine (0.01%) plus single vision spectacles (AT Group).
They must have no 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.
Their cycloplegic refraction and axial length will be monitored every six months for 18 months. The changes in refractive errors and axial length between groups will be compared.
- Conditions
- Myopia
- Being tested
- Defocus Incorporated Multiple Segments lenses, single vision spectacle lenses, Low dose atropine
- Keywords
- Myopia control, 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.
Defocus Incorporated Multiple Segments lensesDevice
Defocus Incorporated Multiple Segments lenses that provide optical defocus for myopia control will be given to this group of participants.
single vision spectacle lensesDevice
Single vision spectacle lenses will be given to this group of participants.
Low dose atropineDrug
0.01% atropine administrated twice per day (1 drop in the morning and 1 drop at night before bedtime) will be given as intervention.
| Study group | Role | What they receive |
|---|---|---|
| Low dose atropine plus DIMS | Experimental | This group will receive 0.01% atropine (twice per day: 1 drop in the morning and 1 drop at night before bedtime) and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses Receives: Device: Defocus Incorporated Multiple Segments lenses; Drug: Low dose atropine |
| Low dose atropine | Experimental | This group will receive 0.01% atropine (twice per day: 1 drop in the morning and 1 drop at night before bedtime) and single vision spectacle lenses Receives: Device: single vision spectacle lenses; Drug: Low dose atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cycloplegic refraction
Changes in cycloplegic refraction in spherical equivalent (Dioptres) over 18 months from baseline will be measured.
Measured: Baseline, 6th month, 12th month and 18th month
Changes in axial length
Changes in axial length (mm) over 18 months from baseline will be measured.
Measured: Baseline, 6th month, 12th month and 18th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start12 Jul 2024
- Primary completion25 Apr 2026
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Model description
- Eligible participants will be randomly allocated into 2 groups. One group will receive low dose atropine (0.01%) plus DIMS spectacles (ATD Group); another one will receive low dose atropine (0.01%) plus single vision spectacles (AT Group).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 112 participants (estimated)
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
- Rachel Ka Man Chun, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358755
- Sponsor's protocol ID
- 10211476
- Other IDs
- P0041308
- Status last verified
- Apr 2026
- First submitted
- 20 Mar 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chun RKM, Hon Y, Law TK, Wong KYQ, To CH, Shih KC, Leung CKS, Tse DYY. Combination effect of optical defocus and low dose atropine in myopia control: Study protocol for a randomized clinical trial. PLoS One. 2024 Jun 26;19(6):e0306050. doi: 10.1371/journal.pone.0306050. eCollection 2024.
PubMed 38923965
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Effect of Optical Defocus and Low Dose Atropine in Myopia Control - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06358755
- Acronym / sponsor ID
- 10211476
- Conditions
- Myopia
- Keywords
- Myopia control, Defocus, Atropine
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- The University of Hong Kong
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 25 Apr 2026 (actual)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 11 Apr 2024 (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 combination effect of optical defocus and low dose atropine on myopia control in schoolchildren.
Detailed description
This study is a two-arm randomised controlled trial with a 18-month duration. Participants will be healthy Hong Kong Chinese schoolchildren with low to moderate myopia. The aim is to determine the combination effect of optical defocus and low dose atropine on myopia control in schoolchildren. Optical defocus will be delivered by Defocus Incorporated Multiple Segments (DIMS) spectacle lenses.
A total of 112 Hong Kong Chinese children aged 7 to 12 years (56 in each group) will be recruited and randomly allocated into two groups. One group will receive low dose atropine (0.01%) plus DIMS spectacles (ATD Group); another one will receive low dose atropine (0.01%) plus single vision spectacles (AT Group).
They must have no 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.
Their cycloplegic refraction and axial length will be monitored every six months for 18 months. 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 (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible participants will be randomly allocated into 2 groups. One group will receive low dose atropine (0.01%) plus DIMS spectacles (ATD Group); another one will receive low dose atropine (0.01%) plus single vision spectacles (AT Group).
| Arm | Type | Receives |
|---|---|---|
| Low dose atropine plus DIMS | Experimental | Device: Defocus Incorporated Multiple Segments lenses, Drug: Low dose atropineThis group will receive 0.01% atropine (twice per day: 1 drop in the morning and 1 drop at night before bedtime) and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses |
| Low dose atropine | Experimental | Device: single vision spectacle lenses, Drug: Low dose atropineThis group will receive 0.01% atropine (twice per day: 1 drop in the morning and 1 drop at night before bedtime) and single vision spectacle lenses |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Age at enrollment: 7 to 12 years
- Ethnicity: Hong Kong Chinese
- Myopia: -0.75D (in spherical equivalent) or above in both eyes
- Astigmatism: -1.50D or less in both eyes
- Anisometropia: 1.50D or less (in spherical equivalent) between two eyes
Key exclusion criteria (8 listed)
- Eye disease or binocular vision problems (e.g., strabismus, amblyopia, oculomotor nerve palsies, corneal disease, etc.)
- Previous intraocular or corneal surgery
- Colour vision deficiencies
- Systemic disease that may affect vision, vision development (e.g. diabetes mellitus, hypertension, Down syndrome, etc.)
- Systemic disease that are contradictory to atropine (e.g. asthma, cardiac diseases, etc.)
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 |
|---|---|---|
| Defocus Incorporated Multiple Segments lensesDefocus Incorporated Multiple Segments lenses that provide optical defocus for myopia control will be given to this group of participants. | Device | Low dose atropine plus DIMS |
| single vision spectacle lensesSingle vision spectacle lenses will be given to this group of participants. | Device | Low dose atropine |
| Low dose atropine0.01% atropine administrated twice per day (1 drop in the morning and 1 drop at night before bedtime) will be given as intervention. | Drug | Low dose atropine, Low dose atropine plus DIMS |
Primary outcome
Changes in cycloplegic refraction
Time frame: Baseline, 6th month, 12th month and 18th month
Changes in cycloplegic refraction in spherical equivalent (Dioptres) over 18 months from baseline will be measured.
Changes in axial length
Time frame: Baseline, 6th month, 12th month and 18th month
Changes in axial length (mm) over 18 months from baseline will be measured.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Derived from this study: PubMed 38923965Chun RKM, Hon Y, Law TK, Wong KYQ, To CH, Shih KC, Leung CKS, Tse DYY. Combination effect of optical defocus and low dose atropine in myopia control: Study protocol for a randomized clinical trial. PLoS One. 2024 Jun 26;19(6):e0306050. doi: 10.1371/journal.pone.0306050. eCollection 2024.
- 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.
Rachel Ka Man Chun, PhD principal investigator
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 Defocus Incorporated Multiple Segments lenses, single vision spectacle lenses and Low dose atropine 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 13 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 17 Sep 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?
This study is still under way. Results are not available in the source record yet.
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?
Changes in cycloplegic refraction (time frame: Baseline, 6th month, 12th month and 18th month). The study lists 2 primary outcomes in all. 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 NCT06358755, which also lists 1 linked publication.
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 17 Sep 2026.