MyopiaNCT07547072
Choroidal Response to the Modified Defocus Incorporated Multiple Segments Spectacle Lenses
A study testing Modified Defocus Incorporated Multiple Segments lens (D1) and Modified Defocus Incorporated Multiple Segments lens (D2) in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The goal of this study is to investigate the short-term changes in choroidal thickness and efficacy of the study spectacle lenses in children. Participants will be prescribed with a pair of study spectacle lenses for daily use and visit the clinic once every week for the first month for checkup and tests. Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Modified Defocus Incorporated Multiple Segments lens (D1) and Modified Defocus Incorporated Multiple Segments lens (D2)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteHong Kong
- Study dates
- 24 Apr 2026to 29 Feb 2028
- 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 6 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Hong Kong Chinese
- Age at enrolment: 6 - 13 years
- Myopia in spherical power: -1.00D to -5.00D in both eyes
- Astigmatism: equal or less than 2.00D
- The sum of spherical power and astigmatism: equal or less than -7.00D
- Anisometropia (spherical equivalent refraction (SER)): equal or less than 1.50D
Show all 14Show fewer
- Previous myopia progression (valid documentation dated within 2 years before screening):
- -0.50D (SER) per year or more in both eyes OR Axial length elongation: 0.27mm/year in both eyes
- If myopia is initially detected during screening, eligibility requires myopia (in SER) below the 3rd percentile curve of refraction in both eyes.12
- Best corrected visual acuity: LogMAR 0.04 or better in both eyes
- Ocular health: no abnormalities in both internal and external ocular health
- Binocular vision: no strabismus and other binocular abnormalities
- Normal colour vision
- Willing to wear the study spectacles all the time (10 hours per day, for 7 days per week)
Who cannot join
- Previous or current treatment for myopia control (e.g., red-light therapy, atropine, orthokeratology, specialized spectacle lenses and contact lenses and oral supplements for myopic control)
- Existing or past eye diseases or surgeries (e.g., strabismus surgery, amblyopia, oculomotor nerve palsies, corneal disease, intraocular disease, etc.) that may have an impact on vision or visual development
- Long-term medication (intake at least 3 days/week) or medication/supplements that affect eye health
- Systemic diseases that may have an impact on vision or visual development (e.g., endocrine, cardiac and respiratory diseases, diabetes, Down syndrome, etc.)
- Allergic to cyclopentolate eye drops
- Individuals who, in the judgment of the Investigator, are unable to cooperate and follow instructions during eye examination.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Optometry Research Clinic, School of Optometry, The Hong Kong Polytechnic University
Kowloon, Hong Kong
Rachel Ka-man Chun, PhD, 852-27664224, rachel.chun@polyu.edu.hk
Dennis Yan-yin Tse, PhD, 852-27666096, dennis.tse@polyu.edu.hk
About this study
Official title: Choroidal Responses to the Modified Defocus Incorporated Multiple Segments (DIMS) Spectacle Lenses
The goal of this study is to investigate the short-term changes in choroidal thickness and efficacy of the study spectacle lenses in children. Participants will be prescribed with a pair of study spectacle lenses for daily use and visit the clinic once every week for the first month for checkup and tests. After the first month of follow-up, participants will visit at 1 month, 6- and 12-month for checkup. Choroidal thickness, axial length and refractive errors will be monitored.
Read the detailed description
Optical interventions have been widely used for myopia control in children, however, the effectiveness varied between individuals. The current study spectacle lenses are modified based on DIMS technology.
Participants will be randomly allocated to single vision (SV) lens group (control), D1 or D2 group (treatment). The weekly choroidal thickness changes will be monitored in the first month of lens wear. Their cycloplegic refraction and axial length will be monitored every 6 months for 1 year.
- Conditions
- Myopia
- Being tested
- Modified Defocus Incorporated Multiple Segments lens (D1), Modified Defocus Incorporated Multiple Segments lens (D2)
- Keywords
- Myopia, Choroidal thickness
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Defocus Incorporated Multiple Segments lens (D1)Other
D1 is a modified Defocus Incorporated Multiple Segments lens that corrects the distance refraction and provides myopic defocus simultaneously
Modified Defocus Incorporated Multiple Segments lens (D2)Other
D2 is a modified Defocus Incorporated Multiple Segments lens that corrects the distance refraction and provides myopic defocus simultaneously
| Study group | Role | What they receive |
|---|---|---|
| Single vision lens group | No intervention | Participants in single vision lens group will receive a pair of single vision lenses for 1 year after the short-term monitoring of choroidal thickness. |
| D1 lens group | Experimental | Participants in D1 lens group will receive a pair of D1 lenses over 1 year after the short-term monitoring of choroidal thickness. Receives: Other: Modified Defocus Incorporated Multiple Segments lens (D1) |
| D2 lens group | Experimental | Participants in D2 lens group will receive a pair of D2 lenses over 1 year after the short-term monitoring of choroidal thickness. Receives: Other: Modified Defocus Incorporated Multiple Segments lens (D2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choroidal thickness changes
Choroidal thickness will be measured by a swept source optical coherence tomographer. Changes in choroidal thickness from baseline over the first month and every 6 months for 1 year over the study period.
Measured: Baseline, every week for 1 month, every 6 months over 1 year
Secondary outcomes (2)
Cycloplegic refraction change in spherical equivalent refraction (SER)
Cycloplegic SER (in diopter) will be measured using an open field autorefractor. Change in SER with cycloplegia from the baseline every 6 months for 1 year over the study period.
Measured: Baseline, 6 and 12 months
Axial length changes
Axial length (mm) will be measured after cycloplegia using a non-contact optical biometer. Change in axial length from the baseline every 6 months for 1 year over the study period.
Measured: Baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start24 Apr 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- HOYA Lens Thailand LTD.
- Responsible party
- Sponsor
- Investigators
- Rachel Ka Man Chun, PhD, Principal investigator, School of Optometry, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547072
- Sponsor's protocol ID
- H-ZGU1
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Choroidal Responses to the Modified Defocus Incorporated Multiple Segments (DIMS) Spectacle Lenses
- ClinicalTrials.gov ID
- NCT07547072
- Acronym / sponsor ID
- H-ZGU1
- Conditions
- Myopia
- Keywords
- Myopia, Choroidal thickness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- HOYA Lens Thailand LTD.
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 23 Apr 2026 (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 goal of this study is to investigate the short-term changes in choroidal thickness and efficacy of the study spectacle lenses in children. Participants will be prescribed with a pair of study spectacle lenses for daily use and visit the clinic once every week for the first month for checkup and tests. After the first month of follow-up, participants will visit at 1 month, 6- and 12-month for checkup. Choroidal thickness, axial length and refractive errors will be monitored.
Detailed description
Optical interventions have been widely used for myopia control in children, however, the effectiveness varied between individuals. The current study spectacle lenses are modified based on DIMS technology.
Participants will be randomly allocated to single vision (SV) lens group (control), D1 or D2 group (treatment). The weekly choroidal thickness changes will be monitored in the first month of lens wear. Their cycloplegic refraction and axial length will be monitored every 6 months for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single vision lens group | No intervention | –Participants in single vision lens group will receive a pair of single vision lenses for 1 year after the short-term monitoring of choroidal thickness. |
| D1 lens group | Experimental | Other: Modified Defocus Incorporated Multiple Segments lens (D1)Participants in D1 lens group will receive a pair of D1 lenses over 1 year after the short-term monitoring of choroidal thickness. |
| D2 lens group | Experimental | Other: Modified Defocus Incorporated Multiple Segments lens (D2)Participants in D2 lens group will receive a pair of D2 lenses over 1 year after the short-term monitoring of choroidal thickness. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Hong Kong Chinese
- Age at enrolment: 6 - 13 years
- Myopia in spherical power: -1.00D to -5.00D in both eyes
- Astigmatism: equal or less than 2.00D
- The sum of spherical power and astigmatism: equal or less than -7.00D
Key exclusion criteria (6 listed)
- Previous or current treatment for myopia control (e.g., red-light therapy, atropine, orthokeratology, specialized spectacle lenses and contact lenses and oral supplements for myopic control)
- Existing or past eye diseases or surgeries (e.g., strabismus surgery, amblyopia, oculomotor nerve palsies, corneal disease, intraocular disease, etc.) that may have an impact on vision or visual development
- Long-term medication (intake at least 3 days/week) or medication/supplements that affect eye health
- Systemic diseases that may have an impact on vision or visual development (e.g., endocrine, cardiac and respiratory diseases, diabetes, Down syndrome, etc.)
- Allergic to cyclopentolate eye drops
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 |
|---|---|---|
| Modified Defocus Incorporated Multiple Segments lens (D1)D1 is a modified Defocus Incorporated Multiple Segments lens that corrects the distance refraction and provides myopic defocus simultaneously | Other | D1 lens group |
| Modified Defocus Incorporated Multiple Segments lens (D2)D2 is a modified Defocus Incorporated Multiple Segments lens that corrects the distance refraction and provides myopic defocus simultaneously | Other | D2 lens group |
Primary outcome
Choroidal thickness changes
Time frame: Baseline, every week for 1 month, every 6 months over 1 year
Choroidal thickness will be measured by a swept source optical coherence tomographer. Changes in choroidal thickness from baseline over the first month and every 6 months for 1 year over the study period.
2 secondary outcomes
Cycloplegic refraction change in spherical equivalent refraction (SER)
Time frame: Baseline, 6 and 12 months
Axial length changes
Time frame: Baseline, 6 and 12 months
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.
- 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.
Rachel Ka Man Chun, 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 Modified Defocus Incorporated Multiple Segments lens (D1) and Modified Defocus Incorporated Multiple Segments lens (D2) 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 14 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: looking for participants now, 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?
Contact Rachel Ka Man Chun, PhD (852-27664224, rachel.chun@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Choroidal thickness changes (time frame: Baseline, every week for 1 month, every 6 months over 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.