Children With MyopiaNCT07323251
Clinical Study on the Effectiveness of Diverse Segments Defocus Optimization in Spectacle Lenses for Slowing Myopia Progression
A study testing Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses in people with Children With Myopia and Treatment, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
Clinical Trial The goal of this clinical trial is to evaluate the effectiveness of two types of Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses in slowing myopia progression in children. It will also assess the safety of these lenses. The main questions it aims to answer are: Do D.S.D.O. Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Children With Myopia, Treatment, Multizone Lens Design for Myopic Defocus
- What is being tested?
- Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2024to 30 Sep 2026
- 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 6-14 years
- Myopic spherical equivalent refraction between -0.75D and -4.00D (inclusive of -0.75D and -4.00D, based on cycloplegic refraction)
- Astigmatism ≤1.50D
- Anisometropia ≤1.50D
- Best-corrected visual acuity (BCVA) reaching 5.0 (0.00 LogMAR) or better in both eyes; monocular BCVA reaching 5.0 (0.00 LogMAR) or better after wearing myopic defocus spectacles
- Absence of organic ocular diseases
- No history of myopia control treatment within the past three months, including orthokeratology, progressive multifocal lenses, peripheral defocus spectacle lenses, bifocal spectacle lenses, defocus-designed soft hydrophilic contact lenses, other myopia control medications, or light-therapy devices
- Voluntary participation in this clinical study and provision of signed informed consent
Who cannot join
- History of ocular trauma or surgery
- Systemic diseases affecting visual function
- Inability to cooperate with examinations
- Poor compliance
- Inability to adhere to wearing requirements and follow-up visits during the trial period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tongren Hospital
Beijing
Mengtian Kang, 86-13581788600, kangmengtian@163.com
About this study
Clinical Trial
The goal of this clinical trial is to evaluate the effectiveness of two types of Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses in slowing myopia progression in children. It will also assess the safety of these lenses. The main questions it aims to answer are:
Read more
Do D.S.D.O. lenses reduce the progression of myopia as measured by changes in cycloplegic refraction and axial length? What adverse events do participants experience when wearing D.S.D.O. lenses? Researchers will compare two optical designs of D.S.D.O. lenses (Intervention Group1: Design 1; Intervention Group2: Design 2) to determine their relative efficacy in controlling myopia progression.
Participants will:
Wear assigned D.S.D.O. lenses daily for 12 months (except during sleep or unavoidable situations).
Attend clinic visits at baseline, 3, 6, 9, and 12 months for comprehensive eye examinations.
Maintain a diary recording daily wear time, visual symptoms, and any adverse events.
- Conditions
- Children With Myopia, Treatment, Multizone Lens Design for Myopic Defocus, Visual Quality, Efficacy
- Being tested
- Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lensesDevice
This clinical trial employs a randomized, parallel-group, superiority design to evaluate two novel optical designs of Diverse Segments Defocus Optimization (D.S.D.O.) myopia management spectacle lenses. A total of 60 myopic Chinese children, aged 6 to 14 years, will be recruited and randomly assigned in a 1:1 ratio to one of two intervention groups. Both groups will receive myopia control spectacles: the Control Group will use D.S.D.O. Lens Design 1, and the Intervention Group will use D.S.D.O. Lens Design 2. Participants are required to wear the assigned spectacles daily for the entire 12-month study duration, except during sleep or other unavoidable circumstances. The spectacles are intended to provide full refractive correction for distance vision while simultaneously incorporating defocus modifications designed to slow myopia progression by manipulating peripheral retinal defocus patterns. The study includes a baseline visit, a dispensing visit, and follow-up assessments at 3, 6, 9
| Study group | Role | What they receive |
|---|---|---|
| Multi-lens zoning myopia defocus Lens 1 (D.S.D.O) | Experimental | Not described Receives: Device: Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses |
| Multi-lens zoning myopia defocus Lens 2(D.S.D.O) | Experimental | Not described Receives: Device: Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Spherical Equivalent Refraction (SER)
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start2 Aug 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mengtian Kang, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323251
- Sponsor's protocol ID
- TREC2024-KY161
- Status last verified
- Dec 2025
- First submitted
- 13 Sep 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Effectiveness of Diverse Segments Defocus Optimization in Spectacle Lenses for Slowing Myopia Progression
- ClinicalTrials.gov ID
- NCT07323251
- Acronym / sponsor ID
- TREC2024-KY161
- Conditions
- Children With Myopia, Treatment, Multizone Lens Design for Myopic Defocus, Visual Quality, Efficacy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 7 Jan 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.
Clinical Trial
The goal of this clinical trial is to evaluate the effectiveness of two types of Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses in slowing myopia progression in children. It will also assess the safety of these lenses. The main questions it aims to answer are:
Do D.S.D.O. lenses reduce the progression of myopia as measured by changes in cycloplegic refraction and axial length? What adverse events do participants experience when wearing D.S.D.O. lenses? Researchers will compare two optical designs of D.S.D.O. lenses (Intervention Group1: Design 1; Intervention Group2: Design 2) to determine their relative efficacy in controlling myopia progression.
Participants will:
Wear assigned D.S.D.O. lenses daily for 12 months (except during sleep or unavoidable situations).
Attend clinic visits at baseline, 3, 6, 9, and 12 months for comprehensive eye examinations.
Maintain a diary recording daily wear time, visual symptoms, and any adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-lens zoning myopia defocus Lens 1 (D.S.D.O) | Experimental | Device: Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses |
| Multi-lens zoning myopia defocus Lens 2(D.S.D.O) | Experimental | Device: Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age 6-14 years
- Myopic spherical equivalent refraction between -0.75D and -4.00D (inclusive of -0.75D and -4.00D, based on cycloplegic refraction)
- Astigmatism ≤1.50D
- Anisometropia ≤1.50D
- Best-corrected visual acuity (BCVA) reaching 5.0 (0.00 LogMAR) or better in both eyes; monocular BCVA reaching 5.0 (0.00 LogMAR) or better after wearing myopic defocus spectacles
Key exclusion criteria (5 listed)
- History of ocular trauma or surgery
- Systemic diseases affecting visual function
- Inability to cooperate with examinations
- Poor compliance
- Inability to adhere to wearing requirements and follow-up visits during the trial period
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 |
|---|---|---|
| Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lensesThis clinical trial employs a randomized, parallel-group, superiority design to evaluate two novel optical designs of Diverse Segments Defocus Optimization (D.S.D.O.) myopia management spectacle lenses. A total of 60 myopic Chinese children, aged 6 to 14 years, will be recruited and randomly assigned in a 1:1 ratio to one of two intervention groups. Both groups will receive myopia control spectacles: the Control Group will use D.S.D.O. Lens Design 1, and the Intervention Group will use D.S.D.O. Lens Design 2. Participants are required to wear the assigned spectacles daily for the entire 12-month study duration, except during sleep or other unavoidable circumstances. The spectacles are intended to provide full refractive correction for distance vision while simultaneously incorporating defocus modifications designed to slow myopia progression by manipulating peripheral retinal defocus patterns. The study includes a baseline visit, a dispensing visit, and follow-up assessments at 3, 6, 9 | Device | Multi-lens zoning myopia defocus Lens 1 (D.S.D.O), Multi-lens zoning myopia defocus Lens 2(D.S.D.O) |
Primary outcome
Change in Spherical Equivalent Refraction (SER)
Time frame: From enrollment to the end of treatment at 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 7 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses in people with Children With Myopia and Treatment, run by Beijing Tongren Hospital at 1 site in China.
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 8 inclusion and 5 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 7 Jan 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 China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Spherical Equivalent Refraction (SER) (time frame: From enrollment to the end of treatment at 12 months). 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 7 Jan 2026.