Myopia ProgressingNCT06927414
Light Diffraction Glasses in Preventing and Controlling Myopia in Adolescents
A study testing Functional lens in people with Myopia Progressing, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
This study aims to evaluate the effectiveness of lenses with light diffraction glasses in controlling the progression of myopia in children and adolescents, and to explore the feasibility of effective design, and apply personalized frame lenses for myopia prevention and control. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia Progressing
- What is being tested?
- Functional lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 30 Jun 2025
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: 6-8 years old;
- After using 1% cyclohexanone hydrochloride eye drops (Saifeijie) for ciliary muscle paralysis, binocular spherical power were within 0.00D~-1.75D, binocular cylinder power ≤ 1.50D, the anisometropia is less than 1.50D, the progression of myopia in the past year is greater than 0.5D, the best corrected far vision is at least 4.8, and the near vision is at least 5.0;
- Within 6 months, the myopia prevention and control methods such as multifocal glasses, orthokeratology, defocusing flexible glasses, progressive glasses, atropine eye drops, red light and acupuncture and moxibustion treatment were not used;
- The subject has a willingness to receive treatment and an informed consent form is signed by their legal guardian.
Who cannot join
- Diagnosed constant strabismus;
- Diagnosed pathological myopia;
- Other congenital eye diseases;
- Researchers believe that the patients have other reasons that are not suitable for inclusion in the project.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Eye Diseases Prevention &Treatment Center/ Shanghai Eye Hospital, School of Medicine, Tongji University
Shanghai, Shanghai Municipality, 200050
About this study
Official title: Exploratory Study on the Effectiveness and Safety of Light Diffraction Frame Glasses in Preventing and Controlling Myopia in Children and Adolescents
This study aims to evaluate the effectiveness of lenses with light diffraction glasses in controlling the progression of myopia in children and adolescents, and to explore the feasibility of effective design, and apply personalized frame lenses for myopia prevention and control.
- Conditions
- Myopia Progressing
- Being tested
- Functional lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional lensDevice
Diffractive Optical Element, D.O.E, technology for controlling myopia progression in children and adolescents. and H.A.L.T, highly aspheric lenslet technology) for controlling myopia progression in children and adolescents.
| Study group | Role | What they receive |
|---|---|---|
| Light diffraction lens (Diffractive Optical Element , D.O.E) | Experimental | Not described Receives: Device: Functional lens |
| H. A. L. T, highly aspheric lenslet technology | Active comparator | Not described Receives: Device: Functional lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective refraction equivalent spherical
Measured: 3 months
Secondary outcomes (2)
Axial length
Measured: 3 months
Choroidal thickness
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start1 Feb 2025
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Jun 2025 (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 Myopia ProgressingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927414
- Sponsor's protocol ID
- XSKHR2024-058-006
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhu X, Lin Q, Sun T, Yao W, Chen M, Xu W. Diffractive optical element (D.O.E) spectacle lenses for myopia prevention and control: a small-scale pilot study among younger Chinese children. BMJ Open Ophthalmol. 2026 Jul 16;11(3):e002683. doi: 10.1136/bmjophth-2025-002683.
PubMed 42463267
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on the Effectiveness and Safety of Light Diffraction Frame Glasses in Preventing and Controlling Myopia in Children and Adolescents
- ClinicalTrials.gov ID
- NCT06927414
- Acronym / sponsor ID
- XSKHR2024-058-006
- Conditions
- Myopia Progressing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 15 Apr 2025 (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.
This study aims to evaluate the effectiveness of lenses with light diffraction glasses in controlling the progression of myopia in children and adolescents, and to explore the feasibility of effective design, and apply personalized frame lenses for myopia prevention and control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Light diffraction lens (Diffractive Optical Element , D.O.E) | Experimental | Device: Functional lens |
| H. A. L. T, highly aspheric lenslet technology | Active comparator | Device: Functional lens |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age: 6-8 years old;
- After using 1% cyclohexanone hydrochloride eye drops (Saifeijie) for ciliary muscle paralysis, binocular spherical power were within 0.00D~-1.75D, binocular cylinder power ≤ 1.50D, the anisometropia is less than 1.50D, the progression of myopia in the past year is greater than 0.5D, the best corrected far vision is at least 4.8, and the near vision is at least 5.0;
- Within 6 months, the myopia prevention and control methods such as multifocal glasses, orthokeratology, defocusing flexible glasses, progressive glasses, atropine eye drops, red light and acupuncture and moxibustion treatment were not used;
- The subject has a willingness to receive treatment and an informed consent form is signed by their legal guardian.
Key exclusion criteria (4 listed)
- Diagnosed constant strabismus;
- Diagnosed pathological myopia;
- Other congenital eye diseases;
- Researchers believe that the patients have other reasons that are not suitable for inclusion in the project.
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 |
|---|---|---|
| Functional lensDiffractive Optical Element, D.O.E, technology for controlling myopia progression in children and adolescents. and H.A.L.T, highly aspheric lenslet technology) for controlling myopia progression in children and adolescents. | Device | H. A. L. T, highly aspheric lenslet technology, Light diffraction lens (Diffractive Optical Element , D.O.E) |
Primary outcome
Subjective refraction equivalent spherical
Time frame: 3 months
2 secondary outcomes
Axial length
Time frame: 3 months
Choroidal thickness
Time frame: 3 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 15 Apr 2025.
- Derived from this study: PubMed 42463267Zhu X, Lin Q, Sun T, Yao W, Chen M, Xu W. Diffractive optical element (D.O.E) spectacle lenses for myopia prevention and control: a small-scale pilot study among younger Chinese children. BMJ Open Ophthalmol. 2026 Jul 16;11(3):e002683. doi: 10.1136/bmjophth-2025-002683.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional lens in people with Myopia Progressing, run by Shanghai Eye Disease Prevention and Treatment Center 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 4 inclusion and 4 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 15 Apr 2025. 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?
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?
Subjective refraction equivalent spherical (time frame: 3 months). 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 NCT06927414, 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 15 Apr 2025.