Pre-myopiaNCT07914114
The Efficacy of a Polarized Folded Optical Path-based Reading-writing Desk for Myopia Prevention and Control in Pre-myopic Children
A study testing Polarized folded optical path reading and writing device and Eye-care desk lamp and desk posture corrector in people with Pre-myopia, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of the polarized folded optical path reading and writing device in myopia prevention onset in 5-10 year old children with pre myopia. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-myopia
- What is being tested?
- Polarized folded optical path reading and writing device and Eye-care desk lamp and desk posture corrector
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 13 Oct 2026to 30 Jun 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 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 5 to 10 years (inclusive) on the date of signing informed consent.
- Pre myopia status, defined as a spherical equivalent refraction (SER) measured by cycloplegic refraction in both eyes, with values satisfying -0.50 D < SER ≤ +0.75 D.
- Astigmatism (cylinder power) ≤1.50 D and anisometropia ≤1.50 D in both eyes.
- A daily need for reading and writing, and a home environment that allows the use of the reading and writing device / eye protection desk lamp and posture corrector.
- Signed informed consent obtained from the parent(s) or legal guardian(s); for children aged 7 years and older, an additional child assent form must also be signed.
- Willingness to comply with the scheduled follow up visits throughout the 24 month study period, with no plan for long term relocation to a different area.
Who cannot join
- Any ocular disease that may affect refractive development, including amblyopia, strabismus, congenital cataract, glaucoma, keratoconus, ptosis, significant ocular surface disease, or other relevant conditions.
- Use of any of the following myopia control interventions within 6 months prior to enrollment: orthokeratology (OK) lenses, low concentration atropine, repeated low level red light therapy, defocus incorporated soft contact lenses, peripheral defocus spectacle lenses, pirenzepine, or any other medication/device known to have a myopia control effect.
- Presence of systemic diseases (e.g., neurodevelopmental disorders, connective tissue diseases, or ongoing systemic glucocorticoid therapy or other medications affecting ocular development) that may influence visual development or study compliance.
- Known allergy to cycloplegic agents in the child or parent/guardian.
- Explicit statement by the parent/guardian of intention to use additional myopia interventions during the study period.
- Any other condition deemed by the principal investigator (PI) to render the participant unsuitable for enrollment.
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
Beijing Tongren Hospital
Beijing
Mengtian Kang, Doctoral degree, +86 13581788600, kangmengtian@163.com
About this study
Official title: A Randomized Controlled Trial on the Efficacy of a Polarized Folded Optical Path-based Reading-writing Desk for Myopia Prevention and Control in Pre-myopic Children
The goal of this clinical trial is to evaluate the efficacy and safety of the polarized folded optical path reading and writing device in myopia prevention onset in 5-10 year old children with pre myopia. It will also integrate AI based fundus photography risk stratification, wearable environmental exposure monitoring, and far display screen behavioral recognition data to construct predictive models for myopia onset risk and intervention response, thereby establishing a precision prevention and control paradigm for this population. The main questions it aims to answer are:
- How can early risk identification, scenario based precision intervention, and objective efficacy prediction be achieved in pre myopic children?
- What is the mechanism of action of the device on the accommodation-choroid-axial length axis?
- What is the dose-response relationship among multispectral input, real world visual behaviors, and prophylactic efficacy?
- How does the multimodal collaborative regulatory mechanism integrating risk stratification, environmental monitoring, and behavioral recognition operate？ Researchers will compare participants using the polarized folded optical path reading and writing device against those not equipped with equivalent viewing distance extending optical devices (Intervention Group: using the polarized folded optical path reading and writing device; control group: not equipped with equivalent viewing distance extending optical devices) to determine the relative efficacy of the device in controlling myopia progression.
Read more
Participants will:
- If assigned to the intervention group, use the polarized folded optical path reading and writing device as their daily reading and writing tool for 12 months, with a target usage of ≥2 hours/day and ≥5 compliant days/week; if assigned to the control group, use myopia prevention desk lamps and posture correctors while maintaining their habitual visual behaviors.
- Attend clinic visits at baseline and at 3, 6, 9, and 12 months for comprehensive eye examinations.
- Maintain diaries documenting wearable environmental exposure data, real world far display screen usage behaviors, and any adverse events; additionally, undergo collection of color fundus photographs and AI derived fundus risk scores at the scheduled visits.
- Conditions
- Pre-myopia
- Being tested
- Polarized folded optical path reading and writing device, Eye-care desk lamp and desk posture corrector
- Keywords
- Myopia prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polarized folded optical path reading and writing deviceDevice
Polarized folded optical path reading and writing device. Through polarized folded optical path, it transforms near-work visual input into a distant virtual image.
Eye-care desk lamp and desk posture correctorDevice
Participants in the control group will use an eye-care desk lamp and a desk posture corrector (with a reading and writing distance of 33 cm).
| Study group | Role | What they receive |
|---|---|---|
| polarized folded optical path reading and writing device | Experimental | Not described Receives: Device: Polarized folded optical path reading and writing device |
| Control group | Active comparator | Not described Receives: Device: Eye-care desk lamp and desk posture corrector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of myopia
The proportion of participants who develop myopia during the follow-up period among those who were non-myopic at baseline.
Measured: from baseline to 24±1 months
Secondary outcomes (6)
Change in Axial Length (AL)
Measured: baseline and 3, 6, 9, 12, 15, 18, 21, 24 months.
Change in accommodative lag
Measured: from baseline to 24±1 months
Change in Spherical Equivalent Refraction (SER)
Measured: baseline and 3, 6, 9, 12, 15, 18, 21, 24 months.
Change in NITM amplitude
Measured: from baseline to 24±1 months
Choroidal thickness
Measured: from baseline to 24±1 months
Incidence of myopic fundus changes
The proportion of participants who develop any of the following myopic fundus changes on color fundus photography during the follow-up period, among those without these changes at baseline:
- tessellated fundus (visible choroidal vessels in the posterior pole),
- optic disc tilt (tilt ratio ≤ 0.75),
- peripapillary atrophy,
- posterior staphyloma,
- myopic maculopathy (META-PM Category ≥ 2). Participants with any one of these findings at any follow-up visit are counted as incident cases.
Measured: from baseline to 24±1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start13 Oct 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-myopiaStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- BOE Technology Group Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914114
- Sponsor's protocol ID
- L2609037
- Other IDs
- L2609037
- Status last verified
- Oct 2026
- First submitted
- 14 Sep 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Efficacy of a Polarized Folded Optical Path-based Reading-writing Desk for Myopia Prevention and Control in Pre-myopic Children
- ClinicalTrials.gov ID
- NCT07914114
- Acronym / sponsor ID
- L2609037
- Conditions
- Pre-myopia
- Keywords
- Myopia prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Collaborators
- BOE Technology Group Co., Ltd.
- Study start
- 13 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 3 Nov 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 clinical trial is to evaluate the efficacy and safety of the polarized folded optical path reading and writing device in myopia prevention onset in 5-10 year old children with pre myopia. It will also integrate AI based fundus photography risk stratification, wearable environmental exposure monitoring, and far display screen behavioral recognition data to construct predictive models for myopia onset risk and intervention response, thereby establishing a precision prevention and control paradigm for this population. The main questions it aims to answer are:
- How can early risk identification, scenario based precision intervention, and objective efficacy prediction be achieved in pre myopic children?
- What is the mechanism of action of the device on the accommodation-choroid-axial length axis?
- What is the dose-response relationship among multispectral input, real world visual behaviors, and prophylactic efficacy?
- How does the multimodal collaborative regulatory mechanism integrating risk stratification, environmental monitoring, and behavioral recognition operate？ Researchers will compare participants using the polarized folded optical path reading and writing device against those not equipped with equivalent viewing distance extending optical devices (Intervention Group: using the polarized folded optical path reading and writing device; control group: not equipped with equivalent viewing distance extending optical devices) to determine the relative efficacy of the device in controlling myopia progression.
Participants will:
- If assigned to the intervention group, use the polarized folded optical path reading and writing device as their daily reading and writing tool for 12 months, with a target usage of ≥2 hours/day and ≥5 compliant days/week; if assigned to the control group, use myopia prevention desk lamps and posture correctors while maintaining their habitual visual behaviors.
- Attend clinic visits at baseline and at 3, 6, 9, and 12 months for comprehensive eye examinations.
- Maintain diaries documenting wearable environmental exposure data, real world far display screen usage behaviors, and any adverse events; additionally, undergo collection of color fundus photographs and AI derived fundus risk scores at the scheduled visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| polarized folded optical path reading and writing device | Experimental | Device: Polarized folded optical path reading and writing device |
| Control group | Active comparator | Device: Eye-care desk lamp and desk posture corrector |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 5 to 10 years (inclusive) on the date of signing informed consent.
- Pre myopia status, defined as a spherical equivalent refraction (SER) measured by cycloplegic refraction in both eyes, with values satisfying -0.50 D < SER ≤ +0.75 D.
- Astigmatism (cylinder power) ≤1.50 D and anisometropia ≤1.50 D in both eyes.
- A daily need for reading and writing, and a home environment that allows the use of the reading and writing device / eye protection desk lamp and posture corrector.
- Signed informed consent obtained from the parent(s) or legal guardian(s); for children aged 7 years and older, an additional child assent form must also be signed.
Key exclusion criteria (6 listed)
- Any ocular disease that may affect refractive development, including amblyopia, strabismus, congenital cataract, glaucoma, keratoconus, ptosis, significant ocular surface disease, or other relevant conditions.
- Use of any of the following myopia control interventions within 6 months prior to enrollment: orthokeratology (OK) lenses, low concentration atropine, repeated low level red light therapy, defocus incorporated soft contact lenses, peripheral defocus spectacle lenses, pirenzepine, or any other medication/device known to have a myopia control effect.
- Presence of systemic diseases (e.g., neurodevelopmental disorders, connective tissue diseases, or ongoing systemic glucocorticoid therapy or other medications affecting ocular development) that may influence visual development or study compliance.
- Known allergy to cycloplegic agents in the child or parent/guardian.
- Explicit statement by the parent/guardian of intention to use additional myopia interventions during the study 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 |
|---|---|---|
| Polarized folded optical path reading and writing devicePolarized folded optical path reading and writing device. Through polarized folded optical path, it transforms near-work visual input into a distant virtual image. | Device | polarized folded optical path reading and writing device |
| Eye-care desk lamp and desk posture correctorParticipants in the control group will use an eye-care desk lamp and a desk posture corrector (with a reading and writing distance of 33 cm). | Device | Control group |
Primary outcome
Incidence of myopia
Time frame: from baseline to 24±1 months
The proportion of participants who develop myopia during the follow-up period among those who were non-myopic at baseline.
6 secondary outcomes
Change in Axial Length (AL)
Time frame: baseline and 3, 6, 9, 12, 15, 18, 21, 24 months.
Change in accommodative lag
Time frame: from baseline to 24±1 months
Change in Spherical Equivalent Refraction (SER)
Time frame: baseline and 3, 6, 9, 12, 15, 18, 21, 24 months.
Change in NITM amplitude
Time frame: from baseline to 24±1 months
Choroidal thickness
Time frame: from baseline to 24±1 months
Incidence of myopic fundus changes
Time frame: from baseline to 24±1 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 3 Nov 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polarized folded optical path reading and writing device and Eye-care desk lamp and desk posture corrector in people with Pre-myopia, 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 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: opening soon, as of the sponsor's last update on 3 Nov 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?
Incidence of myopia (time frame: from baseline to 24±1 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 3 Nov 2026.