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Not yet recruitingNCT07914114Updated Nov 3, 2026

The Efficacy of a Polarized Folded Optical Path-based Reading-writing Desk for Myopia Prevention and Control in Pre-myopic Children

An interventional study of Polarized folded optical path reading and writing device and Eye-care desk lamp and desk posture corrector in Pre-myopia, sponsored by Beijing Tongren Hospital. Not yet recruiting at 1 site in China. Open to participants aged 5 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Beijing Tongren Hospital · Not applicable, Interventional, and Prevention

Updated Nov 3, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
5 Years to 10 Years
Sex
All
01

Study 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. 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.
02

Conditions studied

  • Pre-myopia

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Keywords

  • Myopia prevention
03

In context

Myopia

1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.

This study's planned enrollment of 200 is above the median of 78 across 923 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Beijing Tongren Hospital is the lead sponsor of 164 studies on the registry; 54 are open to participants now.

Browse Beijing Tongren Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 5 to 10 years (inclusive) on the date of signing .
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

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05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    polarized folded optical path reading and writing device

    Device: Polarized folded optical path reading and writing device

  • Active comparator
    Control group

    Device: Eye-care desk lamp and desk posture corrector

Interventions

  • DevicePolarized folded optical path reading and writing device

    Polarized folded optical path reading and writing device. Through polarized folded optical path, it transforms near-work visual input into a distant virtual image.

  • DeviceEye-care desk lamp and desk posture corrector

    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).

06

What researchers measure

Primary outcomes

  1. Incidence of myopia

    The proportion of participants who develop myopia during the follow-up period among those who were non-myopic at baseline.

    Time frame: from baseline to 24±1 months

Secondary outcomes

  1. Change in Axial Length (AL)

    Time frame: baseline and 3, 6, 9, 12, 15, 18, 21, 24 months.

  2. Change in accommodative lag

    Time frame: from baseline to 24±1 months

  3. Change in Spherical Equivalent Refraction (SER)

    Time frame: baseline and 3, 6, 9, 12, 15, 18, 21, 24 months.

  4. Change in NITM amplitude

    Time frame: from baseline to 24±1 months

  5. Choroidal thickness

    Time frame: from baseline to 24±1 months

  6. 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: 1. tessellated fundus (visible choroidal vessels in the posterior pole), 2. optic disc tilt (tilt ratio ≤ 0.75), 3. peripapillary atrophy, 4. posterior staphyloma, 5. myopic maculopathy (META-PM Category ≥ 2). Participants with any one of these findings at any follow-up visit are counted as incident cases.

    Time frame: from baseline to 24±1 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07914114
Lead sponsor
Beijing Tongren Hospital
Collaborators
BOE Technology Group Co., Ltd.
Responsible party
Sponsor
First posted
Nov 3, 2026
Start date
Oct 13, 2026 (estimated)
Primary completion
Jun 30, 2028 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Nov 3, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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