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

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Pre-myopia
• Intervention / Treatment: Device: Polarized folded optical path reading and writing device; Device: Eye-care desk lamp and desk posture corrector

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Tongren Hospital
    • Contact: Mengtian Kang, Doctoral degree; Phone Number: +86 13581788600; Email: kangmengtian@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Device: Eye-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).
Experimental: polarized folded optical path reading and writing device	Device: Polarized 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of myopia	The proportion of participants who develop myopia during the follow-up period among those who were non-myopic at baseline.	from baseline to 24±1 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Axial Length (AL)		baseline and 3, 6, 9, 12, 15, 18, 21, 24 months.
Change in accommodative lag		from baseline to 24±1 months
Change in Spherical Equivalent Refraction (SER)		baseline and 3, 6, 9, 12, 15, 18, 21, 24 months.
Change in NITM amplitude		from baseline to 24±1 months
Choroidal thickness		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.	from baseline to 24±1 months

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital
• Collaborators: BOE Technology Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): October 13, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: September 14, 2026
• First Submitted That Met QC Criteria: October 29, 2026
• First Posted (Actual): November 3, 2026

Study Record Updates

• Last Update Posted (Actual): November 3, 2026
• Last Update Submitted That Met QC Criteria: October 29, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: Myopia prevention
• Other Study ID Numbers: L2609037; L2609037 (Other Grant/Funding Number: Supported by Beijing Natural Science Foundation(L2609037))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No