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NCT07914114
The Efficacy of a Polarized Folded Optical Path-based Reading-writing Desk for Myopia Prevention and Control in Pre-myopic Children
Conditions: Pre-myopia
Sex: All
Ages: 5 Years – 10 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 200
Sponsor: Beijing Tongren Hospital
Location: Beijing Tongren Hospital Beijing
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07914114). StuddyBuddy aggregates publicly available trial information.