The Efficacy of a Polarized Folded Optical Path-based Reading-writing Desk for Myopia Prevention and Control in Pre-myopic Children
29 octobre 2026 mis à jour par: Beijing Tongren Hospital
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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Type d'étude
Interventionnel
Inscription (Estimé)
200
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Beijing, Chine
- Beijing Tongren Hospital
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Contact:
- Mengtian Kang, Doctoral degree
- Numéro de téléphone: +86 13581788600
- E-mail: kangmengtian@163.com
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
5 ans à 10 ans (Enfant)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Groupe de contrôle
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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). |
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Expérimental: polarized folded optical path reading and writing device
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Polarized folded optical path reading and writing device. Through polarized folded optical path, it transforms near-work visual input into a distant virtual image. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Incidence of myopia
Délai: from baseline to 24±1 months
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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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Axial Length (AL)
Délai: baseline and 3, 6, 9, 12, 15, 18, 21, 24 months.
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baseline and 3, 6, 9, 12, 15, 18, 21, 24 months.
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|
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Change in accommodative lag
Délai: from baseline to 24±1 months
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from baseline to 24±1 months
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Change in Spherical Equivalent Refraction (SER)
Délai: baseline and 3, 6, 9, 12, 15, 18, 21, 24 months.
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baseline and 3, 6, 9, 12, 15, 18, 21, 24 months.
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Change in NITM amplitude
Délai: from baseline to 24±1 months
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from baseline to 24±1 months
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Choroidal thickness
Délai: from baseline to 24±1 months
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from baseline to 24±1 months
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Incidence of myopic fundus changes
Délai: from baseline to 24±1 months
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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:
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from baseline to 24±1 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
13 octobre 2026
Achèvement primaire (Estimé)
30 juin 2028
Achèvement de l'étude (Estimé)
30 juin 2028
Dates d'inscription aux études
Première soumission
14 septembre 2026
Première soumission répondant aux critères de contrôle qualité
29 octobre 2026
Première publication (Réel)
3 novembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 novembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 octobre 2026
Dernière vérification
1 octobre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- L2609037
- L2609037 (Autre subvention/numéro de financement: Supported by Beijing Natural Science Foundation(L2609037))
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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