The Efficacy of a Polarized Folded Optical Path-based Reading-writing Desk for Myopia Prevention and Control in Pre-myopic Children
29 de octubre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
200
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Beijing, Porcelana
- Beijing Tongren Hospital
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Contacto:
- Mengtian Kang, Doctoral degree
- Número de teléfono: +86 13581788600
- Correo electrónico: kangmengtian@163.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
5 años a 10 años (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Grupo de control
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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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Experimental: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of myopia
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Axial Length (AL)
Periodo de tiempo: 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 accommodative lag
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: from baseline to 24±1 months
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from baseline to 24±1 months
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Choroidal thickness
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
13 de octubre de 2026
Finalización primaria (Estimado)
30 de junio de 2028
Finalización del estudio (Estimado)
30 de junio de 2028
Fechas de registro del estudio
Enviado por primera vez
14 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de octubre de 2026
Publicado por primera vez (Actual)
3 de noviembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de noviembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de octubre de 2026
Última verificación
1 de octubre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- L2609037
- L2609037 (Otro número de subvención/financiamiento: Supported by Beijing Natural Science Foundation(L2609037))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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