AI-Stratified Myopia Control for Children in Remote Areas
AI-Based Risk-Stratified Intervention Strategy for Myopia Control in Children From Remote Areas: A Cluster Randomized Controlled Trial
This cluster-randomized controlled trial aims to evaluate the effectiveness and cost-effectiveness of an artificial intelligence-based, risk-stratified, tiered intervention model for childhood myopia prevention and control in resource-limited county areas of China, compared with the conventional screening-and-referral approach, with schools in project counties of Guizhou or Yunnan Province randomly assigned at a 1:1 ratio to either the intervention or control group over a 12-month follow-up period.
The study is motivated by the pressing reality that myopia among Chinese children is not only widespread but also occurring at younger ages than ever before, bringing with it a lifelong risk of sight-threatening complications, yet in remote county areas, routine vision screening programs are not yet widely available or well-established, due to a shortage of trained eye care professionals, the practical difficulties of performing cycloplegic refraction in school settings, and the lack of systematic follow-up, all of which make it hard to identify children with myopia or pre-myopia. Given that artificial intelligence may offer a practical way to assess risk without the need for pupil dilation, this study will enroll children in grades 1 through 3 from local primary schools. Over 12 months, an AI model will dynamically categorize children based on screening results and guide management adjustments(outdoor activity and defocus lenses) for the intervention group, while the control group receives routine care.
The findings are expected to provide evidence to inform and optimize AI-based myopia prevention and control strategies in remote areas.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Xiangui He, PhD
- Número de teléfono: +86 15000755422
- Correo electrónico: xianhezi@163.com
Ubicaciones de estudio
-
-
Guizhou
-
Guiyang, Guizhou, Porcelana, 550000
- The Affiliated Hospital of Guizhou Medical University
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Porcelana, 200041
- Shanghai Eye Disease Prevention & Treatment Center
-
-
Yunnan
-
Kunming, Yunnan, Porcelana, 650000
- The First Affiliated Hospital of Kunming Medical University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
School level:
Inclusion Criteria:
- The school is a regular public primary school located within a project county in Guizhou Province or Yunnan Province.
- The school has the organizational capacity to conduct myopia screening and follow-up studies in children and adolescents, including the ability to coordinate screening organization, parent communication, informed consent collection, result feedback, and follow-up coordination.
- The number of students in grades 1-3 in study school is sufficient to meet the requirements for conducting a cluster randomized study.
Exclusion Criteria:
- The school has implemented a similar systematic myopia intervention program within the past year that may affect the evaluation of study outcomes.
- Student mobility is high, with a predicted high risk of transfer, missed visits, or loss to follow-up within 12 months.
- There is a lack of accessible medical institutions near the school to support necessary cycloplegic examinations and related services.
- Participant level:
Inclusion Criteria:
- Age of participants is 6-9 years (equivalent to grades 1-3 of primary school).
- Participants can be able to complete baseline and follow-up examinations including visual acuity, non-cycloplegic autorefraction, and axial length measurements.
- For participants who have previously received myopia control interventions such as low-dose atropine eye drops, defocus spectacle lenses, or red-light therapy, a washout period of at least 1 month is required prior to enrollment.
Exclusion Criteria:
- Baseline spherical equivalent refraction (SER) ≤ -10.00 D.
- Presence of ocular or systemic diseases (including infections) that may affect visual acuity or refraction, or use of systemic or topical medications that may alter ocular status or affect ocular health.
- Presence of any ocular conditions that preclude suitability for the interventions in this study, including but not limited to amblyopia, manifest strabismus, or current use of orthokeratology lenses.
- Presence of any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention Group
The intervention group receives routine screening (uncorrected visual acuity + non-cycloplegic autorefraction + axial length), followed by AI-based risk stratification at baseline, 6 months, and 12 months. Tiered interventions are adjusted according to the most recent risk-stratification result into three tiers: hyperopia, pre-myopia, and myopia. Corresponding tiered interventions are provided: outdoor activity (2 h/day on weekends) for tier 1; plano defocus lenses (≥8 h/day) + outdoor activity for tier 2; and defocus lenses (≥12 h/day) + outdoor activity for tier 3. Participants with unclear AI risk stratification or newly onset myopia will be advised to undergo cycloplegic refraction and then to receive study-assigned intervention. For those already using myopia interventions (e.g., atropine, defocus spectacles), guardians will be fully informed of the study plan; if they agree, a 1-month washout period is required before starting the study intervention. |
Students in the intervention group receive routine vision screening followed by AI-based risk stratification, which classifies each student into one of three categories, hyperopia, pre-myopia, or myopia, to guide subsequent tiered interventions.
For children with hyperopia, the intervention consists of prescribed outdoor activities, with a target of 2 hours per day on weekends and daily activity records.
For those with pre-myopia, the intervention combines plano defocus lenses (A.M.L.™) worn for at least 8 hours per day with the same outdoor activity regimen.
For those with myopia, the intervention includes defocus lenses (A.M.L.™) worn for at least 12 hours per day, also combined with outdoor activities and records.
All tiered assignments are dynamically adjusted at each follow-up visit based on the most recent AI classification.
|
|
Comparador activo: Control Group
The control group receives the traditional model of "routine screening + feedback and referral."
Based on routine screening using uncorrected visual acuity combined with non-cycloplegic autorefraction and axial length, screening reports, feedback, and referrals are provided to parents according to the technical standards of the national health industry.
|
Based on routine screening combining uncorrected visual acuity with non-cycloplegic autorefraction and axial length, the control group provides parents with screening reports, feedback, and referrals according to the national health industry standard, which provides tiered recommendations ranging from routine monitoring and eye hygiene, to ophthalmologic consultation for those at risk of myopia, to regular 3- to 6-month re-examination for those with reduced uncorrected but normal corrected visual acuity, and to timely referral for those identified as screening-positive or with possible visual function abnormalities.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Rapid refractive progression
Periodo de tiempo: Baseline to 12 months
|
The rapid refractive progression is defined as axial length elongation >0.2 mm over 12 months.
|
Baseline to 12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Screened myopia
Periodo de tiempo: Baseline to 12 months
|
Screened myopia is defined as uncorrected visual acuity < 5.0 and spherical equivalent refraction < -0.50 D as measured by non-cycloplegic autorefraction.
|
Baseline to 12 months
|
|
Axial length change
Periodo de tiempo: Baseline to 12 months
|
Axial length change is defined as the difference in axial length obtained at baseline and at the 12-month follow-up in children.
|
Baseline to 12 months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cost-effectiveness
Periodo de tiempo: During the 12-month follow-up period
|
Cost-effectiveness in this study refers to the economic evaluation assessing the balance between the resources invested and the health outcomes achieved in the context of childhood myopia prevention and control in resource-limited settings.
|
During the 12-month follow-up period
|
|
Duration of outdoor activity
Periodo de tiempo: During the 12-month follow-up period
|
Outdoor activity duration will be assessed through parent-reported daily diaries at each follow-up visit.
|
During the 12-month follow-up period
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- QX-2026-A-011
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .