AI-Stratified Myopia Control for Children in Remote Areas

ConditionMyopia

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age6-9

SponsorShanghai Eye Disease Prevention and Treatment Center

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Age of participants is 6-9 years (equivalent to grades 1-3 of primary school).

Trial design

Design model

Parallel

Treatments tested in this trial

Routine Screening and Referral
Behavioral
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.
AI-Guided Tiered Management
Behavioral
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.

Treatment groups

1,600 Participants

are divided into 2 treatment groups

Group A: Intervention GroupExperimental treatment 1 intervention

Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Rapid refractive progression

The rapid refractive progression is defined as axial length elongation \>0.2 mm over 12 months.

Time frame

Baseline to 12 months

Secondary outcomes

Screened myopia

Screened myopia is defined as uncorrected visual acuity \< 5.0 and spherical equivalent refraction \< -0.50 D as measured by non-cycloplegic autorefraction.

Time frame

Baseline to 12 months

Axial length change

Axial length change is defined as the difference in axial length obtained at baseline and at the 12-month follow-up in children.

Time frame

Baseline to 12 months

Other outcomes

Cost-effectiveness

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.

Time frame

During the 12-month follow-up period

Duration of outdoor activity

Outdoor activity duration will be assessed through parent-reported daily diaries at each follow-up visit.

Time frame

During the 12-month follow-up period

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Eye Disease Prevention and Treatment Center

Lead sponsor

Orbis

Collaborator

Shanghai United Foundation

Collaborator

Source ClinicalTrials.gov

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