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NCT07825428

AI-Stratified Myopia Control for Children in Remote Areas

Sponsor: Shanghai Eye Disease Prevention and Treatment Center

View on ClinicalTrials.gov

Summary

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.

Official title: AI-Based Risk-Stratified Intervention Strategy for Myopia Control in Children From Remote Areas: A Cluster Randomized Controlled Trial

Key Details

Gender

All

Age Range

6 Years - 9 Years

Study Type

INTERVENTIONAL

Enrollment

1600

Start Date

2026-09-01

Completion Date

2027-10-31

Last Updated

2026-09-17

Healthy Volunteers

Yes

Conditions

Myopia

Interventions

BEHAVIORAL

Routine Screening and Referral

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.

BEHAVIORAL

AI-Guided Tiered Management

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.

1. 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. 2. 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.

Locations (3)

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Shanghai Eye Disease Prevention & Treatment Center

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China