An interventional study of Routine Screening and Referral and AI-Guided Tiered Management in Myopia, sponsored by Shanghai Eye Disease Prevention and Treatment Center. Not yet recruiting at 3 sites in China. Open to participants aged 6 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Shanghai Eye Disease Prevention and Treatment Center · Not applicable, Interventional, and Prevention
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.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's planned enrollment of 1,600 is above the median of 78 across 923 interventional studies indexed under Myopia.
Browse Myopia studies →Shanghai Eye Disease Prevention and Treatment Center is the lead sponsor of 66 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
School level:
Inclusion Criteria:
Exclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: AI-Guided Tiered Management
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.
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.
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.
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
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
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
Start is estimated for Sep 2026; primary completion for Oct 2027, 13 months later.
Of 200 non-industry interventional studies with no phase under Myopia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 13 months is below that.
Counting every sponsor, half of 434 studies reached it within 14 months; a quarter within 3 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Shanghai Eye Disease Prevention and Treatment Center