AI-Based Risk-Stratified Intervention Strategy for Myopia Control in Children From Remote Areas: A Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,600
- 试验地点
- 3
- 主要终点
- Rapid refractive progression
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: AI-Guided Tiered Management (Behavioral)
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.
干预措施: Routine Screening and Referral (Behavioral)
结局指标
主要结局
Rapid refractive progression
时间窗: Baseline to 12 months
The rapid refractive progression is defined as axial length elongation \>0.2 mm over 12 months.
次要结局
- Screened myopia(Baseline to 12 months)
- Axial length change(Baseline to 12 months)