Health Condition 1: H521- Myopia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: School-going children aged 6 to 18 years Enrolled in selected schools across urban and rural areas of Bhopal Division (Madhya Pradesh) Parental or legal guardian consent and age-appropriate child assent provided Willing to participate in ocular assessments and periodic follow-ups over 24 months
Exclusion criteria
Exclusion criteria: History of ocular trauma, congenital anomalies, or prior eye surgeries Children with systemic illnesses affecting vision (e.g., diabetes, neurological disorders) Inability to cooperate with eye exams or data collection Already enrolled in another interventional ophthalmic study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Spherical Equivalent Refraction (SER) to quantify progression of myopia. Change in Axial Length to assess ocular growth associated with myopia progression. Time Points for Assessment: Baseline (at enrolment) 6 months from baseline 12 months from baselinTimepoint: Outcome: Change in Spherical Equivalent Refraction (SER) and Axial Length used to measure and quantify myopia progression in school-going children. Time Points: At baseline (enrolment), at 6 months, and at 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| AI Model Performance Metrics Accuracy, Sensitivity, Specificity, AUROC, F1 Score Timepoint: After each longitudinal data collection point 6, 12, 18, and 24 months;Identification and Ranking of Dominant Risk Factors (e.g., screen time, parental myopia, near work duration) Timepoint: At end of Phase 1 (Baseline cross-sectional analysis);Validation Accuracy of Mobile Application Predictions vs. clinical diagnoses (Positive Predictive Value, Kappa score) Timepoint: 18 and 24 months (during pilot testing of the mobile app);Awareness and Behavior Change Metrics Number of children reached, engagement in prevention programs Timepoint: Ongoing throughout study; evaluated cumulatively at 12, 18, and 24 months | — |
Countries
India
Contacts
All India Institute of Medical Sciences, Bhopal