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CTRI Number  CTRI/2025/07/091243 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 21/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Study on the Use of Artificial Intelligence to Track and Predict Eye Power Changes in School-Going Children 
Scientific Title of Study   Development of an Artificially Intelligent Tool for Analysis and Prediction of Myopia Progression Among School-Going Children 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priti Singh  
Designation  Additional Professor  
Affiliation  All India Institute of Medical Sciences, Bhopal  
Address  All India Institute of Medical Sciences, Bhopal
All India Institute of Medical Sciences, Saket Nagar Bhopal
Bhopal
MADHYA PRADESH
462020
India 
Phone  9993896479  
Fax    
Email  priti.ophtho@aiimsbhopal.edu.in   
 
Details of Contact Person
Scientific Query  
Name  Dr Priti Singh  
Designation  Additional Professor  
Affiliation  All India Institute of Medical Sciences, Bhopal  
Address  Department of Ophthalmology All India Institute of Medical Sciences, Bhopal
Department of Ophthalmology All India Institute of Medical Sciences, Saket Nagar Bhopal

MADHYA PRADESH
462020
India 
Phone  9993896479  
Fax    
Email  priti.ophtho@aiimsbhopal.edu.in   
 
Details of Contact Person
Public Query  
Name  Dr Priti Singh  
Designation  Additional Professor  
Affiliation  All India Institute of Medical Sciences, Bhopal  
Address  Department of Ophthalmology All India Institute of Medical Sciences, Bhopal
Department of Ophthalmology All India Institute of Medical Sciences, Saket Nagar Bhopal

MADHYA PRADESH
462020
India 
Phone  9993896479  
Fax    
Email  priti.ophtho@aiimsbhopal.edu.in   
 
Source of Monetary or Material Support  
Indian Council of Medical Research (ICMR) Address: Indian Council of Medical Research (ICMR), V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi – 110029, Country: India Pincode: 110029 
 
Primary Sponsor  
Name  Indian Council of Medical Research (ICMR)  
Address  V. Ramalingaswami Bhawan, Post Box No. 4911, Ansari Nagar, New Delhi – 110029, India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Priti Singh   All India Institute of Medical Sciences (AIIMS), Bhopal State: Madhya Pradesh District: Bhopal  Department of Ophthalmology, 3rd Floor, OPD Block, All India Institute of Medical Sciences (AIIMS), Saket Nagar, Bhopal – 462020, Madhya Pradesh, India
Bhopal
MADHYA PRADESH 		 91-9993896479

priti.ophtho@aiimsbhopal.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical comittee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H521||Myopia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil   AI model trained using ocular, behavioral, and environmental data (e.g., axial length, screen time, parental myopia) to predict myopia progression. No therapeutic intervention administered. 
Intervention  Nil  This is a non-interventional, single-arm observational study. No control or comparator agent is used. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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 baselin 		 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 Outcome  
Outcome  TimePoints 

AI Model Performance Metrics – Accuracy, Sensitivity, Specificity, AUROC, F1 Score

 
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)

 		 At end of Phase 1 (Baseline cross-sectional analysis) 
Validation Accuracy of Mobile Application Predictions vs. clinical diagnoses (Positive Predictive Value, Kappa score)

 		 18 and 24 months (during pilot testing of the mobile app) 
Awareness and Behavior Change Metrics – Number of children reached, engagement in prevention programs

 
Ongoing throughout study; evaluated cumulatively at 12, 18, and 24 months 
 
Target Sample Size   Total Sample Size="12000"
Sample Size from India="12000" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  De-identified participant-level data and statistical code will be made available for academic research purposes upon reasonable request. Proposals should be directed to priti.ophtho@aiimsbhopal.edu.in. To gain access, requestors will be required to sign a Data Access Agreement. Data will be made available for 5 years via an institutional repository or a third-party academic platform. Link to be provided upon acceptance of data sharing request.

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This study aims to develop and validate an Artificial Intelligence (AI) based predictive model for assessing myopia progression among school-going children aged 6 to 18 years in urban and rural areas of the Bhopal Division, India. The research will be conducted in two phases. Phase one involves a cross-sectional survey of approximately 12000 children to collect ocular, demographic, and behavioral data such as axial length, refractive status, screen time, and outdoor activity. Phase two will follow a stratified 10 percent cohort of these children longitudinally every six months over two years to track changes in spherical equivalent refraction and axial length. Using this data, machine learning models including linear regression, support vector machines, XGBoost, and convolutional neural networks will be trained to predict the risk of myopia progression. The validated AI model will be integrated into a mobile application for field-level screening and early identification of at-risk children. The study also includes awareness initiatives on preventive eye care and aims to establish a large-scale Indian dataset to support policy planning and public health strategies for pediatric vision health.

 
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