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CTRI Number  CTRI/2025/08/092313 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 24/12/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   School screening program (SSP), Sundargarh 
Scientific Title of Study   Comprehensive eye health program to screen children for vision impairment and refractive errors in Sundargarh District, Odisha, India. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Debasmita Majhi 
Designation  Consultant Ophthalmologist, Pediatric Ophthalmology, Strabismus and Neuro-Ophthalmology 
Affiliation  L V Prasad Eye Institute 
Address  L V Prasad Eye Institute, Mithu Tulsi Chanrai Campus, Pediatric Ophthalmology Department, Patia, Bhubaneswar

Khordha
ORISSA
751024
India 
Phone  7381430348  
Fax    
Email  drdebasmita@lvpei.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Debasmita Majhi 
Designation  Consultant Ophthalmologist, Pediatric Ophthalmology, Strabismus and Neuro-Ophthalmology 
Affiliation  L V Prasad Eye Institute 
Address  L V Prasad Eye Institute, Mithu Tulsi Chanrai Campus, Pediatric Ophthalmology Department, Patia, Bhubaneswar

Khordha
ORISSA
751024
India 
Phone  7381430348  
Fax    
Email  drdebasmita@lvpei.org  
 
Details of Contact Person
Public Query
 
Name  Dr Debasmita Majhi 
Designation  Consultant Ophthalmologist, Pediatric Ophthalmology, Strabismus and Neuro-Ophthalmology 
Affiliation  L V Prasad Eye Institute 
Address  L V Prasad Eye Institute, Mithu Tulsi Chanrai Campus, Pediatric Ophthalmology Department, Patia, Bhubaneswar

Khordha
ORISSA
751024
India 
Phone  7381430348  
Fax    
Email  drdebasmita@lvpei.org  
 
Source of Monetary or Material Support  
Vision Aid Inc.8 Vine Brook, Rd Lexington, MA, 02421 
 
Primary Sponsor  
Name  Vision Aid 
Address  Inc.8 Vine Brook, Rd Lexington, MA, 02421 
Type of Sponsor  Other [Non Profit Organization] 
 
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 Debasmita Majhi  L V Prasad Eye Institute  Dalmia OCL Eye Center,Pediatric Ophthalmology Department, Sambalpur - Rourkela Hwy, Ranibandh Bijbon, Odisha, 770017
Sundargarh
ORISSA 
7381430348

drdebasmita@lvpei.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  All vulnerable children age group under 0-15 attending Anganwadi, day care/preschools, mainstream schools and special school in Sundargarh district, Odisha, India 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  All children attending Anganwadi, day care/preschools, mainstream schools & special schools in Sundargarh district, Odisha, India. 
 
ExclusionCriteria 
Details  –Schools not giving consent to participate. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To conduct school eye health programs in mainstream schools between (June 2025 – May 2026).

2. To provide refractive correction for free of charge for all those who are found to have refractive errors

3. To provide referral services for all children who require medical, surgical and vision rehabilitation services 
One year 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="50000"
Sample Size from India="50000" 
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)   18/08/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
This will be a prospective, community-based, cross-sectional study of a comprehensive eye health program aimed at screening children for vision impairment and refractive errors in Sundargarh District, Odisha, India.

The study will commence only after receiving IEC approval.

Rationale for the present study: 

School eye health programs effectively reach a larger number of children and offer opportunities to identify and intervene in sight-threatening eye conditions. This project aims to screen children attending Anganwadi centers, daycare/preschools, and mainstream schools in Sundargarh district, Odisha, India.

All children attending Anganwadi centers, daycare/preschools, and mainstream schools in Sundargarh district will be included.

Schools that do not permit or have not consented to participation will be excluded.

Study Procedure
After obtaining informed consent from parents and assent from children, and approval from the head authorities of the premises, the study will begin.

a) Trained field workers will screen children’s vision using E-cards and the Snellen chart, while classroom teachers will help identify visual issues such as glare sensitivity, squinting, nystagmus, and difficulty seeing or copying from the board.

b) Secondary screening and detailed assessment include: 1. Auto-refractor, 2. Trial frames and lenses for subjective correction, and 3. Retinoscope for further confirmation.

c) Spectacle prescription and dispensation.

d) Spectacle delivery by a field worker.

e) Teacher orientation: Teachers will be trained to observe, refer, and keep records of students’ compliance with spectacle use.

f) Regular follow-ups will be conducted by field workers to ensure ongoing spectacle use.

g) Children with complex conditions requiring medical or surgical intervention will be referred to secondary centers.
 
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