| 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
|
|
|
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
|
|
|
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
|
|
|
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. |