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CTRI Number  CTRI/2025/02/080625 [Registered on: 14/02/2025] Trial Registered Prospectively
Last Modified On: 06/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   How Common Eye Problems Affect School Performance in High School Students 
Scientific Title of Study   Prevalence of refractive error and its impact on academic performance of high school children 14-16 Years in urban population of belagavi district 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aswini S 
Designation  Postgraduate 
Affiliation  Jawaharlal Nehru Medical College, KLE University 
Address  KAHER, Jawaharlal Nehru Medical College, KLE University, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  8148766318  
Fax    
Email  ezhilaswini18@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Umesh S Charantimath 
Designation  Associate Professor 
Affiliation  Department of Community Medicine, KAHER, Jawaharlal Nehru Medical College 
Address  Department of Community Medicine, KAHER, Jawaharlal Nehru Medical College, KLE University, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9663712777  
Fax    
Email  Drumeshscharantimath@jnmc.edu  
 
Details of Contact Person
Public Query
 
Name  Umesh S Charantimath 
Designation  Associate Professor 
Affiliation   
Address  Department of Community Medicine, KAHER, JNMC, KLE University, Nehru Nagar, Belagavi
Department of Community Medicine, KAHER, Jawaharlal Nehru Medical College
Belgaum
KARNATAKA
590010
India 
Phone  9663712777  
Fax    
Email  Drumeshscharantimath@jnmc.edu  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical College, KAHER, KLE University, Belagavi-590010 Karnataka, India 
 
Primary Sponsor  
Name  Aswini S 
Address  Jawaharlal Nehru Medical College, KAHER, KLE University, Belagavi-590010 Karnataka, India 
Type of Sponsor  Other [Self] 
 
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 S Aswini   Jawaharlal Nehru Medical College, KAHER, KLE University  Department of Community Medicine, Nehru Nagar, Belagavi
Belgaum
KARNATAKA 
8148766318

ezhilaswini18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Refractive Error And Its Impact On Their Academic Performance 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  1. High school students of 8th to 10th standard of urban area of belagavi district
2. Parents of students willing to provide information 
 
ExclusionCriteria 
Details  Students who have undergone any eye surgery or any history of injury to eye will be excluded 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of Refractive Error among high school children aged 14-16 years in urban areas of Belagavi district  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Impact of visual impairment on academic performance of the school children  1 year 
 
Target Sample Size   Total Sample Size="550"
Sample Size from India="550" 
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)   01/03/2025 
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)   Not Applicable 
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 - NO
Brief Summary  

Title: Prevalence of Refractive Error and its Impact on Academic Performance of High School Children (14-16 years) in Urban Population of Belagavi District

Introduction:
Visual impairment, primarily caused by refractive errors, is a major public health issue, especially in developing countries. Poor vision significantly affects academic performance and social development in children. This study aims to assess the prevalence of refractive error and its impact on academic performance among high school students.

Objectives:

  1. To determine the prevalence of refractive error among 14–16-year-old school children.
  2. To evaluate the impact of visual impairment on academic performance.

Methodology:
A cross-sectional study will be conducted from March 2025 to Feb 2026, involving 550 students from 8 schools in urban Belagavi. Students from grades 8–10 will be selected through stratified random sampling. Data collection includes sociodemographic details, visual acuity tests (Snellen’s chart), and academic performance assessed through scorecards. Anthropometric measurements and knowledge-attitude-practice (KAP) surveys on eye health will also be conducted. Data will be analyzed using SPSS software.

Expected Outcome:
The study will provide insights into untreated visual problems, their association with school performance, and the need for regular vision screenings in schools to improve academic outcomes.

Significance:
Findings will help design targeted interventions for early detection and correction of refractive errors, ultimately enhancing children’s academic performance and quality of life.

 
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