| 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
|
|
|
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
|
|
|
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: - To determine the prevalence of refractive error among 14–16-year-old school children.
- 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. |