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CTRI Number  CTRI/2024/08/072121 [Registered on: 08/08/2024] Trial Registered Prospectively
Last Modified On: 25/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Retrospective 
Study Design  Other 
Public Title of Study   Patterns of Refractive Error in Children Based on School Screening in Rural Karnataka 
Scientific Title of Study   Patterns of Refractive Error in Pediatric Population Based on School Screening in Rural Karnataka 
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 Sruthi Vijendran 
Designation  Senior Resident  
Affiliation  Kasturba Medical College Manipal MAHE Manipal 
Address  Department of Ophthalmology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  9535230750  
Fax    
Email  drsruthi.vijendran@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Yogish S Kamath 
Designation  Professor and Head of Department  
Affiliation  Kasturba Medical College Manipal, Manipal Academy of Higher Education, Manipal 
Address  Department of Ophthalmology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  9535230750  
Fax    
Email  yogish.kamath@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Sruthi Vijendran 
Designation  Senior Resident  
Affiliation  Kasturba Medical College Manipal MAHE Manipal 
Address  Department of Ophthalmology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal Karnataka 576104


KARNATAKA
576104
India 
Phone  9535230750  
Fax    
Email  drsruthi.vijendran@gmail.com  
 
Source of Monetary or Material Support  
Department of Ophthalmology, Kasturba Medical College Manipal, Karnataka, India 576104 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Sruthi Vijendran  Kasturba Medical College Manipal  Department of Ophthalmology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal Karnataka 576104
Udupi
KARNATAKA 		 9535230750

drsruthi.vijendran@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H545||Low vision, one eye,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  1. The already recorded data of students aged between 4 to 16 years who attended the school screening camp organized by Kasturba Medical College in Shringeri taluk, Chikamagaluru district, and Agumbe, and Thirthahalli taluk of Shimoga district, Karnataka will be tabulated and analysed.
2.Records of Children of both genders will be recorded.
3.All ocular disorders which could be diagnosed with the Snellen visual acuity test, torchlight anterior segment evaluation, and undilated fundus evaluation will be recorded. 
 
ExclusionCriteria 
Details  1)Those whose parents/guardians did not consent to taking part in the school screening camp
2)Children who were unwell to participate in the school screening camp.
3)Records of children who presented at the hospital for screening and not at the school eye health camp were excluded 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The prevalence of refractive error and other eye diseases and the socio- demographic profiling of students with refractive error.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="2137"
Sample Size from India="2137" 
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)   20/08/2024 
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 Yet Recruiting 
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 - 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 - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drsruthi.vijendran@gmail.com].

  6. For how long will this data be available start date provided 19-09-2024 and end date provided 19-09-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
The prevalence of refractive error, one of the important causes of visual impairment is lesser studied in the Western Ghat districts of Chikmagalur and Shimoga. This retrospective cross sectional study aims to determine the pattern of refractive error among the students in this region.
School screening records between July to December 2022 of 2137 children aged 4 to 16 years will be chosen. Demographic details, visual acuity, vision screener PlusoptiX A09 values and anterior segment torchlight evaluation details will be documented with details of referral.The prevalence of refractive error and other eye diseases and the socio- demographic profiling of students with refractive error will be analysed.
 
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