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CTRI Number  CTRI/2025/06/088391 [Registered on: 06/06/2025] Trial Registered Prospectively
Last Modified On: 31/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A study comparing vision problems in children with and without headaches. 
Scientific Title of Study   Comparative Analysis of Binocular Vision Anomalies in Pediatric Patients with and without Haedaches:An observational Study 
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 Siddhi Rajendra Shinde 
Designation  Postgraduate DNB Resident 
Affiliation  Aravind Eye Hospital, Pondicherry  
Address  Room number 12, Ground Floor, Paediatric and Squint Clinic, Aravind Eye Hospital, Pondicherry, Cuddalore Main Road, Thavalakuppam, Pondicherry, India 605007

Pondicherry
PONDICHERRY
605007
India 
Phone  7038785507  
Fax    
Email  siddhirshinde77@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anjali Khadia  
Designation  Medical Consultant 
Affiliation  Aravind Eye Hospital, Pondicherry 
Address  Room number 12, Ground Floor, Paediatric and Squint Clinic, Aravind Eye Hospital, Pondicherry, Cuddalore Main Road, Thavalakuppam, Pondicherry, India 605007

Pondicherry
PONDICHERRY
605007
India 
Phone  8838217883  
Fax    
Email  anjali.khadia@aravind.org  
 
Details of Contact Person
Public Query
 
Name  Dr Siddhi Rajendra Shinde 
Designation  Postgraduate DNB Resident 
Affiliation  siddhirshinde77@gmail.com 
Address  Room number 12, Ground Floor, Paediatric and Squint Clinic, Aravind Eye Hospital, Pondicherry, Cuddalore Main Road, Thavalakuppam, Pondicherry, India 605007

Pondicherry
PONDICHERRY
605007
India 
Phone  7038785507  
Fax    
Email  siddhirshinde77@gmail.com  
 
Source of Monetary or Material Support  
Aravind Eye Hospital,Cuddalore Main Road, Thavalkuppam, Pondicherry, India, 605007 
 
Primary Sponsor  
Name  Aravind Eye Hospital,Pondicherry 
Address  Room No.12, Paediatric Department,Aravind Eye Hospital,Cuddalore Main Road, Thavalkuppam, Pondicherry, India, 605007 
Type of Sponsor  Research institution and hospital 
 
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 Siddhi Rajendra Shinde  Aravind Eye Hospital, Pondicherry  Room No. 12, Ground Floor, Paediatric and Squint Clinic, Aravind Eye Hospital,Pondicherry, Cuddalore Main road, Thavalakuppam, India, 605007
Pondicherry
PONDICHERRY 
7038785507

siddhirshinde77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Aravind Eye Hospital, Pondicherry  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Age matched healthy controls  
Patients  (1) ICD-10 Condition: H519||Unspecified disorder of binocularmovement,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children aged 8 to 18 years with a visual acuity of 6 by 6
Presenting with complaints of headache
AND
Age-matched children without headache 
 
ExclusionCriteria 
Details  Exclusion criteria
Children with
1 Refractive errors
2 Manifest strabismus
3 Anterior and posterior segment disorders
4 Head injury
5 Intellectual disability
6 Multiple systemic disabilities 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The study will help identify the differences in binocular vision parameters of children with
and without headache. 
At the time of presentation. 
 
Secondary Outcome  
Outcome  TimePoints 
These findings will aid in clinical evaluation and management.  At the time of presentation. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   16/06/2025 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

This cross-sectional observational study aims to evaluate and compare binocular vision parameters in children aged 8 to 18 years presenting with headaches and those without. Headache in children is a common complaint, and its association with binocular vision anomalies remains under-recognized in clinical practice. This study seeks to identify specific binocular vision deficits among symptomatic children using a structured BVA protocol, thereby facilitating earlier diagnosis and targeted intervention.

The study will be conducted at a tertiary eye care center in South India, with participants recruited from pediatric ophthalmology and optometry outpatient clinics. Children will undergo comprehensive orthoptic and binocular vision assessments, including tests for accommodation, vergence, and ocular motility. Participants will be categorized into two groups based on the presence or absence of headaches, and intergroup comparisons will be made to identify statistically significant differences.

The findings of this study are expected to enhance the understanding of functional visual contributions to pediatric headaches and support the incorporation of binocular vision screening in routine eye exams for children with such complaints.

 
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