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
|
|
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
|
|
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. |