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CTRI Number  CTRI/2025/08/092447 [Registered on: 05/08/2025] Trial Registered Prospectively
Last Modified On: 04/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Study of mapping of layer of eye known as cornea in Children with disease named as Vernal Keratoconjuctivitis 
Scientific Title of Study   Corneal Topographical changes in Vernal Keratoconjunctivitis Among Paediatric age group Attending to Eye OPD, Dr. Sushila Tiwari Hospital, Haldwani 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aishwarya Talwalkar 
Designation  Post Graduate Resident 
Affiliation  Government Medical College, Dr. Sushila Tiwari Government Hospital, Haldwani 
Address  Department of Ophthalmology, Government Medical College, Dr. Sushila Tiwari Government Hospital, Haldwani

Nainital
UTTARANCHAL
263139
India 
Phone  8425948865  
Fax    
Email  aishut718@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nitin Mehrotra 
Designation  ASSOCIATE PROFESSOR  
Affiliation  Government Medical College, Dr. Sushila Tiwari Government Hospital, Haldwani 
Address  Department of Ophthalmology, Government Medical College, Dr. Sushila Tiwari Government Hospital, Haldwani

Nainital
UTTARANCHAL
263139
India 
Phone  9719639500  
Fax    
Email  drnitinmehrotra@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nitin Mehrotra 
Designation  ASSOCIATE PROFESSOR  
Affiliation  Government Medical College, Dr. Sushila Tiwari Government Hospital, Haldwani 
Address  Department of Ophthalmology, Government Medical College, Dr. Sushila Tiwari Government Hospital, Haldwani


UTTARANCHAL
263139
India 
Phone  9719639500  
Fax    
Email  drnitinmehrotra@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Aishwarya Talwalkar 
Address  Department of Ophthalmology, Government Medical College, Dr. Sushila Tiwari Government Hospital, Haldwani. 
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 
Aishwarya Talwalkar  Dr. Sushila Tiwari Government hospital, Haldwani  OPD of Ophthalmology,Dr. Sushila Tiwari Government hospital, Haldwani
Nainital
UTTARANCHAL 
8425948865

aishut718@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H183||Changes of corneal membranes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Patient having Vernal keratoconjunctivitis (VKC)  
 
ExclusionCriteria 
Details  1. Patient with ocular or systemic disease.
2. Patient or guardian who will not be willing for the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Determine corneal topographical changes among Pediatric age group with Vernal Keratoconjunctivitis  At Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To Assess pattern of refractive error in Vernal Keratoconjunctivitis patients  At Baseline 
 
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)   25/08/2025 
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="6"
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  

This cross-sectional, observational study aims to assess corneal topographical changes in children aged 3–18 years diagnosed with Vernal Keratoconjunctivitis (VKC) who are attending the Eye Outpatient Department of Dr. Sushila Tiwari Hospital, Haldwani. Over an 18-month period, all eligible VKC patients will be enrolled using complete enumeration. VKC, a chronic allergic ocular condition common in the pediatric population, often leads to significant changes in corneal structure that may predispose individuals to conditions like keratoconus and permanent visual impairment if not detected and managed early.

Detailed ophthalmological examinations—including corneal topography, curvature mapping, and pachymetry—will be performed to identify and characterize both overt and subtle corneal changes, with a special focus on screening for early keratoconus and subclinical cases. The aim is to determine the prevalence, extent, and types of corneal involvement associated with pediatric VKC within the Kumaon region, providing valuable epidemiological and clinical insights where such data are currently lacking.

By highlighting patterns and early alterations in corneal morphology, this study seeks to improve early diagnosis and management, thereby helping to prevent long-term vision loss in affected children. The research is conducted under the supervision of experienced ophthalmology faculty at Government Medical College, Haldwani, ensuring methodological and clinical rigor. The outcomes are expected to inform clinical practice, reinforce the value of routine corneal assessment in VKC, and support the development of effective regional management protocols for pediatric patients.


 
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