| 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
|
|
|
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
|
|
|
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
|
|
|
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. |