| CTRI Number |
CTRI/2025/08/092927 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study in north indian population that evaluates clinical and cellular findings of stem cell deficiency in the limbus in allergic keratoconjuctivitis patients |
|
Scientific Title of Study
|
Clinical And Cytological Findings Of Limbal Stem Cell Deficiency In Vernal Keratoconjuctivitis Patients: A Prospective Study In North Indian Population |
| 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 Paridhi Gupta |
| Designation |
Post Graduate Resident |
| Affiliation |
Krishna Mohan Medical College and Hospital |
| Address |
Department of Ophthalmology,
Krishna Mohan Medical College and Hospital,
Pali Dungra,
Sonkh Road,
Mathura,
Uttar Pradesh
Mathura
UTTAR PRADESH
281123
India |
| Phone |
8077484057 |
| Fax |
|
| Email |
paridhigupta251@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mukesh Kumar Taneja |
| Designation |
H.O.D. and Professor |
| Affiliation |
Krishna Mohan Medical College and Hospital |
| Address |
Department of Ophthalmology,
Krishna Mohan Medical College and Hospital,
Pali Dungra,
Sonkh Road,
Mathura,
Uttar Pradesh
Mathura
UTTAR PRADESH
281123
India |
| Phone |
8439839037 |
| Fax |
|
| Email |
mktaneja50@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Paridhi Gupta |
| Designation |
Post Graduate Resident |
| Affiliation |
Krishna Mohan Medical College and Hospital |
| Address |
Department of Ophthalmology,
Krishna Mohan Medical College and Hospital,
Pali Dungra,
Sonkh Road,
Mathura,
Uttar Pradesh
UTTAR PRADESH
281123
India |
| Phone |
8077484057 |
| Fax |
|
| Email |
paridhigupta251@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Ophthalmology,
Krishna Mohan Medical College and Hospital,
Pali Dungra,
Sonkh Road,
Mathura,
Uttar Pradesh, India
Pin code- 281123
|
|
|
Primary Sponsor
|
| Name |
Krishna Mohan Medical College and Hospital |
| Address |
Department of Ophthalmology,
Krishna Mohan Medical College and Hospital,
Pali Dungra,
Sonkh Road,
Mathura,
Uttar Pradesh, India
Pin Code - 281123 |
| Type of Sponsor |
Private medical college |
|
|
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 PARIDHI GUPTA |
Krishna Mohan Medical College and Hospital |
Department of Ophthalmology,
Krishna Mohan Medical College and Hospital,
Pali Dungra,
Sonkh Road,
Mathura,
Uttar Pradesh
Mathura
UTTAR PRADESH |
8077484057
paridhigupta251@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| K.M. UNIVERSITY INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H162||Keratoconjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
Patient diagnosed for VKC in one or both eyes.
|
|
| ExclusionCriteria |
| Details |
Patients with active shields ulcer.
Patients with chemical/thermal injury, erythema multiforme or chronic contact lens wear.
Dry eye Disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Conjuctival Congestion
Foreign Body Sensation |
same day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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="0"
Months="8"
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 prospective comparative study evaluates limbal involvement and limbal stem cell deficiency (LSCD) in patients with vernal keratoconjunctivitis (VKC). VKC is a chronic allergic inflammatory disorder affecting the ocular surface, primarily in children and young adults, often leading to corneal damage and visual impairment. The study will be conducted over 8 months and includes 96 eyes—46 with clinically diagnosed LSCD as cases and 46 without LSCD as controls. Diagnosis will be confirmed using clinical signs and impression cytology. Clinical findings such as limbal pigmentation, corneal conjunctivalization, and loss of palisades of Vogt and cytology showing increased goblet cells at corneal surface, squamous cell metaplasia and inflammatory cells helps in diagnosing LSCD. The study aims to correlate clinical and cytological findings in VKC, helping in early diagnosis, severity assessment, and guiding management to prevent long-term complications. |