| CTRI Number |
CTRI/2022/01/039611 [Registered on: 20/01/2022] Trial Registered Prospectively |
| Last Modified On: |
19/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Tear Film Studies In Children With Vernal Keratoconjunctivitis |
|
Scientific Title of Study
|
Tear Film Studies In Vernal Keratoconjunctivitis In Pediatric Population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruchi Gupta |
| Designation |
Post Graduate resident |
| Affiliation |
Maulana Azad Medical College and associated Guru Nanak Eye Center |
| Address |
Room No. 16, OPD Block
Guru Nanak Eye Center,
Maharaja Ranjit Singh Marg
New Delhi 110002
Central
DELHI
110002
India |
| Phone |
9818260422 |
| Fax |
|
| Email |
ophtha.ruchigupta.2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ritu Arora |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Dean office, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9968604331 |
| Fax |
|
| Email |
dr_rituarora@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritu Arora |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Dean office, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9968604331 |
| Fax |
|
| Email |
dr_rituarora@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College And Associated Guru Nanak Eye Center, New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Department of Ophthalmology |
| Address |
Maulana Azad Medical College and associated Guru Nanak Eye Center, New Delhi 110002 |
| Type of Sponsor |
Government 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 Ruchi Gupta |
Guru Nanak Eye Center |
Room No. 16
OPD Block,
Guru Nanak Eye Center,
Maharaja Ranjit Singh Marg,
New Delhi 110002
Central
DELHI |
9818260422
ophtha.ruchigupta.2020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, MAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
children presenting for refraction with no ocular surface problems |
| Patients |
(1) ICD-10 Condition: H162||Keratoconjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. CASES: Patients with vernal keratoconjunctivitis on no treatment or only on mast cell stabilisers
Children of 4 to 18 years of age presenting to the OPD with moderate to severe ocular discomfort (itching, photophobia, foreign body sensation, discharge, burning), papillae on upper tarsal conjunctiva or Horner Tranta dots on the limbus.
2. CONTROLS: Children of 4 to 18 years of age attending the OPD for refraction tests with no ocular surface problems.
|
|
| ExclusionCriteria |
| Details |
1. Patients of vernal keratoconjunctivitis on treatment with steroids or lubricant drops
2. Vernal keratoconjunctivitis with accompanying shield ulcer
3. Ocular diseases like blepharitis, active ocular infections, lid abnormalities
4. Chemical, thermal or radiation injury to eye
5. Systemic diseases (other than atopy)
6. History of Steven Johnson syndrome
7. Previous ophthalmic surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Measurement of parameters related to tear film stability.
• Schirmer test
• Tear film break up time
• Lissamine green stain
• Meibomian gland drop-out
|
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
31/01/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Vernal Keratoconjunctivitis (VKC) is a chronic, bilateral, at times asymmetrical, seasonally
exacerbated allergic inflammation of the ocular surface involving the tarsal and/or bulbar
conjunctiva. This is a cross sectional study to investigate the alterations in tear film stability in patients with
vernal keratoconjunctivitis using tests for dry eye and meibography and to compare the results
with healthy controls. The outcome parameters measured will be parameters related to tear film stability: Schirmer test ,Tear film break up time , Lissamine green stain , Meibomian gland drop-out. |