| CTRI Number |
CTRI/2025/07/092087 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare Eye Surface changes in people with and without Allergic Eye Disease. |
|
Scientific Title of Study
|
An observational control study to evaluate corneal topographic changes in patients with Allergic conjunctivitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRIYA SINGH |
| Designation |
DNB |
| Affiliation |
Bhaktivedanta Hospital and Research Institiute |
| Address |
OPD no 3, First floor, new building,Srishti complex, Bhaktivedanta Swami Marg,Miraroad(E)
Thane
MAHARASHTRA
401107
India |
| Phone |
9323155495 |
| Fax |
|
| Email |
priyasinghd9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr . Sapna kini |
| Designation |
MBBS,DNB, FCRS |
| Affiliation |
Bhaktivedanta Hospital and Research Institiute |
| Address |
OPD no 3, First floor, new building,Srishti complex, Bhaktivedanta Swami Marg,Miraroad(E), Thane, Maharashtra-401107,India
Thane
MAHARASHTRA
401107
India |
| Phone |
9867600143 |
| Fax |
|
| Email |
drsapnakini8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRIYA SINGH |
| Designation |
DNB |
| Affiliation |
Bhaktivedanta Hospital and Research Institiute |
| Address |
OPD no 3, First floor, new building,Srishti complex, Bhaktivedanta Swami Marg,Miraroad(E)
Thane
MAHARASHTRA
401107
India |
| Phone |
9323155495 |
| Fax |
|
| Email |
priyasinghd9@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bhaktivedanta Hospital and Research Institiute |
| Address |
Opd no 3,First floor,new building ,srishti complex,Bhaktivedanta Swami Marg,Miraroad(E),Thane,Maharashtra-401107, India |
| 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 Priya Singh |
Bhaktivedanta Hospital and Research Institute |
OPD no 3, First floor,new building,srishti complex,Bhaktivedanta Swami Marg,Miraroad (E),Thane ,Maharashtra-401107,India
Thane
MAHARASHTRA |
9323155495
priyasinghd9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhaktivedanta hospital Ethics committee for biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H104||Chronic conjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient having Allergic conjunctivitis aged between 7 to 30 years.
2. Patient with history of allergic conjunctivitis symptoms presisting more then 06 months
|
|
| ExclusionCriteria |
| Details |
1.Active ocular infection
2.Poor ocular surface disease
3.Previous history of corneal scars,Patient with other ocular or systemic diasese
4.High myopic Patient more than 6D, have ptosis or squint.
5.Patient with a history of previous ocular surgeries were excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in anterior and posterior corneal curvature
Identify early or subclinical keratoconus |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Astigmatism
Corneal thinning |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
11/08/2025 |
| 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="2"
Months="0"
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
|
The purpose of this study is to evaluate corneal topographic changes in patients with allergic conjunctivitis by scheimpflug imaging. The study will make us understand the impact of chronic eye rubbing on corneal curvature. The goal is to assess whether Allergic conjunctivitis induces corneal steepening,irregular astigmatism that could contribute to visual disturbance. By identifying corneal changes associated with allergic conjunctivitis,this study could aid in early detection of corneal irregularities,help to differentiate mimicking condition such as keratoconus,and contribute to better management strategies to prevent long term visual outcome.Insights may guide ophthalmologist in monitoring high- risk patients more closely.Patients who are diagnosed with allergic conjunctivitis will be recruited.It will be 2 group- Observational and control study( age and gender matched Individual) .Corneal topography will be done for the patients in both group free of cost unless required as per severity of condition and for long term monitoring of the same. Study will be done for various parameters as mentioned below and statistical analysis will be presented.
|