| CTRI Number |
CTRI/2020/04/024753 [Registered on: 21/04/2020] Trial Registered Prospectively |
| Last Modified On: |
17/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
As infective keratitis is a common public health problem,this study aims to finf the number of people suffering from the disease in a period of time and to study the factors responsible for the disease |
|
Scientific Title of Study
|
Epidemiology and clinico-microbiological profile of infective keratitis in a tertiary care hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Jindal |
| Designation |
Junior Resident |
| Affiliation |
Department of Ophthalmology Government medical College and hospital sector-32 |
| Address |
Department of Ophthalmology
Government medical College and hospital sector-32
Department of Ophthalmology
Government medical College and hospital sector-32
Chandigarh
CHANDIGARH
160032
India |
| Phone |
8930344593 |
| Fax |
|
| Email |
poojajindal227@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudesh Kumar Arya |
| Designation |
Professor |
| Affiliation |
Department of Ophthalmology Government medical College and hospital sector-32 |
| Address |
Department of Ophthalmology
Government medical College and hospital sector-32
Chandigarh
CHANDIGARH
160032
India |
| Phone |
|
| Fax |
|
| Email |
aryasudesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja jindal |
| Designation |
Junior resident |
| Affiliation |
Department of Ophthalmology Government medical College and hospital sector-32 |
| Address |
Department of Ophthalmology
Government medical College and hospital sector-32
Chandigarh
CHANDIGARH
110033
India |
| Phone |
09310272886 |
| Fax |
|
| Email |
poojajindal227@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Ophthalmology
Government medical College and hospital sector-32 |
|
|
Primary Sponsor
|
| Name |
Government medical College and hospital sector |
| Address |
Department of Ophthalmology
Government medical College and hospital sector-32 |
| 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 Pooja jindal |
Government medical College and hospital sector-32 |
Department of Ophthalmology
Government medical College and hospital sector-32
Chandigarh
CHANDIGARH |
8930344593
poojajindal227@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee Government medical College and hospital sector-32 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H160||Corneal ulcer, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All consecutive patients coming to department of ophthalmology with clinically infective keratitis |
|
| ExclusionCriteria |
| Details |
Patients presenting with typical viral ulcer, neurotrophic ulcer, neuroparalytic ulcer, atheromatous ulcer, any corneal ulcer clinically appearing to be of autoimmune origin. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Epidemiological profile of infective keratitis in a tertiary care hospital |
1 week, 2 weeks, 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinico-microbiological profile of infective keratitis in a tertiary care hospital |
1 week ,2 weeks , 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
28/04/2020 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study has been planned to find the incidence of infective keratitis in a tertiary care hospital and to study the clinical features and correlate them with the microbiological profile |