| CTRI Number |
CTRI/2014/07/004733 [Registered on: 11/07/2014] Trial Registered Retrospectively |
| Last Modified On: |
11/07/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
|
| Study Design |
Other |
|
Public Title of Study
|
study on infective causes of corneal ulcers and the treatment outcome in a tertiary care centre |
|
Scientific Title of Study
|
Prospective Study of Microbiological Diagnosis and Treatment Outcome of 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 Sukumar T K |
| Designation |
PG Resident |
| Affiliation |
Father Muller Medical College |
| Address |
Department of Microbiology
Father Muller Medical College
Fr Muller Road
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8904518338 |
| Fax |
|
| Email |
sukumartk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rekha B |
| Designation |
Professor and HOD |
| Affiliation |
father muller medical college |
| Address |
Department of Microbiology
Father Muller Medical College
Fr Muller Road
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
|
| Fax |
|
| Email |
rekhaboloor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rekha B |
| Designation |
Professor and HOD |
| Affiliation |
father muller medical college |
| Address |
Department of Microbiology
Father Muller Medical College
Fr Muller Road
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
|
| Fax |
|
| Email |
rekhaboloor@gmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical College |
|
|
Primary Sponsor
|
| Name |
Father Muller Medical College |
| Address |
Father Muller Medical College
Fr Muller Road
Kankanady
Mangalore - 575002 |
| 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 Sukumar T K |
Central Lab - Father Muller Medical College |
Father Muller Medical College
Central Lab, Microbiology Lab
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA |
8904518338
sukumartk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with Corneal Ulcers suspected by the ophthalmologists to be of microbial etiology., |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients with corneal ulcer suspected by the ophthalmologists as of microbial etiology. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of various causes of keratitis in Mangalore |
1year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Treatment Outcome of keratitis |
1year |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/01/2014 |
| 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) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Keratitis is a term used for inflammation of the cornea. Corneal pathologies are known to be second most common cause of uniocular blindness in some developing countries. Microbial keratitis might be caused by a bacteria, fungus, virus or a parasite. The etiological and epidemiological pattern seems to vary from time to time, patient population, geographic location and health of the cornea. The objectives of this study is to determine the epidemiological characteristics and microbiological profile of keratitis in a tertiary care centre in Mangalore. Also to determine the treatment outcome of suspected microbial keratitis cases. |