| CTRI Number |
CTRI/2025/08/092693 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
A Hospital Based Prospective Study |
| Study Design |
Other |
|
Public Title of Study
|
Common Causes And Microorganisms Causing Corneal Infections In A Population. |
|
Scientific Title of Study
|
DEMOGRAPHIC DISTRIBUTION AND MICROBIOLOGICAL PROFILE OF MICROBIAL KERATITIS: A PROSPECTIVE HOSPITAL-BASED STUDY |
| 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 Pankhuri Singhal |
| Designation |
DNB PG Student |
| Affiliation |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital,
Guest House, Ground Floor Village Panau Purwa, Off Gt Road, Amiliha, PO, Tatiyaganj, Uttar Pradesh 209217
Kanpur Nagar
UTTAR PRADESH
209217
India |
| Phone |
9927144488 |
| Fax |
|
| Email |
pankhuri.singhal7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharad Kumar Mishra |
| Designation |
Consultant |
| Affiliation |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital,
OPD Room No.10 Village Panau Purwa, Off Gt Road, Amiliha, PO, Tatiyaganj, Uttar Pradesh 209217
Kanpur Nagar
UTTAR PRADESH
209217
India |
| Phone |
9598817715 |
| Fax |
|
| Email |
sharadkumarmishra@sankaraeye.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharad Kumar Mishra |
| Designation |
Consultant |
| Affiliation |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital,
OPD Room No.10 Village Panau Purwa, Off Gt Road, Amiliha, PO, Tatiyaganj, Uttar Pradesh 209217
Kanpur Nagar
UTTAR PRADESH
209217
India |
| Phone |
9598817715 |
| Fax |
|
| Email |
sharadkumarmishra@sankaraeye.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital, kanpur |
|
|
Primary Sponsor
|
| Name |
Dr Pankhuri Singhal |
| Address |
Sankara Eye Hospital,
Guest House, Ground Floor Village Panau Purwa, Off Gt Road, Amiliha, PO, Tatiyaganj, Uttar Pradesh 209217 |
| Type of Sponsor |
Other [Self ] |
|
|
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 Pankhuri Singhal |
Sankara Eye Hospital |
Sankara Eye Hospital,Ground Floor, OPD Room no 13,
Village Panau Purwa, Off Gt Road, Amiliha, PO, Tatiyaganj, Uttar Pradesh 209217
Kanpur Nagar
UTTAR PRADESH |
9927144488
pankhuri.singhal7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE- SANKARA EYE HOSPITAL KANPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H160||Corneal ulcer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both gender and all age
group, who will be clinically diagnosed as cases of infectious corneal ulcer after thorough clinical evaluation.
|
|
| ExclusionCriteria |
| Details |
1.Viral Dendritic ulcers
2.Perforated ulcers
3.Ulcers less than 1 mm
4.Uncooperative patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comprehensive analysis of the demographic distribution and microbiological profile of infectious keratitis. |
1. KOH AND GRAM STAIN REPORTING ON THE DAY OF CORNEAL SCRAPING WHICH WILL BE AFTER 48 HOURS OF FIRST VISIT IN OPD.
2. BACTERIAL CULTURE REPORT WILL BE TAKEN AFTER 48 HOURS OF THE SAMPLE INOCULATION.
3. FUNGAL CULTURE REPORT WILL BE TAKEN WITHIN 7 TO 21 DAYS OF SAMPLE INOCULATION.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="95"
Sample Size from India="95"
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)
|
10/08/2025 |
| 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="1"
Months="6"
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 study aims to conduct a comprehensive analysis of the demographic distribution and microbiological profile of infectious keratitis, with a focus on identifying predominant pathogens and associated risk factors within the region. My study involves recruiting patients who meet the inclusion/exclusion criteria after obtaining informed consent and ethics approval. A detailed patient history, including demographics, complaints, prior treatments, trauma, and systemic conditions, is taken. Clinical examination includes visual acuity, external ocular inspection, and slit-lamp evaluation. Corneal scraping is performed after a 48-hour drug holiday, with samples sent for microscopy for Gram stain, KOH and cultured on Blood Agar and Sabouraud Dextrose Agar. Cultures are incubated for up to three weeks. Based on results, appropriate treatment is initiated. |