| CTRI Number |
CTRI/2025/05/086646 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
09/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A special membrane used to collect samples from the eye surface to test for corneal ulcers |
|
Scientific Title of Study
|
Corneal Impression Membrane (CIM) Sampling for Microbial Keratitis Diagnosis |
| Trial Acronym |
CIMS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Josephine Christy |
| Designation |
Head of the Department, Cornea |
| Affiliation |
Aravind Eye Hospital |
| Address |
Room No.25, Department of Cornea, Aravind Eye Hospital, Thavallakuppam
Pondicherry
PONDICHERRY
605007
India |
| Phone |
04132619100 |
| Fax |
|
| Email |
josephine@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Josephine Christy |
| Designation |
Head of the Department, Cornea |
| Affiliation |
Aravind Eye Hospital |
| Address |
Room No.25, Department of Cornea, Aravind Eye Hospital, Thavallakuppam
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9994549584 |
| Fax |
|
| Email |
josephine@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Josephine Christy |
| Designation |
Head of the Department, Cornea |
| Affiliation |
Aravind Eye Hospital |
| Address |
Room No.25, Department of Cornea, Aravind Eye Hospital, Thavallakuppam
Pondicherry
PONDICHERRY
605007
India |
| Phone |
04132619100 |
| Fax |
|
| Email |
josephine@aravind.org |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital, Pondicherry 605007 |
|
|
Primary Sponsor
|
| Name |
Aravind Eye Hospital |
| Address |
Aravind Eye Hospital Pondicherry
Thavalakuppam
Pondicherry 605007 |
| 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 |
| Josephine Christy |
Aravind Eye Hospital |
Room no 25, Department of Cornea, Thavalakuppam, Cuddalore road, Pondicherry, 605007
Pondicherry
PONDICHERRY |
04132619100
pdy.patientcare@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-AEH-P |
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 |
| Comparator Agent |
Conventional corneal scrpaing |
Under topical anaesthesia, a scraping blade will be used to obtain corneal samples for - a)Smear examination : Gram & KOH stain b) Culture in blood agar c)Culture in potato dextrose agar |
| Intervention |
Using corneal impression membrane for obtaining material for diagnostic investigations |
Under topical anaesthesia, corneal impression membrane will be used to obtain samples for - a)Smear examination : Gram & KOH stain b) Culture in Brain heart infusion broth c)For PCR |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Suspicion of Fungal Keratitis and
Undergoing routine corneal scraping for diagnostic purposes
|
|
| ExclusionCriteria |
| Details |
Suspected Viral, Acanthamoeba, Mixed Keratitis cases
Microbial Keratitis in both eyes
Perforated ulcer
Small ulcer of less than 3 mm |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To demonstrate at least 65% sensitivity of CIM in detecting fungal organisms, thereby proving a non-inferiority of CIM to conventional corneal scraping method.
To demonstrate that CIM collected specimens can be used for immediate identification of organisms by smear microscopy.
|
The microbiology positivity will be checked at Day 1, 3 days, 1 week and 2 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/06/2025 |
| 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="0"
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
|
Microbial keratitis remains a challenge to diagnose, with gold-standard culture often positive in <60% of cases. Moreover, smear microscopy positivity rates also suffer from low sensitivity. These poor outcomes are often attributed to very low pathogen levels within the collected samples, which are routinely collected by sharp instruments, such as a blade or needle. Since May 2017, Corneal Impression Membranes (CIMs) have replaced these sharp instruments as the gold-standard, sampling tool at St Pauls Eye Hospital in Liverpool, UK, and are now being more broadly adopted across major corneal departments in the UK. In Liverpool, it has been shown through both experimental and clinical studies that the CIMs reliably provide better microbiological diagnostic rates than a sharp instrument and/or a swab for bacterial keratitis (in Liverpool, culture positivity increased from 19.4% for scraped samples to 65.2% for samples collected by CIM (total 3099 corneal samples))1. The use of the CIM also results in a better patient experience compared to obtaining samples using a sharp instrument. In addition, it provides the opportunity to expand its usage among ophthalmic technicians in primary care centres. Till date CIMs have not been evaluated in the Indian context, and the performance of CIMs in improving fungal culture positivity rates is not known, due to low fungal burden in the UK (<1% of the samples evaluated in Liverpool). Hypothesis: CIMs will be non-inferior to conventional microbial keratitis sampling with a sharp instrument (current gold-standard) when evaluated by broth and solid culture.
Aim: To evaluate CIMs in comparison to conventional scrapes for microbiological reporting from infectious keratitis patients (fungal suspicion). The Primary comparison will be to culture. The Secondary output will be to compare to smear microscopy. Objectives: 1. To compare the culture positivity rate between conventional (Scraping) method and CIM 2. To compare the smear positivity rate between conventional (Scraping) method and CIM 3. To evaluate the efficacy of CIMs with respect to fungal keratitis Type of study: Prospective PILOT study for evaluation of an alternative sample collection method for microbial keratitis sampling
|