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A special membrane used to collect samples from the eye surface to test for corneal ulcers

Corneal Impression Membrane (CIM) Sampling for Microbial Keratitis Diagnosis - CIMS

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/086646
Enrollment
70
Registered
2025-05-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H160- Corneal ulcer

Interventions

Intervention1: Using corneal impression membrane for obtaining material for diagnostic investigations: Under topical anaesthesia, corneal impression membrane will be used to obtain samples for - a)Sme

Sponsors

Aravind Eye Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Suspicion of Fungal Keratitis and Undergoing routine corneal scraping for diagnostic purposes

Exclusion criteria

Exclusion criteria: Suspected Viral, Acanthamoeba, Mixed Keratitis cases Microbial Keratitis in both eyes Perforated ulcer Small ulcer of less than 3 mm

Design outcomes

Primary

MeasureTime frame
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. Timepoint: The microbiology positivity will be checked at Day 1, 3 days, 1 week and 2 weeks.

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactJosephine Christy

Aravind Eye Hospital

josephine@aravind.org9994549584

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026