Multiplex Strip Polymerase Chain Reaction for Diagnosis of Eye Infection Diseases From Corneal Scraping Samples

• Conditions: Corneal Ulcer; Eye Infections; Endophthalmitis; Keratitis

• Registration Number: NCT04075669
• Lead Sponsor: Fakultas Kedokteran Universitas Indonesia

Brief Summary

The aim of this study is to see if multiplex strip PCR will detect the pathogen that causing eye infection from the corneal scraping samples with higher sensitivity and specificity than the current gold standard.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2019-08-29
• Study First Submitted QC: 2019-08-29
• Status Verified: 2019-09
• Study First Posted: 2019-09-03
• Last Update Submitted: 2019-09-11
• Last Update Posted: 2019-09-13
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Registered as new patients since July 2019 in RSCM Kirana
• Age more than 18 years
• Have an eye infection (keratitis, endophthalmitis and corneal ulcer) which required corneal scrapping sampling for further diagnosis

Exclusion Criteria

• Not willing to become the participants by not filling the informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Higher sensitivity and specificity by multiplex strip PCR than current gold standard	4 months	Ferrer and Alio (2011) report from 10 years of study shown that culture test as current gold standard will provide positive value by 59.3% for detecting keratitis pathogen. Based on this report, we see the potential increase of positive value by using multiplex PCR around 20 points (70%). Sensitivity will be calculated by true positive divided by all positive patients and specificity will be calculated by true negative divided by all negative patients. The results will be compared with the current gold standard with target increase 20 points or 70%.

Trial Locations

Locations (1)

RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital); 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia