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NCT05372861 Clinical Trial

Nanopore Sequencing in Ophthalmology

Endophthalmitis Clinical Trial

Official title:
Nanopore Sequencing in Ophthalmology - a Paradigm Shift in Pathogen Determination?

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05372861
Other study ID # NSIO
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 22, 2022
Est. completion date December 1, 2024

Study information
Verified date December 2023
Source Medical University of Graz
Contact Michael Sommer, MD
Phone 004331638531033
Email michael.sommer@medunigraz.at
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this pilot study, the feasibility of the Oxford Nanopore MinION to identify pathogens from vitrectomy samples in eyes with endophthalmitis shall be assessed. The MinION is a low cost commercially available device for DNA/ RNA analysis that, in studies, has been used for pathogen determination in various infectious diseases as well as for the genetic characterization of hematologic tumors.

Description:

Vitreous samples and anterior chamber taps from eyes with endophthalmitis are taken during routine vitrectomy. The gathered samples are divided in half to undergo routine culture for microbial growth and nanopore sequencing with the MinION Mk1b, a commercially available device for DNA/RNA sequencing. Base reads from Nanopore sequencing are then compared with available libraries for pathogen identification. The Nanopore sequencing results for pathogens are compared versus the results of the microbiological culture of the same eye as the gold standard. Clinical features and visual function before and after vitrectomy are gathered from patient charts. Treatment is not altered due to results of the Nanopore sequencing.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 1, 2024
Est. primary completion date December 1, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Eyes of patients with endophthalmitis Exclusion Criteria: - No informed consent possible - Participation in other studies

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Austria Universitäts Augenklinik Graz Graz Styria

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pathogen detection Pathogens detected by Nanopore sequencing versus microbiologic culture In vitro analysis after vitrectomy for endophthalmitis. Start of analysis: Within the next working day after sample acquisition. Time for Nanopore sequencing: Approximately up to 10 hours. Time for culture: 24 hours up to 14 days.
Secondary Time to pathogen detection Time in days from gathering of the sample until arrival of results Time measured from start of analysis until arrival of results. Time for Nanopore sequencing: Approximately up to 10 hours. Time for culture: 24 hours up to 14 days.
Secondary Visual acuity Visual acuity measured with Snellen charts Gathered from patient charts two months after vitrectomy.
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