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
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Endophthalmitis

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.