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Nanopore Sequencing in Ophthalmology

Sponsor
Medical University of Graz (Other)
Overall Status
Recruiting
CT.gov ID
NCT05372861
Collaborator
(none)
20
Enrollment
1
Location
31.3
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Nanopore Sequencing in Ophthalmology - a Paradigm Shift in Pathogen Determination?
    Actual Study Start Date :
    Apr 22, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Pathogen detection [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.]

      Pathogens detected by Nanopore sequencing versus microbiologic culture

    Secondary Outcome Measures

    1. Time to pathogen detection [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.]

      Time in days from gathering of the sample until arrival of results

    2. Visual acuity [Gathered from patient charts two months after vitrectomy.]

      Visual acuity measured with Snellen charts

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Eyes of patients with endophthalmitis
    Exclusion Criteria:

    • No informed consent possible

    • Participation in other studies

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universitäts Augenklinik Graz Graz Styria Austria 8036

    Sponsors and Collaborators

    • Medical University of Graz

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medical University of Graz
    ClinicalTrials.gov Identifier:
    NCT05372861
    Other Study ID Numbers:
    • NSIO
    First Posted:
    May 13, 2022
    Last Update Posted:
    May 13, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Medical University of Graz
    Endophthalmitis
    Nanopore sequencing
    Next Generation Sequencing
    Additional relevant MeSH terms:
    Endophthalmitis

    Study Results

    No Results Posted as of May 13, 2022