NCT05372861

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
19mo left

Started Apr 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Apr 2022Dec 2027

First Submitted

Initial submission to the registry

April 22, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

April 22, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 13, 2022

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

4.6 years

First QC Date

April 22, 2022

Last Update Submit

September 29, 2025

Conditions

Endophthalmitis

Keywords

EndophthalmitisNanopore sequencingNext Generation Sequencing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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.

  • Visual acuity

    Gathered from patient charts two months after vitrectomy.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eyes of adult patients with endophthalmitis

You may qualify if:

  • Eyes of patients with endophthalmitis

You may not qualify if:

  • No informed consent possible
  • Participation in other studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitäts Augenklinik Graz

Graz, Styria, 8036, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Vitreous and aqueous humor samples in eyes with endophthalmitis gathered during vitrectomy.

MeSH Terms

Conditions

Endophthalmitis

Condition Hierarchy (Ancestors)

Eye InfectionsInfectionsEye Diseases

Central Study Contacts

Michael Sommer, MD

CONTACT

004331638531033michael.sommer@medunigraz.at

Gerald Seidel, MD, PhD

CONTACT

004331638580714gerald.seidel@medunigraz.at

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2022

First Posted

May 13, 2022

Study Start

April 22, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

September 30, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)