Total Infectome Characterization of Eye Infections

July 14, 2025 updated by: Biao Yan, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Total Infectome Characterization of Eye Infections: a Metagenomic Sequencing Based Observational Study

Multiple pathogens can cause eye infection. In recent years, emerging and resurging viral infections represent an important public health problem. Many emerging viruses cause infectious diseases involving ophthalmic manifestations, including Mpox virus, Zika, Ebola, and SARS-CoV-2. Broad and unbiased pathogen surveillance is essential, so we design this unbiased metagenomic sequencing based study to investigate the total infectome of eye infections. The study is historical and prospective in design.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This is an investigator-initiated observational study to describe the total infectome of eye infections using metagenomic sequencing. The eye infections, including acute conjunctivitis, keratitis, uveitis, and endophthalmitis, are diagnosed by experienced ophthalmologists according to routine clinical exams.

For the collection of additional biological samples apart from the diagnosis and treatment process, written informed consent is required from the eligible subjects or their legal guardians at the recruitment time is required. The application for exemption of informed consent has been made for using clinical surplus samples. After completing informed consent, subjects will be sampled, and their clinical information will be collected.

Biospecimens, including conjunctival sac swabs (1 swab for each involving eye), or intraocular fluid (more than 100μl), will be collected for metagenomic sequencing using the Illumina NovaSeq X Plus platform.

The clinical information of participants will be collated from electronic medical record information system, including (1) demographic characteristics: age, sex, comorbidities; (2) laboratory examination: blood routine test, immune inflammatory factors, clinical microbiology examination (PCR, serological examination, culture, etc.); (3) imaging examination: anterior segment photograph, corneal endothelial cell examination, corneal confocal microscopy, fundus photograph.

Meta-transcriptomic analysis of the ocular samples will be conducted to identify viruses, bacteria, fungi and parasites. The abundance of pathogens is indicated as the RPKM (i.e. Reads Per Million divided by the length of the reference genome, measured in kilobases).

Eligible participants will be recruited consecutively between August, 2024 and December, 2026 in Department of Ophthalmology, Shanghai General Hospital. The total study duration is expected to be two years from the first subject enrolled to the final analysis.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with one or more types of eye infections (including acute conjunctivitis, keratitis, uveitis, and endophthalmitis).

Description

Inclusion Criteria:

  1. Patients with a clinical diagnosis of one or more types of eye infections (including acute conjunctivitis, keratitis, uveitis, and endophthalmitis).
  2. Biological samples has been collected for clinical microbiological examination, or consented to participate in this study.

Exclusion Criteria:

1. Patients who have no historically clinical surplus specimens.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Eye infections cohort
Patients diagnosed with on one or more type of eye infections (including acute conjunctivitis, keratitis, uveitis, and endophthalmitis).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The pathogen profile
Time Frame: through study completion, an average of 2 year
The bacteria, fungi, viruses, and parasites identified through metagenomic techniques in ocular samples.
through study completion, an average of 2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbial abundance
Time Frame: through study completion, an average of 2 year
The pathogen abundance is measure by the RPKM (i.e. Reads Per Million divided by the length of the reference genome, measured in kilobases).
through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

The Central Hospital of Huanggang
Shanghai Fourth People's Hospital Tongji University

Investigators

  • Study Director: Shuo Su, PhD, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 25, 2024

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 6, 2025

First Submitted That Met QC Criteria

January 9, 2025

First Posted (Actual)

January 15, 2025

Study Record Updates

Last Update Posted (Actual)

July 17, 2025

Last Update Submitted That Met QC Criteria

July 14, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHGH-CRU-2024516

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD could be available on request to the principle investigators.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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