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NCT Number: NCT06775808

Total Infectome Characterization of Eye Infections

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200030, China

Location status: Recruiting

Location contact

Mei Kang, MPH

CONTACT

[email protected]

02136126064

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients who have no historically clinical surplus specimens.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Mei Kang, MPH

CONTACT

[email protected]

021-36126064

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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