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| Name | Class |
|---|---|
| Shanghai Fourth People's Hospital Tongji University | OTHER |
| The Central Hospital of Huanggang | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eye infections cohort | Patients diagnosed with on one or more type of eye infections (including acute conjunctivitis, keratitis, uveitis, and endophthalmitis). |
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| Measure | Description | Time Frame |
|---|---|---|
| The pathogen profile | The bacteria, fungi, viruses, and parasites identified through metagenomic techniques in ocular samples. | through study completion, an average of 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Microbial abundance | 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 |
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Inclusion Criteria:
Exclusion Criteria:
1. Patients who have no historically clinical surplus specimens.
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Patients diagnosed with one or more types of eye infections (including acute conjunctivitis, keratitis, uveitis, and endophthalmitis).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mei Kang, MPH | Contact | 021-36126064 | mei.kang@shgh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shuo Su, PhD | Fudan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36757718 | Background | Vasquez-Perez A, Magan T, Volpe G, Osborne SF, McFaul K, Vahdani K. Necrotizing Blepharoconjunctivitis and Keratitis in Human Monkeypox. JAMA Ophthalmol. 2023 Mar 1;141(3):285-288. doi: 10.1001/jamaophthalmol.2022.6253. | |
| 36069833 | Background | Rose-Nussbaumer J, Doan T. Role of Ophthalmology in Emerging Infectious Diseases. JAMA Ophthalmol. 2022 Oct 1;140(10):935. doi: 10.1001/jamaophthalmol.2022.4017. |
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IPD could be available on request to the principle investigators.
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| ID | Term |
|---|---|
| D015817 | Eye Infections |
| D004194 | Disease |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005128 | Eye Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Conjunctival sac swabs (1 swab for each involving eye), intraocular fluid (more than 100μl).
| 39571607 | Background | Barshak MB, Durand ML, Gupta A, Mohareb AM, Dohlman TH, Papaliodis GN. State-of-the-Art Review: Ocular Infections. Clin Infect Dis. 2024 Nov 22;79(5):e48-e64. doi: 10.1093/cid/ciae433. |
| 38118024 | Background | Durand ML, Barshak MB, Sobrin L. Eye Infections. N Engl J Med. 2023 Dec 21;389(25):2363-2375. doi: 10.1056/NEJMra2216081. No abstract available. |
| 26107917 | Background | Ranjan R, Ranjan S. Ocular Pathology: Role of Emerging Viruses in the Asia-Pacific Region-A Review. Asia Pac J Ophthalmol (Phila). 2014 Sep-Oct;3(5):299-307. doi: 10.1097/APO.0000000000000021. |
| 37917077 | Background | Tsui E, Sella R, Tham V, Kong AW, McClean E, Goren L, Bahar I, Cherian N, Ramirez J, Hughes RE Jr, Privratsky JK, Onclinx T, Feit-Leichman R, Cheng A, Molina I, Kim P, Yu C, Ruder K, Tan A, Chen C, Liu Y, Abraham T, Hinterwirth A, Zhong L, Porco TC, Lietman TM, Seitzman GD, Doan T; SCORPIO Study Group. Pathogen Surveillance for Acute Infectious Conjunctivitis. JAMA Ophthalmol. 2023 Dec 1;141(12):1140-1144. doi: 10.1001/jamaophthalmol.2023.4785. |
| 28942073 | Background | Austin A, Lietman T, Rose-Nussbaumer J. Update on the Management of Infectious Keratitis. Ophthalmology. 2017 Nov;124(11):1678-1689. doi: 10.1016/j.ophtha.2017.05.012. Epub 2017 Sep 21. |
| 29774834 | Background | Ai JW, Weng SS, Cheng Q, Cui P, Li YJ, Wu HL, Zhu YM, Xu B, Zhang WH. Human Endophthalmitis Caused By Pseudorabies Virus Infection, China, 2017. Emerg Infect Dis. 2018 Jun;24(6):1087-1090. doi: 10.3201/eid2406.171612. |
| 32015508 | Background | Wu F, Zhao S, Yu B, Chen YM, Wang W, Song ZG, Hu Y, Tao ZW, Tian JH, Pei YY, Yuan ML, Zhang YL, Dai FH, Liu Y, Wang QM, Zheng JJ, Xu L, Holmes EC, Zhang YZ. A new coronavirus associated with human respiratory disease in China. Nature. 2020 Mar;579(7798):265-269. doi: 10.1038/s41586-020-2008-3. Epub 2020 Feb 3. |
| 30918369 | Background | Chiu CY, Miller SA. Clinical metagenomics. Nat Rev Genet. 2019 Jun;20(6):341-355. doi: 10.1038/s41576-019-0113-7. |
| 33607016 | Background | Burton MJ, Ramke J, Marques AP, Bourne RRA, Congdon N, Jones I, Ah Tong BAM, Arunga S, Bachani D, Bascaran C, Bastawrous A, Blanchet K, Braithwaite T, Buchan JC, Cairns J, Cama A, Chagunda M, Chuluunkhuu C, Cooper A, Crofts-Lawrence J, Dean WH, Denniston AK, Ehrlich JR, Emerson PM, Evans JR, Frick KD, Friedman DS, Furtado JM, Gichangi MM, Gichuhi S, Gilbert SS, Gurung R, Habtamu E, Holland P, Jonas JB, Keane PA, Keay L, Khanna RC, Khaw PT, Kuper H, Kyari F, Lansingh VC, Mactaggart I, Mafwiri MM, Mathenge W, McCormick I, Morjaria P, Mowatt L, Muirhead D, Murthy GVS, Mwangi N, Patel DB, Peto T, Qureshi BM, Salomao SR, Sarah V, Shilio BR, Solomon AW, Swenor BK, Taylor HR, Wang N, Webson A, West SK, Wong TY, Wormald R, Yasmin S, Yusufu M, Silva JC, Resnikoff S, Ravilla T, Gilbert CE, Foster A, Faal HB. The Lancet Global Health Commission on Global Eye Health: vision beyond 2020. Lancet Glob Health. 2021 Apr;9(4):e489-e551. doi: 10.1016/S2214-109X(20)30488-5. Epub 2021 Feb 16. No abstract available. |