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临床试验/NCT04945850
NCT04945850已完成不适用

Can COVID-19 Persist in Intraocular Fluid?

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年6月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Analyzing COVID-19

研究概览

简要总结

Several common viruses thrive and persist in intraocular fluid due to ocular immune privilege. Immune privilege is maintained by lack of lymphatic tissue, a strong blood ocular barrier, and regulation of the systemic immune response via immunosuppressive factors such as TGF-B and processes like anterior chamber associated immune deviation. Notable viruses that benefit from ocular immune sequestration include DNA viruses such as Herpes simplex virus, Varicella Zoster, Cytomegalovirus and RNA viruses like Ebola and Rubella.In light of the global 2019 Severe acute respiratory syndrome coronavirus-2 virus (SARS CoV-2 or commonly COVID-19) pandemic, there has been growing interest on COVID-19's long term effects on the ocular system. Ocular symptoms at the time of diagnosis and during illness have been reported previously. The most commonly reported are epiphora, chemosis, and conjunctivitis. Less common were findings of retinal hemorrhages and retinal ischemic changes. Recent literature has demonstrated its presence in ocular fluid such as tears and the aqueous humor, but whether this is sustained for an extended period of time has yet to be determined. Long term effects of covid on the neurological system are being identified - large vessel ischemic strokes, cerebral hemorrhages, cranial nerve palsies, and memory loss in young adults are being reported. The persistence of COVID 19 in the intraocular fluid several months after covid infection has not been studied previously.

详细描述

Animal Studies and Previous Human Studies

Other coronavirus murine and feline models have shown ocular involvement. In Robbins et al experiment, mice underwent intracameral and intravitreal injections with murine coronavirus. Within 3 days, those with injections into the AC demonstrated a variety of findings such as keratitis and anterior uveitis; whereas those who underwent intravitreal injection had multilayered retinal lesions with RPE scarring and retinal atrophy. CNS disease and/or death occurred in a third of those from intravitreal injections. Viral antigens have been isolated from these mice but there is evidence immune cells and pro-inflammatory factors also contribute to the retinopathy findings. This murine model, known as Experimental CoV Retinopathy, has been used to examine host immune response that lead to retinal damage. Cats infected with feline infectious peritonitis virus, a feline coronavirus, manifested with conjunctivitis, pyogranulomatous anterior uveitis, retinal vasculitis, choroiditis and retinal detachment. Over 90% of the cats had antigen detected in the conjunctiva.

Viruses such as VZV, HSV, and CMV and parasites like Toxoplasmosis have been isolated from the intraocular fluid of human eyes using polymerase chain reaction (PCR), despite having normal or negative serum titers.

Enrollment/Randomization

Those who meet inclusion criteria will be provided an opportunity to participate in study. They will provide written informed consent in accordance with the HIPAA regulations and Vanderbilt IRB approval.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • Proof of previous COVID-19 infection
  • Patients scheduled for elective ocular surgery at Vanderbilt Medical Center

排除标准

  • 17 years of age and younger

结局指标

主要结局

Analyzing COVID-19

时间窗: 12 months

Analyzing COVID-19 using ocular fluids.

Duration of persistent virus isolation

时间窗: 12 months

Duration of persistent virus isolation from intraocular fluid

Presence of Covid-19

时间窗: 12 months

We aim to examine the presence of COVID-19 in the intraocular fluid.

Microbiological methods

时间窗: 12 months

microbiological methods of diagnosing.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sapna Gangaputra

Principal Investigator

Vanderbilt University Medical Center

研究点 (1)

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