跳至主要内容
临床试验/NCT04665752
NCT04665752终止不适用

Ocular Findings and Viral Persistence in Ocular Fluids in COVID-19 Survivors, a Natural History, Observational Study

National Eye Institute (NEI)1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2021年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
8
试验地点
1
主要终点
Percentage of participants

研究概览

简要总结

Background:

Some people who have had COVID-19 experience changes in the eye. Sometimes these changes are subtle and may not affect vision. Researchers want to learn how many people experience these eye changes and where in the eye they occur to better understand the outcomes of COVID-19 and its treatments.

Objective:

To examine possible changes in the eye that might have occurred as a result of COVID-19.

Eligibility:

Adults age 18 and older who were diagnosed with COVID-19 and recovered.

Design:

Participants will be screened with a medical history and physical exam. They will have blood tests.

Participants will have an eye exam. Their pupils will be dilated with eye drops. Eye pressure and movements will be measured.

Participants will have optical coherence tomography. Pictures will be taken of the retina and the inside of the eyes.

Participants may have fluorescein angiography and indocyanine green angiography. They will be given a dye through an intravenous line. The dye will travel up to the blood vessels in their eyes. Pictures will be taken of the dye as it flows through the blood vessels.

Participants may have electroretinography to test the retina. They will sit in the dark with their eyes patched for 30 minutes. Then they will watch flashing lights while wearing contact lenses that sense signals from the retina.

Participants may have adaptive optics-assisted imaging. They will look at a specific location while images are taken of the retina.

During the study, participants will have blood drawn through a needle in their arm. Fluid or tissue from the eye may be obtained if participants have a medically needed procedure.

Participation will last for 12 months.

详细描述

Study Description:

The objective of this study is to understand the rate and extent of ocular involvement in COVID-19 patients and whether SARS-COV-2 can be detected in ocular fluids or tissue in convalescent phase.

Objectives:

Primary Objective: To investigate if COVID survivors show signs of anterior or posterior segment inflammation or other retinochoroidal changes after recovery.

Secondary Objectives:

研究设计

研究类型
Observational
观察模型
Cohort
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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Percentage of participants

时间窗: Over the study duration

Percentage of participants with ocular exam abnormalities, such as conjunctival/corneal anterior segment, choroidal, retinal lesions and subclinical findings on OCT, FA, and ICG.

次要结局

  • Correlation of findings(Over the study duration)
  • Proportion of patients(Over the study duration)

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验