Ocular Findings and Viral Persistence in Ocular Fluids in COVID-19 Survivors
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|ClinicalTrials.gov Identifier: NCT04665752|
Recruitment Status : Recruiting
First Posted : December 14, 2020
Last Update Posted : December 16, 2021
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.
To examine possible changes in the eye that might have occurred as a result of COVID-19.
Adults age 18 and older who were diagnosed with COVID-19 and recovered.
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.
|Condition or disease|
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.
Primary Objective: To investigate if COVID survivors show signs of anterior or posterior segment inflammation or other retinochoroidal changes after recovery.
To investigate if SARS-Cov-2 can be detected in the ocular fluids or tissues of survivors among patients who undergo medically indicated ocular surgery or diagnostic procedures.
Exploratory Objective: To investigate whether the use of chloroquine/Hydroxychloroquine for treatment of COVID-19 is associated with ocular changes.
Primary Endpoint: Percentage of patients with Ocular exam abnormalities such as conjunctival/corneal, anterior segment, choroidal, retinal lesions and subclinical findings on OCT, FA and ICG
Correlation of ocular findings with COVID severity (by history)
Proportion of patients with +SARS-COV-2 PCR in ocular fluid/tissues among COVID-19 survivors and correlation to clinical characteristics and IgG levels
Up to 150 COVID-19 survivors will be recruited.
Description of Sites/Facilities Enrolling Participants:
This protocol will enroll participants at the NIH CC. De-identified samples may be received from the New York Medical Center.
The participants will be asked to come to the NIH CC for one visit. A select subgroup of up to 75 participants with positive findings may be asked to return within 12 months from their initial visit.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Ocular Findings and Viral Persistence in Ocular Fluids in COVID-19 Survivors, a Natural History, Observational Study|
|Actual Study Start Date :||February 2, 2021|
|Estimated Primary Completion Date :||June 30, 2023|
|Estimated Study Completion Date :||June 30, 2023|
Participants previously diagnosed with COVID-19.
- Percentage of participants [ Time Frame: 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.
- Correlation of findings [ Time Frame: Over the study duration ]Correlation of ocular findings with COVID severity
- Proportion of patients [ Time Frame: Over the study duration ]Proportion of patients with +SARS-COV-2 PCR in ocular fluid/tissues among COVID-19 survivors and correlation to clinical characteristics and IgG levels.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04665752
|Contact: Dominic Obiyor, R.N.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Shilpa M Kodati, M.D.||National Eye Institute (NEI)|