An observational study in COVID-19, sponsored by National Eye Institute (NEI). Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-06.
Sponsored by National Eye Institute (NEI) · Observational
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.
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:
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.
Endpoints:
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
Secondary Endpoints:
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
Study Population:
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.
Study Duration:
2 years
Participant Duration:
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.
7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 8 is below the median of 260 across 3,135 observational studies indexed under COVID-19.
Browse COVID-19 studies →National Eye Institute (NEI) is the lead sponsor of 266 studies on the registry; 17 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants diagnosed with COVID-19 and at least 30 days symptom-free.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
Participants previously diagnosed with COVID-19.
Percentage of participants
Percentage of participants with ocular exam abnormalities, such as conjunctival/corneal anterior segment, choroidal, retinal lesions and subclinical findings on OCT, FA, and ICG.
Time frame: Over the study duration
Correlation of findings
Correlation of ocular findings with COVID severity
Time frame: Over the study duration
Proportion of patients
Proportion of patients with +SARS-COV-2 PCR in ocular fluid/tissues among COVID-19 survivors and correlation to clinical characteristics and IgG levels.
Time frame: Over the study duration
This study is terminated, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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National Eye Institute (NEI)