- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04907981
Eye Detection to Identify Novel Coronavirus Infection
June 11, 2021 updated by: Wuhan Union Hospital, China
Risk Screening Based on Feature Recognition and Detection of Eye Surface Images of COVID-2019 Patients and Statistical Analysis of High-dimensional Data
The eye characteristics of patients with COVID-19 and those without the disease were analyzed, and whether they had the disease or not was judged according to the eye characteristics.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To test the accuracy of a non-invasive eye monitoring that can be widely used for screening in judging patients with novel coronavirus infection.
Study Type
Observational
Enrollment (Actual)
232
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hebei
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Shijiazhuang, Hebei, China, 050024
- Shijiazhuang Fifth Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Hospital
Description
Inclusion Criteria:
- All participants were provided with written informed consent at the time of recruitment;
- Age ≥ 18 and ≤ 75 (informed consent signed by guardian under 18)
- Meet the diagnostic criteria of novel coronavirus (2019-COVID-19) infection
Exclusion Criteria:
Does not meet any of the inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Novel coronavirus infection
All patients were diagnosed according to the diagnostic criteria of the National Health Commission of China and confirmed by RT-PCR detection of viral nucleic acids.
|
Using eye examination to judge whether novel coronavirus is infected or not.
|
|
Not infected by novel coronavirus
Healthy controls and patients with liver disease
|
|
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Recovered patients with nucleic acid negative after infection with novel coronavirus
Novel coronavirus nucleic acid changed from positive to negative.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Collection and analysis of eye characteristics of patients encoding criteria, annotation of ocular feature
Time Frame: 1DAY
|
Ocular pathological features
|
1DAY
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lei zhao, Wuhan Union Hospital, China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 22, 2021
Primary Completion (Actual)
April 26, 2021
Study Completion (Actual)
April 26, 2021
Study Registration Dates
First Submitted
May 23, 2021
First Submitted That Met QC Criteria
May 27, 2021
First Posted (Actual)
June 1, 2021
Study Record Updates
Last Update Posted (Actual)
June 14, 2021
Last Update Submitted That Met QC Criteria
June 11, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- COVID-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.