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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05882383
Other study ID # KY-2023019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 25, 2022
Est. completion date January 20, 2023

Study information

Verified date May 2023
Source Tianjin Eye Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To explore whether cornea structure, and optical quality are affected by the covid-19 infection.


Description:

Participants with healthy corneas admitted to Tianjin Eye Hospital from November 25 to January 20, 2022 were followed up . At the end of the follow-up, the investigators recorded in detail whether the patients had undergone real-time reverse transcriptase polymerase chain reaction (covid-19 RT-PCR tests) testing, testing time and results. The presence of PCR-positive during follow-up is considered to be covid-19 infection; PCR-Negative and no symptoms of infection during the follow-up period are considered not infected; participants with symptoms but no PCR test were excluded from the study.Participants were divided into three groups according to the RT-PCR results and the presence or absence of symptoms of infection during follow-up. pentacam (Pentacam HR, Oculus, Wetzlar, Germany) was performed during follow-up and the results were recorded,and the data was statistically managed and compared.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date January 20, 2023
Est. primary completion date January 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 32 Years
Eligibility Included Criteria 1. Best corrected visual acuity (BCVA) = 20/20; 2. No other eye diseases except myopia and astigmatism; 3. The cornea was transparent, and there was no cloud or pannus; 4. No clinical manifestation of Eye disease or systemic disease; Exclusion Criteria: 1. corneal disease; 2. ocular trauma; 3. Pregnant and lactating women;

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Tianjin Eye Hospital Tianjin Tianjin

Sponsors (1)

Lead Sponsor Collaborator
Tianjin Eye Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The value of cornea aberration The value of aberration data from pentacam during follow-up were compared, including coma, spherical aberration, defocus, and astigmatism 1 months
Primary The value of cornea backscatter The value of cornea backscatter from pentacam during follow-up were compared, including anterior layer,central layer and posterior 1 months
Primary The value of cornea thickness The value of cornea thickness from pentacam during follow-up were compared, includig the thinnest point, apex of the cornea. 1 months
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