Clincosm LogoSign in Get a demo

Changes of Optical Quality During the Peak of the Covid-19 Pandemic

Sponsor
Tianjin Eye Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05882383
Collaborator
(none)
110
Enrollment
1
Location
1.8
Actual Duration (Months)
59.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    110 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Changes of Optical Quality During the Peak of the Covid-19 Pandemic From November 2022 to January 2023 in China
    Actual Study Start Date :
    Nov 25, 2022
    Actual Primary Completion Date :
    Jan 20, 2023
    Actual Study Completion Date :
    Jan 20, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Control Group

    unifected with SARS-CoV-2 during follow-up
    Group A

    uninfected at the first visit, have been infected at the second visit
    group B

    have been infected at twice visit

    Outcome Measures

    Primary Outcome Measures

    1. The value of cornea aberration [1 months]

      The value of aberration data from pentacam during follow-up were compared, including coma, spherical aberration, defocus, and astigmatism

    2. The value of cornea backscatter [1 months]

      The value of cornea backscatter from pentacam during follow-up were compared, including anterior layer，central layer and posterior

    3. The value of cornea thickness [1 months]

      The value of cornea thickness from pentacam during follow-up were compared, includig the thinnest point, apex of the cornea.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 32 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tianjin Eye Hospital Tianjin Tianjin China

    Sponsors and Collaborators

    • Tianjin Eye Hospital

    Investigators

    • Study Chair: Yan Wang, Prof, Tianjin eye hosipital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tianjin Eye Hospital
    ClinicalTrials.gov Identifier:
    NCT05882383
    Other Study ID Numbers:
    • KY-2023019
    First Posted:
    May 31, 2023
    Last Update Posted:
    May 31, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tianjin Eye Hospital
    optical quality
    Additional relevant MeSH terms:
    COVID-19
    Corneal Wavefront Aberration

    Study Results

    No Results Posted as of May 31, 2023