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

Changes of Optical Quality During the Peak of the Covid-19 Pandemic From November 2022 to January 2023 in China

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

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2; Corneal Wavefront Aberration

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 Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China
      • TianJin eye hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

patients admitted to refractive center of Tianjin Eye Hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Tianjin Eye Hospital
• Investigators: Study Chair: Yan Wang, Prof, Tianjin eye hosipital

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2022
• Primary Completion (Actual): January 20, 2023
• Study Completion (Actual): January 20, 2023

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: May 27, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 27, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: optical quality
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Eye Diseases; Corneal Diseases; Refractive Errors; COVID-19; Corneal Wavefront Aberration
• Other Study ID Numbers: KY-2023019

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