Corneal Wavefront AberrationNCT05882383
Changes of Optical Quality During the Peak of the Covid-19 Pandemic
An observational study of Corneal Wavefront Aberration and SARS-CoV-2, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
To explore whether cornea structure, and optical quality are affected by the covid-19 infection. Read more about this study
- Who is it for?
- Ages 18 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Wavefront Aberration, SARS-CoV-2
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2022to 20 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 32 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: patients admitted to refractive center of Tianjin Eye Hospital
Who may be able to join
None listed.
Who cannot join
- corneal disease;
- ocular trauma;
- Pregnant and lactating women;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Corneal Wavefront Aberration, SARS-CoV-2
- Keywords
- optical quality
- Medical subject headings
- Corneal Wavefront Aberration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
The value of cornea aberration
The value of aberration data from pentacam during follow-up were compared, including coma, spherical aberration, defocus, and astigmatism
Measured: 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
Measured: 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.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start25 Nov 2022
- Primary completion20 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Wavefront AberrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Wang, Prof, Study chair, Tianjin eye hosipital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882383
- Sponsor's protocol ID
- KY-2023019
- Status last verified
- May 2023
- First submitted
- 8 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Optical Quality During the Peak of the Covid-19 Pandemic From November 2022 to January 2023 in China
- ClinicalTrials.gov ID
- NCT05882383
- Acronym / sponsor ID
- KY-2023019
- Conditions
- Corneal Wavefront Aberration, SARS-CoV-2
- Keywords
- optical quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore whether cornea structure, and optical quality are affected by the covid-19 infection.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- patients admitted to refractive center of Tianjin Eye Hospital
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- corneal disease;
- ocular trauma;
- Pregnant and lactating women;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The value of cornea aberration
Time frame: 1 months
The value of aberration data from pentacam during follow-up were compared, including coma, spherical aberration, defocus, and astigmatism
The value of cornea backscatter
Time frame: 1 months
The value of cornea backscatter from pentacam during follow-up were compared, including anterior layer，central layer and posterior
The value of cornea thickness
Time frame: 1 months
The value of cornea thickness from pentacam during follow-up were compared, includig the thinnest point, apex of the cornea.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Corneal Wavefront Aberration
Not yet recruiting
Factors Influencing Subjective Visual Quality in Human Eyes
Corneal Wavefront Aberration, Refractive Errors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Wang, Prof study chair
Tianjin eye hosipital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Wavefront Aberration and SARS-CoV-2, run by Tianjin Eye Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The value of cornea aberration (time frame: 1 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.