COVID-19NCT06355128
A Cross-sectional Study of Ocular Manifestations During the Covid-19 Pandemic in Hubei Province
An observational study of COVID-19 and Ocular Surface Disease, run by Zhongnan Hospital at 1 site in China.
Trial summary
To investigate the clinical features of ocular manifestations during the novel coronavirus pneumonia pandemic in Hubei at the end of 2022 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19, Ocular Surface Disease
- What is being tested?
- NOT
- How many people
- 16,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 30 Apr 2024
- How long will I take part?
- 1 Month
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: People from Hubei Province, China
Who may be able to join
- 1. 2022.12.7 to 2023.2.6 People surveyed by wechat Questionnaire Star 2. 2021.12.7 to 2022.1.6 and 2022.11.7 to 2023.1.6 Patients who received ophthalmology treatment in Zhongnan Hospital of Wuhan University and Qichun People's Hospital
Who cannot join
- 1. currently hospitalized patients. 2. severe patients. 3. Incomplete information. 4. cannot be contacted by telephone. 5. Refuse questionnaire survey. 6.The electronic medical record information is incomplete. 7. Those who do not go to the ophthalmic clinic after registration. 8.severe patients. 9. Cannot be contacted by phone.
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the clinical features of ocular manifestations during the novel coronavirus pneumonia pandemic in Hubei at the end of 2022
Read the detailed description
During late 2022 COVID-19 pandemic ocular discomforts were common in people with mild systemic symptoms, but most resolve on their own without any treatment. The disease spectrum of ophthalmology outpatient clinics is affected by the COVID-19 pandemic. In our study, we observed that the incidence of keratitis and acute angle-closure glaucoma in Phase A was significantly higher than that in Phase B and C.
- Conditions
- COVID-19, Ocular Surface Disease
- Being tested
- NOT
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOTOther
NOT
| Study group | Role | What they receive |
|---|---|---|
| the pandemic period (Phase A) | the pandemic period (Phase A) Receives: Other: NOT | |
| the prevention and control periods (Phase B: November 7, 2022 to December 6, 2022 ). | the prevention and control periods (Phase B: November 7, 2022 to December 6, 2022 and Phase C: December 7, 2021 to January 6, 2022). Receives: Other: NOT | |
| the prevention and control periods (Phase C: December 7, 2021 to January 6, 2022). | the prevention and control periods (Phase B: November 7, 2022 to December 6, 2022 and Phase C: December 7, 2021 to January 6, 2022). Receives: Other: NOT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire data were collected and statistically analyzed.
Information on demographic characteristics, COVID-19 pathogen test results, Covid-19 related systemic symptoms, ocular symptoms and eye discomfort medication was collected from questionnaires during the pandemic period (Phase A: December 7, 2022 to January 6, 2023, 1968 patients). Electronic medical records in the ophthalmic outpatient department of Zhongnan Hospital of Wuhan University and its medical union hospital- Qichun County People's Hospital were extracted during the pandemic period (Phase A) and the prevention and control periods (Phase B: November 7, 2022 to December 6, 2022 and Phase C: December 7, 2021 to January 6, 2022). The demographic, epidemiological, and clinical information of patients were compared.
Measured: 1/4/2024-30/4/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 Jan 2024
- Primary completion18 Feb 2024
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- 16,000 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Qichun People's Hospital
- Responsible party
- Principal investigator, Min Ke, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355128
- Sponsor's protocol ID
- 20240307
- Status last verified
- Apr 2024
- First submitted
- 21 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bao Q, Shen Y, Zheng Z, Zheng Y, Li Y, Ren Y, Zhang N, Chen X, Ke M. Changes in the spectrum of ocular disease during the COVID-19 pandemic in late 2022 in the Hubei Province. Sci Rep. 2025 Feb 21;15(1):6297. doi: 10.1038/s41598-025-89791-7.
PubMed 39984575
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study of Ocular Manifestations During the Covid-19 Pandemic in Hubei Province
- ClinicalTrials.gov ID
- NCT06355128
- Acronym / sponsor ID
- 20240307
- Conditions
- COVID-19, Ocular Surface Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16,000 participants (actual)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Collaborators
- Qichun People's Hospital
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 18 Feb 2024 (actual)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 9 Apr 2024 (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 investigate the clinical features of ocular manifestations during the novel coronavirus pneumonia pandemic in Hubei at the end of 2022
Detailed description
During late 2022 COVID-19 pandemic ocular discomforts were common in people with mild systemic symptoms, but most resolve on their own without any treatment. The disease spectrum of ophthalmology outpatient clinics is affected by the COVID-19 pandemic. In our study, we observed that the incidence of keratitis and acute angle-closure glaucoma in Phase A was significantly higher than that in Phase B and C.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the pandemic period (Phase A) | – | Other: NOTthe pandemic period (Phase A) |
| the prevention and control periods (Phase B: November 7, 2022 to December 6, 2022 ). | – | Other: NOTthe prevention and control periods (Phase B: November 7, 2022 to December 6, 2022 and Phase C: December 7, 2021 to January 6, 2022). |
| the prevention and control periods (Phase C: December 7, 2021 to January 6, 2022). | – | Other: NOTthe prevention and control periods (Phase B: November 7, 2022 to December 6, 2022 and Phase C: December 7, 2021 to January 6, 2022). |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- People from Hubei Province, China
Key inclusion criteria (1 listed)
- 1. 2022.12.7 to 2023.2.6 People surveyed by wechat Questionnaire Star 2. 2021.12.7 to 2022.1.6 and 2022.11.7 to 2023.1.6 Patients who received ophthalmology treatment in Zhongnan Hospital of Wuhan University and Qichun People's Hospital
Key exclusion criteria (1 listed)
- 1. currently hospitalized patients. 2. severe patients. 3. Incomplete information. 4. cannot be contacted by telephone. 5. Refuse questionnaire survey. 6.The electronic medical record information is incomplete. 7. Those who do not go to the ophthalmic clinic after registration. 8.severe patients. 9. Cannot be contacted by phone.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOTNOT | Other | the pandemic period (Phase A), the prevention and control periods (Phase B: November 7, 2022 to December 6, 2022 )., the prevention and control periods (Phase C: December 7, 2021 to January 6, 2022). |
Primary outcome
Questionnaire data were collected and statistically analyzed.
Time frame: 1/4/2024-30/4/2024
Information on demographic characteristics, COVID-19 pathogen test results, Covid-19 related systemic symptoms, ocular symptoms and eye discomfort medication was collected from questionnaires during the pandemic period (Phase A: December 7, 2022 to January 6, 2023, 1968 patients). Electronic medical records in the ophthalmic outpatient department of Zhongnan Hospital of Wuhan University and its medical union hospital- Qichun County People's Hospital were extracted during the pandemic period (Phase A) and the prevention and control periods (Phase B: November 7, 2022 to December 6, 2022 and Phase C: December 7, 2021 to January 6, 2022). The demographic, epidemiological, and clinical information of patients were compared.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Derived from this study: PubMed 39984575Bao Q, Shen Y, Zheng Z, Zheng Y, Li Y, Ren Y, Zhang N, Chen X, Ke M. Changes in the spectrum of ocular disease during the COVID-19 pandemic in late 2022 in the Hubei Province. Sci Rep. 2025 Feb 21;15(1):6297. doi: 10.1038/s41598-025-89791-7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COVID-19 and Ocular Surface Disease, run by Zhongnan 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Apr 2024. 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?
Results are not available in the source record.
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?
Questionnaire data were collected and statistically analyzed. (time frame: 1/4/2024-30/4/2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06355128, which also lists 1 linked publication.
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 9 Apr 2024.