- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05065788
Ophthalmological Emergencies and COVID-19 Pandemia
Impact of COVID-19 Pandemic and Related Lockdown on Eye Emergencies Accesses
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Since the end of 2019, an outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), originating in the Chinese city of Wuhan has spread rapidly worldwide causing thousands of deaths. Coronavirus disease (COVID-19) is supported by SARS-CoV-2 and represents the causative agent of a potentially fatal disease that is of great global public health concern. Italy has been the first European country recording an elevated number of infected forcing the Italian Government to call for total lockdown. The lockdown had the aim to limit the spread of infection through social distancing. The purpose of this study is to analyze how the pandemic has affected the patient's accesses to the Ophthalmological Emergency Department of a tertiary referral center in northern Italy, during the lockdown period. The charts of all patients that came to the Emergency Department during the lockdown period (February -May, 2020 and October - December 2020) will be retrospectively collected and compared with those in the same periods of 2019 .
All demographics and clinical data will be analyzed and compared to evaluate differences and type of accesses.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Varese, Italy, 21100
- ASST Sette Laghi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients registered for access to emergency ophthalmological room in the periods:
2020 from February to May and from October to December 2019 from February to May and from October to December
Description
Inclusion Criteria:
Access to emergency room in the definite periods Completed Patients Charts -
Exclusion Criteria:
Access to emergency room in other periods Demographics and clinical data not completed
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
2020 Lockdown period
Patients who access to Ophthalmological emergency service during lockdown period in 2020
|
data collection
|
|
2019
Patients who access to Ophthalmological emergency service in 2019 definite periods
|
data collection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
number of patients
Time Frame: 1 year
|
evaluation of number of accesses
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Type of pathologies
Time Frame: 1 year
|
Classification according to type of pathologies that causes the access to Emergency Room
|
1 year
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Poyser A, Deol SS, Osman L, Kuht HJ, Sivagnanasithiyar T, Manrique R, Okafor LO, DeSilva I, Sharpe D, Savant V, Sarodia U, Sarvananthan N, Chaudhuri R, Banerjee S, Burns J, Thomas MG. Impact of COVID-19 pandemic and lockdown on eye emergencies. Eur J Ophthalmol. 2021 Nov;31(6):2894-2900. doi: 10.1177/1120672120974944. Epub 2020 Nov 19.
- Ehlken C, von Medem C, Ludemann M, Kirsch AM, Roider JB. Patients' perspective on emergency treatment of ophthalmologic diseases during the first phase of SARS-CoV2 pandemic in a tertiary referral center in Germany - the COVID-DETOUR questionnaire study. BMC Ophthalmol. 2021 Aug 16;21(1):301. doi: 10.1186/s12886-021-02054-7.
- Salvetat ML, Salati C, Busatto P, Zeppieri M. The impact of COVID-19 related national lockdown on ophthalmic emergency in Italy: A multicenter study. Eur J Ophthalmol. 2022 May;32(3):1782-1794. doi: 10.1177/11206721211028046. Epub 2021 Jul 3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02/2021 - COVID and EYE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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