Ophthalmological Emergencies and COVID-19 Pandemia

Sponsor

Università degli Studi dell'Insubria (Other)

Overall Status

Completed

CT.gov ID

NCT05065788

Collaborator

(none)

500

Enrollment

Location

19.9

Actual Duration (Months)

25.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To analyze how the COVID 19 pandemia has affected the patient's accesses to the Ophthalmological Emergency Department of a tertiary referral center in northern Italy, during the lockdown period. We will collect data from different periods in 2020, in which the Italian Governement called the total lockdown to same periods of the 2019. The charts of all patients will be evaluated to analyze demographics and clinical data

Condition or Disease	Intervention/Treatment	Phase
Trauma Infections Vision; Loss, Both Eyes	Other: data collection

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 Design

Study Type:

Observational

Actual Enrollment :

500 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

Impact of COVID-19 Pandemic and Related Lockdown on Eye Emergencies Accesses

Actual Study Start Date :

Feb 1, 2020

Actual Primary Completion Date :

Sep 1, 2021

Actual Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
2020 Lockdown period Patients who access to Ophthalmological emergency service during lockdown period in 2020	Other: data collection data collection
2019 Patients who access to Ophthalmological emergency service in 2019 definite periods	Other: data collection data collection

Arm

Intervention/Treatment

2020 Lockdown period

Patients who access to Ophthalmological emergency service during lockdown period in 2020

Other: data collection

data collection

2019

Patients who access to Ophthalmological emergency service in 2019 definite periods

Other: data collection

data collection

Outcome Measures

Primary Outcome Measures

number of patients [1 year]
evaluation of number of accesses

Secondary Outcome Measures

Type of pathologies [1 year]
Classification according to type of pathologies that causes the access to Emergency Room

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ASST Sette Laghi	Varese		Italy	21100

Sponsors and Collaborators

Università degli Studi dell'Insubria

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Simone Donati, Associate Professor, Università degli Studi dell'Insubria

ClinicalTrials.gov Identifier:

NCT05065788

Other Study ID Numbers:

02/2021 - COVID and EYE

First Posted:

Oct 4, 2021

Last Update Posted:

Oct 4, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Simone Donati, Associate Professor, Università degli Studi dell'Insubria

ocular emergency

vision loss

Additional relevant MeSH terms:

Emergencies

Study Results

No Results Posted as of Oct 4, 2021