NCT05065788

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
Last Updated

October 4, 2021

Status Verified

September 1, 2021

Enrollment Period

1.6 years

First QC Date

September 30, 2021

Last Update Submit

September 30, 2021

Conditions

Keywords

ocular emergencyvision loss

Outcome Measures

Primary Outcomes (1)

  • number of patients

    evaluation of number of accesses

    1 year

Secondary Outcomes (1)

  • Type of pathologies

    1 year

Study Arms (2)

2020 Lockdown period

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

Other: data collection

2019

Patients who access to Ophthalmological emergency service in 2019 definite periods

Other: data collection

Interventions

data collection

20192020 Lockdown period

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Access to emergency room in the definite periods Completed Patients Charts -

You may not qualify if:

  • Access to emergency room in other periods Demographics and clinical data not completed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASST Sette Laghi

Varese, 21100, Italy

Location

Related Publications (3)

  • 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.

    PMID: 33213198BACKGROUND
  • 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.

MeSH Terms

Conditions

Wounds and InjuriesInfectionsBlindnessVision Disorders

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 30, 2021

First Posted

October 4, 2021

Study Start

February 1, 2020

Primary Completion

September 1, 2021

Study Completion

September 30, 2021

Last Updated

October 4, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations