TraumaNCT05065788
Ophthalmological Emergencies and COVID-19 Pandemia
An observational study of Trauma and Infections, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trauma, Infections, Vision; Loss, Both Eyes
- What is being tested?
- data collection
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2020to 30 Sep 2021
- 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
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Access to emergency room in the definite periods Completed Patients Charts -
Who cannot join
- Access to emergency room in other periods Demographics and clinical data not completed
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of COVID-19 Pandemic and Related Lockdown on Eye Emergencies Accesses
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
Read the 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.
- Conditions
- Trauma, Infections, Vision; Loss, Both Eyes
- Being tested
- data collection
- Keywords
- ocular emergency, vision loss
- Medical subject headings
- Wounds and Injuries, Infections, Blindness, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
data collection
| Study group | Role | What they receive |
|---|---|---|
| 2020 Lockdown period | Patients who access to Ophthalmological emergency service during lockdown period in 2020 Receives: Other: data collection | |
| 2019 | Patients who access to Ophthalmological emergency service in 2019 definite periods Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients
evaluation of number of accesses
Measured: 1 year
Secondary outcomes (1)
Type of pathologies
Classification according to type of pathologies that causes the access to Emergency Room
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start1 Feb 2020
- Primary completion1 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Donati, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065788
- Sponsor's protocol ID
- 02/2021 - COVID and EYE
- Status last verified
- Sep 2021
- First submitted
- 30 Sep 2021
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33213198Ehlken 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.
PubMed 34399720Salvetat 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.
PubMed 34219482
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of COVID-19 Pandemic and Related Lockdown on Eye Emergencies Accesses
- ClinicalTrials.gov ID
- NCT05065788
- Acronym / sponsor ID
- 02/2021 - COVID and EYE
- Conditions
- Trauma, Infections, Vision; Loss, Both Eyes
- Keywords
- ocular emergency, vision loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 4 Oct 2021 (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 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
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2020 Lockdown period | – | Other: data collectionPatients who access to Ophthalmological emergency service during lockdown period in 2020 |
| 2019 | – | Other: data collectionPatients who access to Ophthalmological emergency service in 2019 definite periods |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Access to emergency room in the definite periods Completed Patients Charts -
Key exclusion criteria (2 listed)
- Access to emergency room in other periods Demographics and clinical data not completed
- -
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 |
|---|---|---|
| data collectiondata collection | Other | 2019, 2020 Lockdown period |
Primary outcome
number of patients
Time frame: 1 year
evaluation of number of accesses
1 secondary outcome
Type of pathologies
Time frame: 1 year
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 4 Oct 2021.
- Background: PubMed 33213198Poyser 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.
- Results publication: PubMed 34399720Ehlken 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.
- Results publication: PubMed 34219482Salvetat 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.
- Individual participant dataSharing planned: No
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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 Trauma and Infections, run by Università degli Studi dell'Insubria at 1 site in Italy.
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 2 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 4 Oct 2021. 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 Italy. 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?
number of patients (time frame: 1 year). 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 NCT05065788, which also lists 3 linked publications.
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 4 Oct 2021; AzTrials last refreshed its copy on 7 Nov 2026.