Endophthalmitis and Orbital CellulitisNCT04456556
Combined Endophthalmitis and Orbital Cellulitis in Patients With Novel Coronavirus Disease (COVID-19)
An observational study of Endophthalmitis and Orbital Cellulitis, run by Minia University at 1 site in Egypt.
Trial summary
To report on cases presented with combined endophthalmitis and orbital cellulitis as a first presentation of covid-19 infection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endophthalmitis and Orbital Cellulitis
- How many people
- 5 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Apr 2020to 30 Jun 2020
- 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: 5 patients referred to the Ophthalmology Department, Minia University with severe ophthalmic manifestations in the form of combined endophthalmitis and orbital cellulitis. On doing the work-up of covid-19 infection according to the recommendations of Egyptian Ministry of Health, patients proved to be infected by the novel Corona virus.
Who may be able to join
- Patients with endophthalmitis and orbital cellulitis with covid-19
Who cannot join
- Patients without endophthalmitis and orbital cellulitis.
- Patients with endophthalmitis and orbital cellulitis not having covid-19 infection.
Trial locations and contacts
1 site in 1 country.
About this study
To report on cases presented with combined endophthalmitis and orbital cellulitis as a first presentation of covid-19 infection.
Read the detailed description
This observation case series study included 5 patients referred to the Ophthalmology Department, Minia University with severe ophthalmic manifestations in the form of combined endophthalmitis and orbital cellulitis. On doing the work-up of covid-19 infection according to the recommendations of Egyptian Ministry of Health, patients proved to be infected by the novel Corona virus. In addition to the Corona work-up, all patients were subjected to full ophthalmological evaluation, ocular ultrasound and orbital CT examination.
- Conditions
- Endophthalmitis and Orbital Cellulitis
- Keywords
- endophthalmitis, orbital cellulitis, covid-19
- Medical subject headings
- Endophthalmitis, Orbital Cellulitis, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined Endophthalmitis and Orbital Cellulitis in patients with Novel Coronavirus Disease (COVID-19)
highlight the occurrence of combined endophthalmitis and orbital cellulitis in patients with novel Coronavirus Disease (COVID-19)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start27 Apr 2020
- Primary completion20 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Endophthalmitis and Orbital CellulitisStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Farouk Sayed Othman Abelkader, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456556
- Sponsor's protocol ID
- ocular infection in covid19
- Status last verified
- Jun 2020
- First submitted
- 30 Jun 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen L, Liu M, Zhang Z, Qiao K, Huang T, Chen M, Xin N, Huang Z, Liu L, Zhang G, Wang J. Ocular manifestations of a hospitalised patient with confirmed 2019 novel coronavirus disease. Br J Ophthalmol. 2020 Jun;104(6):748-751. doi: 10.1136/bjophthalmol-2020-316304. Epub 2020 Apr 7.
PubMed 32265202Turbin RE, Wawrzusin PJ, Sakla NM, Traba CM, Wong KG, Mirani N, Eloy JA, Nimchinsky EA. Orbital cellulitis, sinusitis and intracranial abnormalities in two adolescents with COVID-19. Orbit. 2020 Aug;39(4):305-310. doi: 10.1080/01676830.2020.1768560. Epub 2020 May 18.
PubMed 32419568Elshafei AMK, Sayed MF, Abdallah RMA. Clinical profile and outcomes of management of orbital cellulitis in Upper Egypt. J Ophthalmic Inflamm Infect. 2017 Dec;7(1):8. doi: 10.1186/s12348-017-0126-3. Epub 2017 Mar 9.
PubMed 28275981Abdelkader MFSO, Elshafei AMK, Nassar MM, Abu Elela MA, Abdallah RMA. Combined endophthalmitis and orbital cellulitis in patients with corona virus disease (COVID-19). J Ophthalmic Inflamm Infect. 2021 Sep 15;11(1):27. doi: 10.1186/s12348-021-00258-y.
PubMed 34523045
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Endophthalmitis and Orbital Cellulitis in Patients With Novel Coronavirus Disease (COVID-19)
- ClinicalTrials.gov ID
- NCT04456556
- Acronym / sponsor ID
- ocular infection in covid19
- Conditions
- Endophthalmitis and Orbital Cellulitis
- Keywords
- endophthalmitis, orbital cellulitis, covid-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 20 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 2 Jul 2020 (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 report on cases presented with combined endophthalmitis and orbital cellulitis as a first presentation of covid-19 infection.
Detailed description
This observation case series study included 5 patients referred to the Ophthalmology Department, Minia University with severe ophthalmic manifestations in the form of combined endophthalmitis and orbital cellulitis. On doing the work-up of covid-19 infection according to the recommendations of Egyptian Ministry of Health, patients proved to be infected by the novel Corona virus. In addition to the Corona work-up, all patients were subjected to full ophthalmological evaluation, ocular ultrasound and orbital CT examination.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 5 patients referred to the Ophthalmology Department, Minia University with severe ophthalmic manifestations in the form of combined endophthalmitis and orbital cellulitis. On doing the work-up of covid-19 infection according to the recommendations of Egyptian Ministry of Health, patients proved to be infected by the novel Corona virus.
Key inclusion criteria (1 listed)
- Patients with endophthalmitis and orbital cellulitis with covid-19
Key exclusion criteria (2 listed)
- Patients without endophthalmitis and orbital cellulitis.
- Patients with endophthalmitis and orbital cellulitis not having covid-19 infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Combined Endophthalmitis and Orbital Cellulitis in patients with Novel Coronavirus Disease (COVID-19)
Time frame: baseline
highlight the occurrence of combined endophthalmitis and orbital cellulitis in patients with novel Coronavirus Disease (COVID-19)
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 2 Jul 2020.
- Background: PubMed 32265202Chen L, Liu M, Zhang Z, Qiao K, Huang T, Chen M, Xin N, Huang Z, Liu L, Zhang G, Wang J. Ocular manifestations of a hospitalised patient with confirmed 2019 novel coronavirus disease. Br J Ophthalmol. 2020 Jun;104(6):748-751. doi: 10.1136/bjophthalmol-2020-316304. Epub 2020 Apr 7.
- Background: PubMed 32419568Turbin RE, Wawrzusin PJ, Sakla NM, Traba CM, Wong KG, Mirani N, Eloy JA, Nimchinsky EA. Orbital cellulitis, sinusitis and intracranial abnormalities in two adolescents with COVID-19. Orbit. 2020 Aug;39(4):305-310. doi: 10.1080/01676830.2020.1768560. Epub 2020 May 18.
- Background: PubMed 28275981Elshafei AMK, Sayed MF, Abdallah RMA. Clinical profile and outcomes of management of orbital cellulitis in Upper Egypt. J Ophthalmic Inflamm Infect. 2017 Dec;7(1):8. doi: 10.1186/s12348-017-0126-3. Epub 2017 Mar 9.
- Derived from this study: PubMed 34523045Abdelkader MFSO, Elshafei AMK, Nassar MM, Abu Elela MA, Abdallah RMA. Combined endophthalmitis and orbital cellulitis in patients with corona virus disease (COVID-19). J Ophthalmic Inflamm Infect. 2021 Sep 15;11(1):27. doi: 10.1186/s12348-021-00258-y.
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 Endophthalmitis and Orbital Cellulitis, run by Minia University at 1 site in Egypt.
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 2 Jul 2020. 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 Egypt. 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?
Combined Endophthalmitis and Orbital Cellulitis in patients with Novel Coronavirus Disease (COVID-19) (time frame: baseline). 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 NCT04456556, which also lists 4 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 2 Jul 2020.