Cataract SurgeryNCT05217862
Effect Not Imposing COVID-19 Testing Prior to Elective Cataract Surgery
An observational study of Cataract Surgery and COVID-19, run by Assiut University at 1 site in Egypt.
Trial summary
The world health organization declared corona virus disease (COVID19) a pandemic since march 2020. Since then the future landscape of medical practices and procedures is being heavily shaped by the emergence of this pandemic. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cataract Surgery, COVID-19
- What is being tested?
- PCR for COVID-19 testing
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 29 Jan 2022
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Asymptomatic adult undergoing cataract surgery
Who may be able to join
- Asymptomatic adult undergoing cataract surgery
Who cannot join
- Symptomatic patients (fever, cough lethargy malaise , headache, and aches, sore throat and diarrhoea
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Implications of Not Imposing COVID-19 Testing on Patients Prior to Elective Cataract Surgery
The world health organization declared corona virus disease (COVID19) a pandemic since march 2020. Since then the future landscape of medical practices and procedures is being heavily shaped by the emergence of this pandemic. COVID 19 testing has already standardized within the medical field as doctors wearing scrubs or fitness examination before operation. We are now more than 2 years into COVID-19 pandemic with more than 6 effective vaccines available in the market for public to boost and build up their immunity against the virus. Every 3 to 4 months we hear about a new strain and another wave of the virus attacking the world, therefore healthcare institutions face enormous challenges in balancing patients' needs and simultaneous safety to health care workers.
The Indian council of medical research in June 2020 proposed that testing for Covid-19 for asymptomatic patients coming for elective surgeries should be performed for neurosurgery, ear nose, and throat (ENT) surgery, dental procedures, etc. and for non-surgical interventions like bronchoscopy, upper gastrointestinal endoscopy and dialysis. A role of preoperative testing of Covid-19 for every patient is still controversial especially in asymptomatic healthy patients with not known exposure to a COVID positive patient.
Read more
Most patients attending eye out patient department (EOPD) are aged 65y and older are considered at a higher risk for worse outcome in case of COVID-19 infection. Therefore a rethink of a cataract surgery pathway should include preoperative perioperative and postoperative care in order to maintain safety conditions for patients and for healthcare staff.
COVID-19 can infect anyone and result in transmission of infection before the patient become symptomatic or even without ever developing symptoms. Therefore preoperative screening of patients undergoing ophthalmic surgery should be considered.
- Conditions
- Cataract Surgery, COVID-19
- Being tested
- PCR for COVID-19 testing
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCR for COVID-19 testingDiagnostic test
PCR for asymptomatic adult undergoing elective cataract surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify +ve or -ve COVID patient
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Dec 2021
- Primary completion29 Jan 2022
- Study completion29 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SurgeryStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdelazeem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217862
- Sponsor's protocol ID
- 17300720
- Status last verified
- Jan 2022
- First submitted
- 29 Jan 2022
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Implications of Not Imposing COVID-19 Testing on Patients Prior to Elective Cataract Surgery
- ClinicalTrials.gov ID
- NCT05217862
- Acronym / sponsor ID
- 17300720
- Conditions
- Cataract Surgery, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 29 Jan 2022 (actual)
- Study completion
- 29 Jan 2022 (actual)
- First posted
- 1 Feb 2022 (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.
The world health organization declared corona virus disease (COVID19) a pandemic since march 2020. Since then the future landscape of medical practices and procedures is being heavily shaped by the emergence of this pandemic. COVID 19 testing has already standardized within the medical field as doctors wearing scrubs or fitness examination before operation. We are now more than 2 years into COVID-19 pandemic with more than 6 effective vaccines available in the market for public to boost and build up their immunity against the virus. Every 3 to 4 months we hear about a new strain and another wave of the virus attacking the world, therefore healthcare institutions face enormous challenges in balancing patients' needs and simultaneous safety to health care workers.
The Indian council of medical research in June 2020 proposed that testing for Covid-19 for asymptomatic patients coming for elective surgeries should be performed for neurosurgery, ear nose, and throat (ENT) surgery, dental procedures, etc. and for non-surgical interventions like bronchoscopy, upper gastrointestinal endoscopy and dialysis. A role of preoperative testing of Covid-19 for every patient is still controversial especially in asymptomatic healthy patients with not known exposure to a COVID positive patient.
Most patients attending eye out patient department (EOPD) are aged 65y and older are considered at a higher risk for worse outcome in case of COVID-19 infection. Therefore a rethink of a cataract surgery pathway should include preoperative perioperative and postoperative care in order to maintain safety conditions for patients and for healthcare staff.
COVID-19 can infect anyone and result in transmission of infection before the patient become symptomatic or even without ever developing symptoms. Therefore preoperative screening of patients undergoing ophthalmic surgery should be considered.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asymptomatic adult undergoing cataract surgery
Key inclusion criteria (1 listed)
- Asymptomatic adult undergoing cataract surgery
Key exclusion criteria (1 listed)
- Symptomatic patients (fever, cough lethargy malaise , headache, and aches, sore throat and diarrhoea
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 |
|---|---|---|
| PCR for COVID-19 testingPCR for asymptomatic adult undergoing elective cataract surgery | Diagnostic test | – |
Primary outcome
To identify +ve or -ve COVID patient
Time frame: 1 day
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 1 Feb 2022.
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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 Cataract Surgery and COVID-19, run by Assiut 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 1 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 1 Feb 2022. 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?
To identify +ve or -ve COVID patient (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2022.