Eye InjuriesNCT05164588
A Prospective Study of Traumatic Eye Injuries in the Period From January 2022 to June 2022 in Sohag University Hospitals
An observational study of Eye Injuries, run by Sohag University at 1 site in Egypt.
Trial summary
Ocular trauma is one of the main causes of severe ocular morbidity. It represents a serious public health problem and leading cause of visual impairment. It is an important and preventable cause of visual impairment in both developing and developed countries. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Eye Injuries
- What is being tested?
- Statistics
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2022to Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All diagnosed cases of eye trauma, regardless of gender, laterality, duration of presentation and other chronic systemic illness
Who may be able to join
- All diagnosed cases of eye trauma, regardless of gender, laterality, duration of presentation and other chronic systemic illness
Who cannot join
- patients with previous history of eye trauma or other pathological condition affecting visual acuity
Trial locations and contacts
1 site in 1 country.
Soheir A Mohamed contact
About this study
Ocular trauma is one of the main causes of severe ocular morbidity. It represents a serious public health problem and leading cause of visual impairment. It is an important and preventable cause of visual impairment in both developing and developed countries.
- Conditions
- Eye Injuries
- Being tested
- Statistics
- Medical subject headings
- Eye Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StatisticsOther
Study and analyze the medicolegal aspects of different eye trauma cases ( patterns of injuries, mechanisms, causes, site of trauma and outcome)
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate eye trauma cases at Sohag University Hospitals through statistical methods
We will analyze data about participants, mechanism of injuries, site of trauma and if the time of arrival if delayed or certain treatment will affect the outcome and then we will determine the causes of better outcome to improve the outcome of future cases
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study startJan 2022 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionSep 2022 (estimated)
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 Eye InjuriesStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safaa Lotfy Ali, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164588
- Sponsor's protocol ID
- Soh-Med-21-12-02
- Status last verified
- Dec 2021
- First submitted
- 12 Dec 2021
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mir TA, Canner JK, Zafar S, Srikumaran D, Friedman DS, Woreta FA. Characteristics of Open Globe Injuries in the United States From 2006 to 2014. JAMA Ophthalmol. 2020 Mar 1;138(3):268-275. doi: 10.1001/jamaophthalmol.2019.5823.
PubMed 31971539Matsa E, Shi J, Wheeler KK, McCarthy T, McGregor ML, Leonard JC. Trends in US Emergency Department Visits for Pediatric Acute Ocular Injury. JAMA Ophthalmol. 2018 Aug 1;136(8):895-903. doi: 10.1001/jamaophthalmol.2018.2062.
PubMed 29879287Low L, Hodson J, Morris D, Desai P, MacEwen C. Socioeconomic deprivation and serious ocular trauma in Scotland: a national prospective study. Br J Ophthalmol. 2017 Oct;101(10):1395-1398. doi: 10.1136/bjophthalmol-2016-309875. Epub 2017 Mar 8.
PubMed 28274942
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Traumatic Eye Injuries in the Period From January 2022 to June 2022 in Sohag University Hospitals
- ClinicalTrials.gov ID
- NCT05164588
- Acronym / sponsor ID
- Soh-Med-21-12-02
- Conditions
- Eye Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 20 Dec 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.
Ocular trauma is one of the main causes of severe ocular morbidity. It represents a serious public health problem and leading cause of visual impairment. It is an important and preventable cause of visual impairment in both developing and developed countries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All diagnosed cases of eye trauma, regardless of gender, laterality, duration of presentation and other chronic systemic illness
Key inclusion criteria (1 listed)
- All diagnosed cases of eye trauma, regardless of gender, laterality, duration of presentation and other chronic systemic illness
Key exclusion criteria (1 listed)
- patients with previous history of eye trauma or other pathological condition affecting visual acuity
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 |
|---|---|---|
| StatisticsStudy and analyze the medicolegal aspects of different eye trauma cases ( patterns of injuries, mechanisms, causes, site of trauma and outcome) | Other | – |
Primary outcome
Evaluate eye trauma cases at Sohag University Hospitals through statistical methods
Time frame: 6 months
We will analyze data about participants, mechanism of injuries, site of trauma and if the time of arrival if delayed or certain treatment will affect the outcome and then we will determine the causes of better outcome to improve the outcome of future cases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Background: PubMed 31971539Mir TA, Canner JK, Zafar S, Srikumaran D, Friedman DS, Woreta FA. Characteristics of Open Globe Injuries in the United States From 2006 to 2014. JAMA Ophthalmol. 2020 Mar 1;138(3):268-275. doi: 10.1001/jamaophthalmol.2019.5823.
- Background: PubMed 29879287Matsa E, Shi J, Wheeler KK, McCarthy T, McGregor ML, Leonard JC. Trends in US Emergency Department Visits for Pediatric Acute Ocular Injury. JAMA Ophthalmol. 2018 Aug 1;136(8):895-903. doi: 10.1001/jamaophthalmol.2018.2062.
- Background: PubMed 28274942Low L, Hodson J, Morris D, Desai P, MacEwen C. Socioeconomic deprivation and serious ocular trauma in Scotland: a national prospective study. Br J Ophthalmol. 2017 Oct;101(10):1395-1398. doi: 10.1136/bjophthalmol-2016-309875. Epub 2017 Mar 8.
- Individual participant dataSharing planned: Undecided
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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.
Soheir A Mohamed contact
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 Eye Injuries, run by Sohag 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: status not confirmed, as of the sponsor's last update on 20 Dec 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Safaa L Ali, Demonstrator (01114625799, safaalotfy@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate eye trauma cases at Sohag University Hospitals through statistical methods (time frame: 6 months). 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 NCT05164588, 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 20 Dec 2021.