Traumatic Eyelid InjuriesNCT06762093
Management and Outcomes of Traumatic Eyelid Injuries in Assiut University Hospital
A study testing surgical repaire in people with Traumatic Eyelid Injuries, run by Assiut University.
Trial summary
this study aim To determine the incidence of traumatic eyelid injuries presenting to a tertiary eye care center. To describe the clinical characteristics of traumatic eyelid injuries, including the etiology, location, and extent of injury. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Traumatic Eyelid Injuries
- What is being tested?
- surgical repaire
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patients of all ages presenting with traumatic eyelid injuries to the study institution in either ophthalmology or emergency departments
Who cannot join
- Patients presented with eyelid injuries who are:
- Presented late
- Presented after a previous intervention
- Known to have co-existing eyelid pathology (as tumors, infections, congenital abnormalities)
- Patients with incomplete medical records or loss to follow-up
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
this study aim To determine the incidence of traumatic eyelid injuries presenting to a tertiary eye care center.
To describe the clinical characteristics of traumatic eyelid injuries, including the etiology, location, and extent of injury.
To evaluate the management approaches utilized for traumatic eyelid injuries, including surgical repair, medical therapy, and other treatments.
To assess the outcomes of traumatic eyelid injuries, including functional outcomes, cosmetic results, and complication rates
Read the detailed description
Vision is the most cared-for function of the human body, and the eyelids are provided to cover the eye for protection. Eyelids are not only protective curtains in front of the eyes but also contribute to the shape and beauty of the face. They are complex structures designed to protect the globe from various external trauma . Eyelids help to keep the corneas moist, protect against injury and excessive light, and regulate the amount of light reaching the retina. They are essential for the distribution and drainage of tears .
Traumatic eyelid injuries are a common occurrence and can range in severity from minor lacerations to more complex injuries involving the eyelid structures. These injuries can significantly impact a patient's visual function and cosmetic appearance. Understanding the epidemiology, clinical presentation, management approaches, and outcomes of traumatic eyelid injuries is important for optimizing patient care.
Eyelid injuries are an important subtype of facial trauma, which necessitates the ophthalmologist being competent and fully informed . Lacerated wounds of the eyelids are common features of ocular trauma and often occur in isolation without any associated intraocular injuries . Eyelid lacerations can be treated using different techniques depending on their depth, width, injury mechanism, and accompanying injuries. They can be repaired with primary closure, skin flap, or skin graft. Small defects limited to the skin of the eyelids can be repaired by direct closure .
Eyelid trauma may often appear trivial but can have profound effects on injury-associated morbidity. Recovery of full eyelid function and maintenance of the lacrimal apparatus are important considerations when approaching lid trauma [. Proper information and education can help individuals to avoid eye injuries and their substantial burden .
- Conditions
- Traumatic Eyelid Injuries
- Being tested
- surgical repaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical repaireProcedure or surgery
Also called Surgical Repair
- Primary closure of lacerations
- Eyelid margin repair
- Eyelid crease reconstruction
- Eyelid transposition flaps or grafts
- Tarsorrhaphy
| Study group | Role | What they receive |
|---|---|---|
| traumatic eyelid injuries | Active comparator | * Patients of all ages presenting with traumatic eyelid injuries to the study institution in either ophthalmology or emergency departments.
* Traumatic eyelid injuries can include, but are not limited to:
* Contusions
* Lacerations
* Avulsions
* Eyelid margin defects
* Eyelid margin involvement
* Eyelid crease disruption
* Eyelid tissue loss Receives: Procedure: surgical repaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of traumatic eyelid injuries
To determine the incidence of traumatic eyelid injuries presenting to a tertiary eye care center.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Eyelid InjuriesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ismail Moussa Abdellateef, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762093
- Sponsor's protocol ID
- Traumatic Eyelid Injuries MO
- Status last verified
- Jan 2025
- First submitted
- 1 Jan 2025
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management and Outcomes of Traumatic Eyelid Injuries in Assiut University Hospital
- ClinicalTrials.gov ID
- NCT06762093
- Acronym / sponsor ID
- Traumatic Eyelid Injuries MO
- Conditions
- Traumatic Eyelid Injuries
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 7 Jan 2025 (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.
this study aim To determine the incidence of traumatic eyelid injuries presenting to a tertiary eye care center.
To describe the clinical characteristics of traumatic eyelid injuries, including the etiology, location, and extent of injury.
To evaluate the management approaches utilized for traumatic eyelid injuries, including surgical repair, medical therapy, and other treatments.
To assess the outcomes of traumatic eyelid injuries, including functional outcomes, cosmetic results, and complication rates
Detailed description
Vision is the most cared-for function of the human body, and the eyelids are provided to cover the eye for protection. Eyelids are not only protective curtains in front of the eyes but also contribute to the shape and beauty of the face. They are complex structures designed to protect the globe from various external trauma . Eyelids help to keep the corneas moist, protect against injury and excessive light, and regulate the amount of light reaching the retina. They are essential for the distribution and drainage of tears .
Traumatic eyelid injuries are a common occurrence and can range in severity from minor lacerations to more complex injuries involving the eyelid structures. These injuries can significantly impact a patient's visual function and cosmetic appearance. Understanding the epidemiology, clinical presentation, management approaches, and outcomes of traumatic eyelid injuries is important for optimizing patient care.
Eyelid injuries are an important subtype of facial trauma, which necessitates the ophthalmologist being competent and fully informed . Lacerated wounds of the eyelids are common features of ocular trauma and often occur in isolation without any associated intraocular injuries . Eyelid lacerations can be treated using different techniques depending on their depth, width, injury mechanism, and accompanying injuries. They can be repaired with primary closure, skin flap, or skin graft. Small defects limited to the skin of the eyelids can be repaired by direct closure .
Eyelid trauma may often appear trivial but can have profound effects on injury-associated morbidity. Recovery of full eyelid function and maintenance of the lacrimal apparatus are important considerations when approaching lid trauma [. Proper information and education can help individuals to avoid eye injuries and their substantial burden .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| traumatic eyelid injuries | Active comparator | Procedure: surgical repaire* Patients of all ages presenting with traumatic eyelid injuries to the study institution in either ophthalmology or emergency departments. * Traumatic eyelid injuries can include, but are not limited to: * Contusions * Lacerations * Avulsions * Eyelid margin defects * Eyelid margin involvement * Eyelid crease disruption * Eyelid tissue loss |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of all ages presenting with traumatic eyelid injuries to the study institution in either ophthalmology or emergency departments
Key exclusion criteria (5 listed)
- Patients presented with eyelid injuries who are:
- Presented late
- Presented after a previous intervention
- Known to have co-existing eyelid pathology (as tumors, infections, congenital abnormalities)
- Patients with incomplete medical records or loss to follow-up
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 |
|---|---|---|
| surgical repaireAlso: Surgical Repair* Primary closure of lacerations * Eyelid margin repair * Eyelid crease reconstruction * Eyelid transposition flaps or grafts * Tarsorrhaphy | Procedure or surgery | traumatic eyelid injuries |
Primary outcome
incidence of traumatic eyelid injuries
Time frame: 2 year
To determine the incidence of traumatic eyelid injuries presenting to a tertiary eye care center.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
A study testing surgical repaire in people with Traumatic Eyelid Injuries, run by Assiut University.
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 5 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: opening soon, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mahmoud Ismail Moussa, residant doctor (+201009847524, Mahmoud.16285235@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of traumatic eyelid injuries (time frame: 2 year). 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 7 Jan 2025.