Orbital FracturesVs: versusNCT07759440
Clinical Outcomes of Transconjunctival Vs Transcutaneous Approaches in Orbital Fracture Repair
A study testing orbital fracture reduction and fixation in people with Orbital Fractures, run by Alexandria University at 1 site in Egypt.
Trial summary
Open reduction and internal fixation of zygomaticomaxillary complex (ZMC) fractures has a challenging impact on the selection of the suitable surgical approach to the orbital and zygomatic skeleton. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Orbital Fractures
- What is being tested?
- orbital fracture reduction and fixation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 25 May 2026to 25 Nov 2026
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient with orbital fractures (e.g., orbital floor or zygomaticomaxillary complex fractures) require open reduction with internal fixation.
- Adult patient between 20 and 50 years with no gender predilections.
Who cannot join
- • Existing lacerations in the inferior and lateral periorbital regions.
- Comminuted fracture with bone loss.
- Existence of infection at the fracture line.
- Presence of acute or chronic conjunctival diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria university
Alexandria, Outside US and Canada, 2881055
Mona Oraby, 01000775330, mona.oraby@alexu.edu.eg
About this study
Official title: Clinical Outcomes of Transconjunctival Vs Transcutaneous Approaches in Orbital Fracture Repair : ( Randomized Clinical Trial)
Open reduction and internal fixation of zygomaticomaxillary complex (ZMC) fractures has a challenging impact on the selection of the suitable surgical approach to the orbital and zygomatic skeleton. Precise repair of the ZMC fractures needs a quite understanding of the regional anatomy, precise diagnosis, an accessible exposure, and an accurate rigid fixation of fracture to restore the normal form. The aesthetic results are one of the most important requirements for these incisions in facial fracture reduction. Conventional approaches to the infraorbital rim/orbital floor include transcutaneous as subciliary, subtarsal and infraorbital incisions and transconjunctival incision. A thorough understanding of each incisional technique requires an appreciation of the relevant anatomy putting in considerations the risk of associated complications.
Aim of this study:To compare between transconjunctival approach and transcutaneous approaches in open reduction of zygomaticomaxillary fracture.
Read more
Materials and methods: A study will be made on 75 patients who will undergo fracture repair of the zygomaticomaxillary complex. Twenty five of them (group A) will be treated via a subtarsal approach while. Other Twenty five patients (group B) via a transconjunctival approach. The remaining Twenty five patients (Group C) will be treated via infraorbital appeoach. Postoperative patient evaluation will be performed with specific attention paid towards, accessibility, the exposure duration (time from incision till exposure of the field), esthetic appearance ,postoperative pain, postoperative edema , wound healing, scaring, infection and postoperative ocular complications such as ectropion, entropion, scleral show and corneal abrasion. Postoperatively clinical examination along with radiographic examination will be done to evaluate the position of the zygoma and determine the adequacy of fracture reduction.
Results: will be statistically analyzed using the IBM Statistical Package for Social Science (SPSS) software version 22.0
- Conditions
- Orbital Fractures
- Being tested
- orbital fracture reduction and fixation
- Medical subject headings
- Orbital Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orbital fracture reduction and fixationOther
orbital fracture reduction and fixation
| Study group | Role | What they receive |
|---|---|---|
| subtarsal approach | Active comparator | Not described Receives: Other: orbital fracture reduction and fixation |
| infraorbital approach | Active comparator | Not described Receives: Other: orbital fracture reduction and fixation |
| transconjunctival approach | Active comparator | Not described Receives: Other: orbital fracture reduction and fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
operation time
starting from the skin incision till the reduction and fixation of the orbital rim
Measured: intraopertive in minutes
accessibility
objective assessment by the main surgeon ( mild, moderate, excellent) accessibility
Measured: intraopertive
Secondary outcomes (1)
wound healing 1
by Manchester scar scale
Measured: 1, 2 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start25 May 2026
- Primary completion25 Nov 2026 (estimated)
- Study completion25 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orbital FracturesStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mona oraby, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759440
- Sponsor's protocol ID
- IRB No. 00010556- IORG 0008839
- Acronym
- Vs: versus
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Transconjunctival Vs Transcutaneous Approaches in Orbital Fracture Repair : ( Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07759440
- Acronym / sponsor ID
- Vs: versus / IRB No. 00010556- IORG 0008839
- Conditions
- Orbital Fractures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 25 May 2026 (actual)
- Primary completion
- 25 Nov 2026 (estimated)
- Study completion
- 25 Nov 2026 (estimated)
- First posted
- 12 Aug 2026 (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.
Open reduction and internal fixation of zygomaticomaxillary complex (ZMC) fractures has a challenging impact on the selection of the suitable surgical approach to the orbital and zygomatic skeleton. Precise repair of the ZMC fractures needs a quite understanding of the regional anatomy, precise diagnosis, an accessible exposure, and an accurate rigid fixation of fracture to restore the normal form. The aesthetic results are one of the most important requirements for these incisions in facial fracture reduction. Conventional approaches to the infraorbital rim/orbital floor include transcutaneous as subciliary, subtarsal and infraorbital incisions and transconjunctival incision. A thorough understanding of each incisional technique requires an appreciation of the relevant anatomy putting in considerations the risk of associated complications.
Aim of this study:To compare between transconjunctival approach and transcutaneous approaches in open reduction of zygomaticomaxillary fracture.
Materials and methods: A study will be made on 75 patients who will undergo fracture repair of the zygomaticomaxillary complex. Twenty five of them (group A) will be treated via a subtarsal approach while. Other Twenty five patients (group B) via a transconjunctival approach. The remaining Twenty five patients (Group C) will be treated via infraorbital appeoach. Postoperative patient evaluation will be performed with specific attention paid towards, accessibility, the exposure duration (time from incision till exposure of the field), esthetic appearance ,postoperative pain, postoperative edema , wound healing, scaring, infection and postoperative ocular complications such as ectropion, entropion, scleral show and corneal abrasion. Postoperatively clinical examination along with radiographic examination will be done to evaluate the position of the zygoma and determine the adequacy of fracture reduction.
Results: will be statistically analyzed using the IBM Statistical Package for Social Science (SPSS) software version 22.0
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| subtarsal approach | Active comparator | Other: orbital fracture reduction and fixation |
| infraorbital approach | Active comparator | Other: orbital fracture reduction and fixation |
| transconjunctival approach | Active comparator | Other: orbital fracture reduction and fixation |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patient with orbital fractures (e.g., orbital floor or zygomaticomaxillary complex fractures) require open reduction with internal fixation.
- Adult patient between 20 and 50 years with no gender predilections.
Key exclusion criteria (4 listed)
- • Existing lacerations in the inferior and lateral periorbital regions.
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 |
|---|---|---|
| orbital fracture reduction and fixationorbital fracture reduction and fixation | Other | infraorbital approach, subtarsal approach, transconjunctival approach |
Primary outcome
operation time
Time frame: intraopertive in minutes
starting from the skin incision till the reduction and fixation of the orbital rim
accessibility
Time frame: intraopertive
objective assessment by the main surgeon ( mild, moderate, excellent) accessibility
1 secondary outcome
wound healing 1
Time frame: 1, 2 and 8 weeks
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 12 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Orbital Fractures
Recruiting
Comparing Pre-adaptation of In-stock Mesh Over In-house 3D Patient Specific Model to Reconstruct Unilateral Primary Orbital Fracture With and Without Intraoperative Navigation vs Conventional Intraoperative Free-hand Mesh Bending
Orbital Fractures, Unilateral
Not yet recruitingObservational study
Epidemiological and Statistical Study of Facial Traumatic Fractures at Assiut University Trauma Hospital
Facial Fractures, Maxillofacial Injuries
Not yet recruiting
A Trial to Evaluate Two Ectropion Preventive Measures Using the Subciliary Approach in Orbital Fracture Surgery.
Orbital Fractures, Orbital Floor Fractures
Active, not recruitingObservational study
Orbital Fractures Registry
Orbital Fractures, Blow Out Fracture of Orbit
Active, not recruiting
Endoscopically Assisted Management of Maxillofacial Fractures: A Prospective Study on Efficacy and Outcomes
Maxillofacial Injuries, Maxillofacial Trauma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing orbital fracture reduction and fixation in people with Orbital Fractures, run by Alexandria 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 12 Aug 2026. 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?
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 Mona s Oraby, PHd (+201000775330, mona.oraby@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operation time (time frame: intraopertive in minutes). The study lists 2 primary outcomes in all. 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 12 Aug 2026.