Orbital FracturesPREVENTECTNCT07775417
A Trial to Evaluate Two Ectropion Preventive Measures Using the Subciliary Approach in Orbital Fracture Surgery.
A study testing Subciliary Approach, Lateral Canthopexy and Orbicularis Oculi Suspension in people with Orbital Fractures and Orbital Floor Fractures, run by Minia University.
Trial summary
The goal of this clinical trial is to investigate whether preventive surgical techniques can reduce the incidence of lower eyelid ectropion after the subciliary approach in adult patients undergoing surgery for orbital fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orbital Fractures, Orbital Floor Fractures
- What is being tested?
- Subciliary Approach, Lateral Canthopexy and Orbicularis Oculi Suspension
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systemically healthy patients aged 18 years or older, with no history of chronic or uncontrolled systemic diseases.
- Patients with primary orbital trauma requiring surgical treatment through a standardized subciliary approach, presenting with orbital floor fractures with or without associated lateral orbital rim fractures involving the lateral canthal tendon region, and without associated zygomaticomaxillary complex (ZMC) fractures.
Who cannot join
- Secondary orbital trauma (revision cases or patients with previous orbital trauma).
- Previous lower eyelid surgery.
- Pre-existing eyelid malposition (ectropion or entropion) or other pre-existing lower eyelid or lateral canthal abnormalities.
- Uncontrolled systemic conditions that may affect wound healing, eyelid integrity, or lower eyelid laxity, including uncontrolled diabetes mellitus, immunocompromised status, chronic corticosteroid therapy, or collagen vascular diseases.
- Previous radiotherapy to the orbital or facial region.
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
Official title: A Comparative Clinical Trial Evaluating Preventive Techniques for Postoperative Ectropion Following the Subciliary Approach in Orbital Trauma.
The goal of this clinical trial is to investigate whether preventive surgical techniques can reduce the incidence of lower eyelid ectropion after the subciliary approach in adult patients undergoing surgery for orbital fractures.
The main questions it aims to answer are:
Read more
Do lateral canthopexy or orbicularis oculi suspension reduce the incidence of postoperative ectropion? Which preventive technique provides better postoperative lower eyelid outcomes?
Researchers will compare three groups: subciliary approach alone, subciliary approach with lateral canthopexy, and subciliary approach with orbicularis oculi suspension to investigate which approach is most effective in preventing postoperative ectropion.
Participants will undergo surgical treatment according to their assigned group and will attend scheduled postoperative follow-up visits for clinical evaluation of lower eyelid position and surgical outcomes.
Read the detailed description
Orbital fractures commonly require surgical reconstruction to restore orbital anatomy and function. The subciliary approach provides excellent surgical exposure but may be associated with postoperative lower eyelid malposition, particularly ectropion, which can affect both function and appearance. Several preventive surgical techniques, including lateral canthopexy and orbicularis oculi muscle suspension, have been proposed to reduce this complication; however, evidence comparing their effectiveness remains limited.
This prospective randomized controlled clinical trial will compare three treatment groups: subciliary approach, subciliary approach with lateral canthopexy, and subciliary approach with orbicularis oculi suspension. Participants will be followed postoperatively to evaluate the incidence of ectropion and other lower eyelid outcomes. The findings will provide evidence regarding the effects of these techniques on postoperative lower eyelid position and ectropion following orbital fracture repair.
The orbital fracture repair will be performed through a standardized subciliary approach in all study groups. According to randomization, participants will receive either lateral canthopexy, orbicularis oculi suspension, or no additional lower eyelid procedure. The specific surgical techniques, including suture placement, tissue fixation, suture material, tension, and periosteal fixation, will be standardized across participants within each intervention group. All surgical procedures will be performed by the same surgeon across all three study groups to ensure consistency of the surgical technique and minimize operator-related variability.
Postoperative Management: All participants in the three study groups will receive standardized postoperative management, including Frost suture, eyelid taping, eyelid massage, corticosteroid therapy, and postoperative dressing. The same postoperative management protocol will be applied to all treatment groups to ensure consistency of postoperative care.
Before randomization and surgery, all participants will undergo a standardized preoperative assessment of the lower eyelid and lateral canthal position. The assessment will include measurement of baseline margin reflex distance 2 (MRD2), evaluation of scleral show, lower eyelid position, canthal tilt, and lateral canthal position. Standardized clinical assessment of lower eyelid laxity will also be performed using the snap-back test and eyelid distraction test. Standardized preoperative photographs will be obtained using consistent patient positioning and standardized views to document baseline eyelid and lateral canthal anatomy.
- Conditions
- Orbital Fractures, Orbital Floor Fractures
- Being tested
- Subciliary Approach, Lateral Canthopexy, Orbicularis Oculi Suspension
- Keywords
- Orbital Fractures, Orbital Floor Fracture, Subciliary Approach, Ectropion, Lateral Canthopexy, Orbicularis Oculi Suspension, Lower Eyelid Malposition, Orbital Reconstruction, Oral and Maxillofacial Surgery, Randomized Controlled Trial
- Medical subject headings
- Orbital Fractures, Ectropion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subciliary ApproachProcedure or surgery
Standardized subciliary approach for orbital fracture repair. The skin incision will be placed approximately 2 mm below the lower eyelid margin within a natural skin crease, extending from approximately 1 mm temporal to the inferior punctum toward the lateral canthal region. A stepped skin-muscle approach will be used, with the skin incision followed by inferior subcutaneous dissection and subsequent incision of the preseptal orbicularis oculi muscle approximately 7 mm inferior to the subciliary margin. Dissection will proceed to the infraorbital rim while maintaining the integrity of the orbital septum. The periosteum will be incised approximately 3-4 mm below the inferior orbital rim on its facial aspect to obtain surgical exposure.
Lateral CanthopexyProcedure or surgery
Lateral Canthopexy Technique: A 4-0 polydioxanone (PDS) suture on a P2 needle will be placed through the periosteum of the inner aspect of the lateral orbital rim over Whitnall's tubercle at the desired height. The suture will then engage the medial end of the lateral canthal tendon and the lateral border of the lower eyelid tarsus in a vertical direction. The suture will be tied with the lower eyelid positioned at the desired height. Periosteal fixation will be used.
Orbicularis Oculi SuspensionProcedure or surgery
A standardized orbicularis oculi suspension procedure performed in conjunction with the subciliary approach. Following the subciliary incision, the orbicularis oculi muscle is split 7 mm inferior to the subciliary margin while preserving pretarsal muscle function. The lateral edge of the preseptal orbicularis oculi muscle is bluntly dissected to the lateral orbital rim and suspended to the periosteum at the anchoring point using a Vicryl 5-0 or 6-0 horizontal mattress suture with appropriate tension.
| Study group | Role | What they receive |
|---|---|---|
| Subciliary Approach | Active comparator | Participants will undergo orbital fracture repair using the subciliary approach. Receives: Procedure: Subciliary Approach |
| Subciliary Approach with Lateral Canthopexy | Experimental | Participants will undergo orbital fracture repair using the subciliary approach combined with lateral canthopexy. The effect of lateral canthopexy on postoperative lower eyelid position and the incidence of ectropion will be evaluated. Receives: Procedure: Subciliary Approach; Procedure: Lateral Canthopexy |
| Subciliary Approach with Orbicularis Oculi Suspension | Experimental | Participants will undergo orbital fracture repair using the subciliary approach combined with orbicularis oculi suspension. The effect of orbicularis oculi suspension on postoperative lower eyelid position and the incidence of ectropion will be evaluated. Receives: Procedure: Subciliary Approach; Procedure: Orbicularis Oculi Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative lower eyelid ectropion
The proportion of participants who develop postoperative lower eyelid ectropion after orbital fracture repair. Ectropion will be assessed clinically by an examiner blinded to treatment allocation using the Ectropion Grading Scale (EGS), a standardized grading system for assessing the severity of lower eyelid ectropion. The severity will be graded from Grade 0 (normal eyelid position) to Grade V (severe ectropion with associated complications). Standardized postoperative photographs will also be obtained using consistent patient positioning and standardized views at each assessment time point to facilitate comparison of postoperative lower eyelid position and ectropion severity over time.
Measured: 1 week, 1 month, 3 months, and 6 months postoperatively
Secondary outcomes (6)
Change in lower margin reflex distance 2 (MRD2) from baseline
Change in lower margin reflex distance 2 (MRD2) from baseline will be measured clinically by an examiner blinded to treatment allocation. MRD2 will be defined as the distance, in millimeters, between the central corneal light reflex and the lower eyelid margin, measured with the patient in primary gaze using a standardized measurement technique. Standardized frontal photographs will also be obtained at each assessment time point using consistent patient positioning to facilitate documentation and evaluation of postoperative lower eyelid position.
Measured: 1 week, 1 month, 3 months, and 6 months postoperatively
Inferior scleral show
The amount of inferior scleral show will be assessed clinically by an examiner blinded to treatment allocation and measured in millimeters as the visible scleral area between the lower eyelid margin and the inferior limbus in primary gaze. Standardized frontal photographs will also be obtained at each assessment time point to facilitate comparison of lower eyelid position over time.
Measured: 1 week, 1 month, 3 months, and 6 months postoperatively
Postoperative lower eyelid retraction
The presence and severity of postoperative lower eyelid retraction will be assessed clinically by an examiner blinded to treatment allocation, based on inferior displacement of the lower eyelid margin relative to its baseline position. Assessment will be supported by standardized clinical measurements and photographs.
Measured: 1 week, 1 month, 3 months, and 6 months postoperatively
Ectropion severity
The severity of postoperative lower eyelid ectropion will be assessed clinically by an examiner blinded to treatment allocation using the Ectropion Grading Scale (EGS), a standardized grading system ranging from Grade 0 (normal eyelid position) to Grade V (severe ectropion with associated complications). Standardized postoperative photographs will also be obtained to facilitate assessment of ectropion severity over time.
Measured: 1 week, 1 month, 3 months, and 6 months postoperatively
Subciliary scar assessment
The subciliary surgical scar will be assessed clinically for visibility, quality, and the presence of hypertrophic scarring by an examiner blinded to treatment allocation. Standardized photographs will also be obtained to facilitate assessment of scar appearance.
Measured: 1 month, 3 months, and 6 months postoperatively
Patient satisfaction
Patient-reported functional and aesthetic satisfaction following surgery will be assessed using a Visual Analogue Scale (VAS) ranging from 0 to 10. Patients will rate their functional satisfaction and aesthetic satisfaction separately, with 0 indicating complete dissatisfaction and 10 indicating complete satisfaction. The same assessment will be performed at each postoperative time point to allow comparison of patient-reported satisfaction over time and among the three treatment groups.
Measured: 1 month, 3 months, and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orbital FracturesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a parallel design to one of three intervention groups: subciliary approach alone, subciliary approach with lateral canthopexy, or subciliary approach with orbicularis oculi suspension. Outcomes will be compared between the groups during scheduled postoperative follow-up.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Ahmed Moustafa Kamal Abdelfattah, Minia University
- Investigators
- Hamed Gad, PhD, Principal investigator, Faculty of Dentistry, Minia UniversityAlaa Othman, PhD, Study director, Samalout Specialized HospitalMohamed S. Elkhouly, PhD, Study director, Faculty of Dentistry, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775417
- Sponsor's protocol ID
- OMFS-ECT-2026-01
- Acronym
- PREVENTECT
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to confidentiality and institutional ethical requirements.
Publications
Al-Moraissi E, Elsharkawy A, Al-Tairi N, Farhan A, Abotaleb B, Alsharaee Y, Oginni FO, Al-Zabidi A. What surgical approach has the lowest risk of the lower lid complications in the treatment of orbital floor and periorbital fractures? A frequentist network meta-analysis. J Craniomaxillofac Surg. 2018 Dec;46(12):2164-2175. doi: 10.1016/j.jcms.2018.09.001. Epub 2018 Sep 21.
PubMed 30337055
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Clinical Trial Evaluating Preventive Techniques for Postoperative Ectropion Following the Subciliary Approach in Orbital Trauma.
- ClinicalTrials.gov ID
- NCT07775417
- Acronym / sponsor ID
- PREVENTECT / OMFS-ECT-2026-01
- Conditions
- Orbital Fractures, Orbital Floor Fractures
- Keywords
- Orbital Fractures, Orbital Floor Fracture, Subciliary Approach, Ectropion, Lateral Canthopexy, Orbicularis Oculi Suspension, Lower Eyelid Malposition, Orbital Reconstruction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 20 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.
The goal of this clinical trial is to investigate whether preventive surgical techniques can reduce the incidence of lower eyelid ectropion after the subciliary approach in adult patients undergoing surgery for orbital fractures.
The main questions it aims to answer are:
Do lateral canthopexy or orbicularis oculi suspension reduce the incidence of postoperative ectropion? Which preventive technique provides better postoperative lower eyelid outcomes?
Researchers will compare three groups: subciliary approach alone, subciliary approach with lateral canthopexy, and subciliary approach with orbicularis oculi suspension to investigate which approach is most effective in preventing postoperative ectropion.
Participants will undergo surgical treatment according to their assigned group and will attend scheduled postoperative follow-up visits for clinical evaluation of lower eyelid position and surgical outcomes.
Detailed description
Orbital fractures commonly require surgical reconstruction to restore orbital anatomy and function. The subciliary approach provides excellent surgical exposure but may be associated with postoperative lower eyelid malposition, particularly ectropion, which can affect both function and appearance. Several preventive surgical techniques, including lateral canthopexy and orbicularis oculi muscle suspension, have been proposed to reduce this complication; however, evidence comparing their effectiveness remains limited.
This prospective randomized controlled clinical trial will compare three treatment groups: subciliary approach, subciliary approach with lateral canthopexy, and subciliary approach with orbicularis oculi suspension. Participants will be followed postoperatively to evaluate the incidence of ectropion and other lower eyelid outcomes. The findings will provide evidence regarding the effects of these techniques on postoperative lower eyelid position and ectropion following orbital fracture repair.
The orbital fracture repair will be performed through a standardized subciliary approach in all study groups. According to randomization, participants will receive either lateral canthopexy, orbicularis oculi suspension, or no additional lower eyelid procedure. The specific surgical techniques, including suture placement, tissue fixation, suture material, tension, and periosteal fixation, will be standardized across participants within each intervention group. All surgical procedures will be performed by the same surgeon across all three study groups to ensure consistency of the surgical technique and minimize operator-related variability.
Postoperative Management: All participants in the three study groups will receive standardized postoperative management, including Frost suture, eyelid taping, eyelid massage, corticosteroid therapy, and postoperative dressing. The same postoperative management protocol will be applied to all treatment groups to ensure consistency of postoperative care.
Before randomization and surgery, all participants will undergo a standardized preoperative assessment of the lower eyelid and lateral canthal position. The assessment will include measurement of baseline margin reflex distance 2 (MRD2), evaluation of scleral show, lower eyelid position, canthal tilt, and lateral canthal position. Standardized clinical assessment of lower eyelid laxity will also be performed using the snap-back test and eyelid distraction test. Standardized preoperative photographs will be obtained using consistent patient positioning and standardized views to document baseline eyelid and lateral canthal anatomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned in a parallel design to one of three intervention groups: subciliary approach alone, subciliary approach with lateral canthopexy, or subciliary approach with orbicularis oculi suspension. Outcomes will be compared between the groups during scheduled postoperative follow-up.
| Arm | Type | Receives |
|---|---|---|
| Subciliary Approach | Active comparator | Procedure: Subciliary ApproachParticipants will undergo orbital fracture repair using the subciliary approach. |
| Subciliary Approach with Lateral Canthopexy | Experimental | Procedure: Subciliary Approach, Procedure: Lateral CanthopexyParticipants will undergo orbital fracture repair using the subciliary approach combined with lateral canthopexy. The effect of lateral canthopexy on postoperative lower eyelid position and the incidence of ectropion will be evaluated. |
| Subciliary Approach with Orbicularis Oculi Suspension | Experimental | Procedure: Subciliary Approach, Procedure: Orbicularis Oculi SuspensionParticipants will undergo orbital fracture repair using the subciliary approach combined with orbicularis oculi suspension. The effect of orbicularis oculi suspension on postoperative lower eyelid position and the incidence of ectropion will be evaluated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Systemically healthy patients aged 18 years or older, with no history of chronic or uncontrolled systemic diseases.
- Patients with primary orbital trauma requiring surgical treatment through a standardized subciliary approach, presenting with orbital floor fractures with or without associated lateral orbital rim fractures involving the lateral canthal tendon region, and without associated zygomaticomaxillary complex (ZMC) fractures.
Key exclusion criteria (5 listed)
- Secondary orbital trauma (revision cases or patients with previous orbital trauma).
- Previous lower eyelid surgery.
- Pre-existing eyelid malposition (ectropion or entropion) or other pre-existing lower eyelid or lateral canthal abnormalities.
- Uncontrolled systemic conditions that may affect wound healing, eyelid integrity, or lower eyelid laxity, including uncontrolled diabetes mellitus, immunocompromised status, chronic corticosteroid therapy, or collagen vascular diseases.
- Previous radiotherapy to the orbital or facial region.
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 |
|---|---|---|
| Subciliary ApproachStandardized subciliary approach for orbital fracture repair. The skin incision will be placed approximately 2 mm below the lower eyelid margin within a natural skin crease, extending from approximately 1 mm temporal to the inferior punctum toward the lateral canthal region. A stepped skin-muscle approach will be used, with the skin incision followed by inferior subcutaneous dissection and subsequent incision of the preseptal orbicularis oculi muscle approximately 7 mm inferior to the subciliary margin. Dissection will proceed to the infraorbital rim while maintaining the integrity of the orbital septum. The periosteum will be incised approximately 3-4 mm below the inferior orbital rim on its facial aspect to obtain surgical exposure. | Procedure or surgery | Subciliary Approach, Subciliary Approach with Lateral Canthopexy, Subciliary Approach with Orbicularis Oculi Suspension |
| Lateral CanthopexyLateral Canthopexy Technique: A 4-0 polydioxanone (PDS) suture on a P2 needle will be placed through the periosteum of the inner aspect of the lateral orbital rim over Whitnall's tubercle at the desired height. The suture will then engage the medial end of the lateral canthal tendon and the lateral border of the lower eyelid tarsus in a vertical direction. The suture will be tied with the lower eyelid positioned at the desired height. Periosteal fixation will be used. | Procedure or surgery | Subciliary Approach with Lateral Canthopexy |
| Orbicularis Oculi SuspensionA standardized orbicularis oculi suspension procedure performed in conjunction with the subciliary approach. Following the subciliary incision, the orbicularis oculi muscle is split 7 mm inferior to the subciliary margin while preserving pretarsal muscle function. The lateral edge of the preseptal orbicularis oculi muscle is bluntly dissected to the lateral orbital rim and suspended to the periosteum at the anchoring point using a Vicryl 5-0 or 6-0 horizontal mattress suture with appropriate tension. | Procedure or surgery | Subciliary Approach with Orbicularis Oculi Suspension |
Primary outcome
Incidence of postoperative lower eyelid ectropion
Time frame: 1 week, 1 month, 3 months, and 6 months postoperatively
The proportion of participants who develop postoperative lower eyelid ectropion after orbital fracture repair. Ectropion will be assessed clinically by an examiner blinded to treatment allocation using the Ectropion Grading Scale (EGS), a standardized grading system for assessing the severity of lower eyelid ectropion. The severity will be graded from Grade 0 (normal eyelid position) to Grade V (severe ectropion with associated complications). Standardized postoperative photographs will also be obtained using consistent patient positioning and standardized views at each assessment time point to facilitate comparison of postoperative lower eyelid position and ectropion severity over time.
6 secondary outcomes
Change in lower margin reflex distance 2 (MRD2) from baseline
Time frame: 1 week, 1 month, 3 months, and 6 months postoperatively
Inferior scleral show
Time frame: 1 week, 1 month, 3 months, and 6 months postoperatively
Postoperative lower eyelid retraction
Time frame: 1 week, 1 month, 3 months, and 6 months postoperatively
Ectropion severity
Time frame: 1 week, 1 month, 3 months, and 6 months postoperatively
Subciliary scar assessment
Time frame: 1 month, 3 months, and 6 months postoperatively
Patient satisfaction
Time frame: 1 month, 3 months, and 6 months postoperatively
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 20 Aug 2026.
- Background: PubMed 30337055Al-Moraissi E, Elsharkawy A, Al-Tairi N, Farhan A, Abotaleb B, Alsharaee Y, Oginni FO, Al-Zabidi A. What surgical approach has the lowest risk of the lower lid complications in the treatment of orbital floor and periorbital fractures? A frequentist network meta-analysis. J Craniomaxillofac Surg. 2018 Dec;46(12):2164-2175. doi: 10.1016/j.jcms.2018.09.001. Epub 2018 Sep 21.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to confidentiality and institutional ethical requirements.
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
Recruiting
Clinical Outcomes of Transconjunctival Vs Transcutaneous Approaches in Orbital Fracture Repair
Orbital 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.
Hamed Gad, PhD principal investigator
Faculty of Dentistry, Minia University
Alaa Othman, PhD study director
Samalout Specialized Hospital
Mohamed S. Elkhouly, PhD study director
Faculty of Dentistry, Minia University
Questions about this trial
What is this clinical trial studying?
A study testing Subciliary Approach, Lateral Canthopexy and Orbicularis Oculi Suspension in people with Orbital Fractures and Orbital Floor Fractures, run by Minia 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 2 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 20 Aug 2026. 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 Yasmin Abdelfattah, BDS (+20 1116104101, yasmin.a7med16@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative lower eyelid ectropion (time frame: 1 week, 1 month, 3 months, and 6 months postoperatively). 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 NCT07775417, which also lists 1 linked publication.
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 Aug 2026.