A Trial to Evaluate Two Ectropion Preventive Measures Using the Subciliary Approach in Orbital Fracture Surgery. (PREVENTECT)
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:
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yasmin Abdelfattah, BDS
- Phone Number: +20 1116104101
- Email: yasmin.a7med16@yahoo.com
Study Contact Backup
- Name: Mohamed S. Elkhouly, PhD
- Phone Number: +20 1002318399
- Email: mohammed.s.elkhouly@minia.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Subciliary Approach
Participants will undergo orbital fracture repair using the subciliary approach.
|
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.
|
|
Experimental: Subciliary Approach with Lateral Canthopexy
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.
|
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 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.
|
|
Experimental: Subciliary Approach with Orbicularis Oculi Suspension
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 week, 1 month, 3 months, and 6 months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in lower margin reflex distance 2 (MRD2) from baseline
Time Frame: 1 week, 1 month, 3 months, and 6 months postoperatively
|
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.
|
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
|
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.
|
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
|
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.
|
1 week, 1 month, 3 months, and 6 months postoperatively
|
|
Ectropion severity
Time Frame: 1 week, 1 month, 3 months, and 6 months postoperatively
|
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.
|
1 week, 1 month, 3 months, and 6 months postoperatively
|
|
Subciliary scar assessment
Time Frame: 1 month, 3 months, and 6 months postoperatively
|
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.
|
1 month, 3 months, and 6 months postoperatively
|
|
Patient satisfaction
Time Frame: 1 month, 3 months, and 6 months postoperatively
|
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.
|
1 month, 3 months, and 6 months postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hamed Gad, PhD, Faculty of Dentistry, Minia University
- Study Director: Alaa Othman, PhD, Samalout Specialized Hospital
- Study Director: Mohamed S. Elkhouly, PhD, Faculty of Dentistry, Minia University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OMFS-ECT-2026-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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