A Trial to Evaluate Two Ectropion Preventive Measures Using the Subciliary Approach in Orbital Fracture Surgery.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMinia University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Subciliary Approach
Procedure/SurgeryStandardized 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
Procedure/SurgeryLateral 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 Suspension
Procedure/SurgeryA 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.
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Subciliary ApproachActive comparator 1 intervention
Group B: Subciliary Approach with Lateral CanthopexyExperimental treatment 2 interventions
Group C: Subciliary Approach with Orbicularis Oculi SuspensionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
1 week, 1 month, 3 months, and 6 months postoperativelySecondary outcomes
1
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.
Time frame
1 week, 1 month, 3 months, and 6 months postoperatively2
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.
Time frame
1 week, 1 month, 3 months, and 6 months postoperatively3
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.
Time frame
1 week, 1 month, 3 months, and 6 months postoperatively4
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.
Time frame
1 week, 1 month, 3 months, and 6 months postoperativelyLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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