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
Qualifiers
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
Treatments tested in this trial
- Subciliary Approach
- Lateral Canthopexy
- Orbicularis Oculi Suspension
Treatment groups
30 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov