PREVENTECT
A Comparative Clinical Trial Evaluating Preventive Techniques for Postoperative Ectropion Following the Subciliary Approach in Orbital Trauma.
Sponsor study identifier
interventional
30
0 countries
N/A
Study Start
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 7, 2026
Actual (reported)August 20, 2026
Actual (reported)September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
1 week, 1 month, 3 months, and 6 months postoperatively
Change in lower margin reflex distance 2 (MRD2) from baseline
1 week, 1 month, 3 months, and 6 months postoperatively
Participants will undergo orbital fracture repair using the subciliary approach.
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.
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.
Hamed Gad, PhD
Faculty of Dentistry, Minia University
Alaa Othman, PhD
Samalout Specialized Hospital
Mohamed S. Elkhouly, PhD
Faculty of Dentistry, Minia University
First Submitted
August 7, 2026
First Posted
August 20, 2026
Study Start
September 1, 2026
Estimated (date passed)Using the Transconjuctival Approach Alone Versus Using it Together With Lateral Canthotomy in Orbital Fractures
Inferior scleral show
1 week, 1 month, 3 months, and 6 months postoperatively
Postoperative lower eyelid retraction
1 week, 1 month, 3 months, and 6 months postoperatively
Ectropion severity
1 week, 1 month, 3 months, and 6 months postoperatively
Subciliary scar assessment
1 month, 3 months, and 6 months postoperatively
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.
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.
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.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 20, 2026
Record last verified: 2026-08
Individual participant data will not be shared due to confidentiality and institutional ethical requirements.
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