A Trial to Evaluate Two Ectropion Preventive Measures Using the Subciliary Approach in Orbital Fracture Surgery. (PREVENTECT)

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.