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

Summary

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.

Conditions

• Orbital Fractures
• Orbital Floor Fractures

Interventions

PROCEDURE

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.

PROCEDURE

Lateral Canthopexy

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.

PROCEDURE

Orbicularis Oculi Suspension

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.

Sponsors & Collaborators

• Minia University

  lead OTHER

Principal Investigators

• Hamed Gad, PhD · Faculty of Dentistry, Minia University

• Alaa Othman, PhD · Samalout Specialized Hospital

• Mohamed S. Elkhouly, PhD · Faculty of Dentistry, Minia University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2027-10-31

Completion

2027-11-30