Clinical Outcomes of Transconjunctival Vs Transcutaneous Approaches in Orbital Fracture Repair

NCT07759440 | Recruiting

• 1 other identifier: IRB No. 00010556- IORG 0008839
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Open reduction and internal fixation of zygomaticomaxillary complex (ZMC) fractures has a challenging impact on the selection of the suitable surgical approach to the orbital and zygomatic skeleton. Precise repair of the ZMC fractures needs a quite understanding of the regional anatomy, precise diagnosis, an accessible exposure, and an accurate rigid fixation of fracture to restore the normal form. The aesthetic results are one of the most important requirements for these incisions in facial fracture reduction. Conventional approaches to the infraorbital rim/orbital floor include transcutaneous as subciliary, subtarsal and infraorbital incisions and transconjunctival incision. A thorough understanding of each incisional technique requires an appreciation of the relevant anatomy putting in considerations the risk of associated complications. Aim of this study:To compare between transconjunctival approach and transcutaneous approaches in open reduction of zygomaticomaxillary fracture. Materials and methods: A study will be made on 75 patients who will undergo fracture repair of the zygomaticomaxillary complex. Twenty five of them (group A) will be treated via a subtarsal approach while. Other Twenty five patients (group B) via a transconjunctival approach. The remaining Twenty five patients (Group C) will be treated via infraorbital appeoach. Postoperative patient evaluation will be performed with specific attention paid towards, accessibility, the exposure duration (time from incision till exposure of the field), esthetic appearance ,postoperative pain, postoperative edema , wound healing, scaring, infection and postoperative ocular complications such as ectropion, entropion, scleral show and corneal abrasion. Postoperatively clinical examination along with radiographic examination will be done to evaluate the position of the zygoma and determine the adequacy of fracture reduction. Results: will be statistically analyzed using the IBM Statistical Package for Social Science (SPSS) software version 22.0

Conditions

Orbital Fractures

Outcome Measures

Primary Outcomes (2)

• operation time

  starting from the skin incision till the reduction and fixation of the orbital rim

  intraopertive in minutes

• accessibility

  objective assessment by the main surgeon ( mild, moderate, excellent) accessibility

  intraopertive

Secondary Outcomes (1)

• wound healing 1

  1, 2 and 8 weeks

Study Arms (3)

subtarsal approach

ACTIVE COMPARATOR

Other: orbital fracture reduction and fixation

infraorbital approach

ACTIVE COMPARATOR

Other: orbital fracture reduction and fixation

transconjunctival approach

ACTIVE COMPARATOR

Other: orbital fracture reduction and fixation

Interventions

orbital fracture reduction and fixation OTHER

orbital fracture reduction and fixation

infraorbital approach; subtarsal approach; transconjunctival approach

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient with orbital fractures (e.g., orbital floor or zygomaticomaxillary complex fractures) require open reduction with internal fixation.
• Adult patient between 20 and 50 years with no gender predilections.

You may not qualify if:

• Existing lacerations in the inferior and lateral periorbital regions.
• Comminuted fracture with bone loss.
• Existence of infection at the fracture line.
• Presence of acute or chronic conjunctival diseases.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria university

Alexandria, Outside US and Canada, 2881055, Egypt

RECRUITING

MeSH Terms

Conditions

Orbital Fractures

Condition Hierarchy (Ancestors)

Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Central Study Contacts

Mona s Oraby, PHd

CONTACT

+201000775330; mona.oraby@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 12, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): November 25, 2026
• Study Completion (Estimated): November 25, 2026
• Last Updated: August 12, 2026

Record last verified: 2026-08

Locations

EG (1)