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RecruitingNCT07759440Vs: versusUpdated Aug 12, 2026

Clinical Outcomes of Transconjunctival Vs Transcutaneous Approaches in Orbital Fracture Repair

An interventional study of orbital fracture reduction and fixation in Orbital Fractures, sponsored by Alexandria University. Recruiting at 1 site in Egypt. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Alexandria University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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

02

Conditions studied

  • Orbital Fractures

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03

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

    • 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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
75 participants (estimated)

Study arms

  • Active comparator
    subtarsal approach

    Other: orbital fracture reduction and fixation

  • Active comparator
    infraorbital approach

    Other: orbital fracture reduction and fixation

  • Active comparator
    transconjunctival approach

    Other: orbital fracture reduction and fixation

Interventions

  • Otherorbital fracture reduction and fixation

    orbital fracture reduction and fixation

05

What researchers measure

Primary outcomes

  1. operation time

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

    Time frame: intraopertive in minutes

  2. accessibility

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

    Time frame: intraopertive

Secondary outcomes

  1. wound healing 1

    by Manchester scar scale

    Time frame: 1, 2 and 8 weeks

06

Study locations

1 of 1 sites recruiting
  • Alexandria university
    Alexandria, Outside US and Canada 2881055, Egypt
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07759440
Lead sponsor
Alexandria University
Responsible party
mona oraby (lecturer, Alexandria University) — Principal investigator
First posted
Aug 12, 2026
Start date
May 25, 2026
Primary completion
Nov 25, 2026 (estimated)
Completion
Nov 25, 2026 (estimated)
Last update
Aug 12, 2026

Study contacts

Mona s Oraby, PHd
Contact
mona.oraby@alexu.edu.eg
+201000775330

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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