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Status unknownNCT04271137Updated Feb 17, 2020

Correction of Enophthalmos and Orbital Volume Using Pre-bent Mesh Versus 3d Printed Onlay in Orbital Fracture Cases

An interventional study of 3D printed PEEK onlay and Pre-bent orbital mesh in Orbital Fractures, Enophthalmos and Periorbital Fracture, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 17 Years and older. Per ClinicalTrials.gov, last updated 2020-02-17.

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

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
17 Years and older
Sex
All
01

Study summary

this study evaluates the post-surgical correction of enophthalmos and orbital volume using 3D printed only versus pre-bent titanium mesh in blow-out fracture cases

Read the detailed description

Many materials had been used in reconstruction of blow out fractures, the aim of this study is to evaluate the enophthalmos correction and orbital volume restoration using 3D printed onlay versus pre-bent titanium mesh

02

Conditions studied

  • Orbital Fractures
  • Enophthalmos
  • Periorbital Fracture

Keywords

  • 3d printed onlay
  • PEEK
  • orbital mesh
  • computer-guided surgery
03

In context

Orbital Fractures

25 studies on the registry are indexed under Orbital Fractures; 5 are open to participants now.

This study's planned enrollment of 20 is below the median of 25 across 16 interventional studies indexed under Orbital Fractures.

Browse Orbital Fractures studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patients (≤17 years old).
  • Blow-out Orbital Fracture.
  • Unilateral Orbital Trauma.
  • Enophthalmos (≤ 2 mm).
  • Patients with contralateral healthy, non-surgically operated orbit.

Exclusion criteria

Exclusion Criteria:

  • Young Patients (> 17 years old).
  • Patients with Systemic diseases.
  • Bilateral Orbital Trauma.
  • Enophthalmos (>2 mm).
  • Patients whom cannot tolerate follow up intervals.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    Orbital fractues

    Orbital fractures

    Combination Product: 3D printed PEEK onlay · Combination Product: Pre-bent orbital mesh

Interventions

  • Combination product3D printed PEEK onlay

    3d computer-designed Orbital onlay

  • Combination productPre-bent orbital mesh

    Pre-bent orbital mesh on 3d printed template

06

What researchers measure

Primary outcomes

  1. Enophthalmos

    CT based exphthalmometery - corneal projection from lateral orbital rim measured in millimeters

    Time frame: 1 week post-operative

  2. Enophthalmos

    CT based - corneal projection from lateral orbital rim measured in millimeters

    Time frame: 1 year post-operative

Secondary outcomes

  1. Orbital volume

    Change in orbital volume ratio on CT in centimeter cubic

    Time frame: one week post-operative

  2. Implant position accuracy

    Superimposition of pre- and post-operative 3d bony structures on CT in 2d views of the x-ray

    Time frame: One week post-operative

07

Study locations

1 site
  • Faculty of Dentistry - Cairo University
    Cairo, 11553, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04271137
Lead sponsor
Cairo University
Responsible party
Mohamed Salah (Principal investigator, Cairo University) — Principal investigator
First posted
Feb 17, 2020
Start date
Mar 1, 2020 (estimated)
Primary completion
Jan 1, 2021 (estimated)
Completion
Mar 1, 2021 (estimated)
Last update
Feb 17, 2020

Study contacts

Khalid Amr, PhD
Contact
khaledamr82@gmail.com
+201006029031
Ahmed Mohamed, PhD
study director · Cairo University

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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