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Comparative study between orbital fixation by traditional orbital floor mesh vs prefabricated orbital floor mesh in patients with traumatic blow-out orbital floor fracture

Comparative study between orbital fixation by traditional orbital floor mesh vs prefabricated orbital floor mesh in patients with traumatic blow-out orbital floor fracture

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202511716450422
Enrollment
40
Registered
2025-11-21
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Diseases Injury, Occupational Diseases, Poisoning

Interventions

Traditional manually contoured titanium orbital floor mesh
Prefabricated precontoured titanium orbital floor mesh

Sponsors

Assiut University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients aged 18 years and above Diagnosed with isolated, unilateral traumatic blow-out orbital floor fracture confirmed by clinical and radiological (CT) assessment Indicated for surgical repair (enophthalmos >2 mm, persistent diplopia, orbital floor defect >50% or >2 cm²) Presenting within 2 weeks of injury Willing and able to provide informed consent and comply with follow-up visits

Exclusion criteria

Exclusion criteria: Bilateral orbital floor fractures Associated complex midface fractures requiring other reconstructive procedures Previous orbital surgery on the affected side Pre-existing ocular motility disorders or vision loss unrelated to trauma Severe systemic illness or contraindications to surgery

Design outcomes

Primary

MeasureTime frame
Accuracy of anatomical restoration, measured by comparing postoperative orbital volume (using CT-based 3D reconstruction) to the contralateral normal orbit, and assessment of correction of enophthalmos and diplopia.

Secondary

MeasureTime frame
Surgical time (from incision to closure);Intraoperative and postoperative complications (e.g., infection, implant malposition, extrusion, persistent diplopia, infraorbital nerve dysfunction);Patient-reported satisfaction with cosmetic and functional results;Need for revision surgery

Countries

Egypt

Contacts

Public ContactMustafa Abd Elaziz

Assiut University

Alaa.eldin.amostafa@aun.edu.eg+201224776012

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026