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The Application of Automatic Surgical Reconstruction System in Surgical Repair for Orbital Blow-out Fracture

The Application of Automatic Surgical Reconstruction System in Surgical Repair for Orbital Blow-out Fracture

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083193
Enrollment
Unknown
Registered
2024-04-17
Start date
2023-08-09
Completion date
Unknown
Last updated
2024-04-22

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

Conditions

orbital blow-out fracture

Interventions

experimental group:Application of automatic reconstruction system in surgical repair for orbital blow-out fracture

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Age of 6-65; 2) Diagnosis of unilateral orbital blow-out fracture; 3) Indication for surgical repair: ? Enophthalmos or eyeball displacement of at least 2mm; ? Persistent diplopia; ? Incarceration or protrusion of orbital soft tissue and/ or extraocular muscles showed on CT scan. Surgical repair is indicated if any of the condition is satisfied. 4) Volunteer to participate in the trial, understand the treatment plan and sign an informed consent form, are willing to comply with postoperative management procedures, cooperate with clinical trial plans, and complete postoperative follow-up.

Exclusion criteria

Exclusion criteria: 1) Surgical history of orbital fracture; 2) Patients with ophthalmorrhexis; 3) Patients with other diseases that may cause enophthalmos or diplopia; 4) Patients with surgical contraindications.

Design outcomes

Primary

MeasureTime frame
The effective rate of correcting or preventing enophthalmos after 6 months of surgery;

Secondary

MeasureTime frame
visual acuity, enophthalmos, ocular movement, double vision condition;preparation time of materials;operative time;

Countries

China

Contacts

Public ContactHuifang Zhou

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

fangzzfang@sjtu.edu.cn+86 136 6190 1886

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026