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Investigation of 3D-printed bone implants in surgeries of eye orbit lesions

The Fabrication and clinical assessment of 3D-printed personalized bone implants for the treatment of eye orbit lesions

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220807055633N3
Enrollment
500
Registered
2024-06-03
Start date
2024-02-21
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Resorbable bone implants for repair of eye orbit lesions. Presence of other bone and tendon implants

Interventions

For individuals suffering from bone defects in the orbital region of the eye, customized 3D printed implants composed of polycaprolactone and hydroxyapatite (40% wt) are employed in the surgical proce

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with bone lesions in the eye orbit

Exclusion criteria

Exclusion criteria: Patients with a history of undergoing cancer therapy Patients with a history of diabetes Patients with a history of osteoporosis Patients with a history of cigarette use Patients with challenges with anesthesia administration Patients with susceptibility to antibiotics

Design outcomes

Primary

MeasureTime frame
Newly formed bone density after implant placement. Timepoint: 1 year after implant placement in the body. Method of measurement: Providing CT scan images.;The rate of new bone formation. Timepoint: 1 to 2 years after implant placement in the body. Method of measurement: Providing CT scan images and analyzing with Mimics software.

Secondary

MeasureTime frame
Biodegradation rate of the implant. Timepoint: 1 year after implant placement in the body. Method of measurement: Providing CT scan images.;Orbital region and eyes contouring. Timepoint: 6 months to 1 year after implant placement in the body. Method of measurement: Clinical observation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Ali Poursamar

Esfahan University of Medical Sciences

ali.poursamar@amt.mui.ac.ir+98 31 3792 3865

Outcome results

None listed

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