Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:30 PM
Ignite Modification Date:
2025-12-24 @ 2:30 PM
NCT ID:
NCT01121159
Eligibility Criteria:
Inclusion Criteria:
1. Patients ≥ 18 years
2. Fracture (not older than 14 days) of the medial orbital wall and/or the orbital floor
3. Scheduled for reconstruction surgery with one of the following implants:
* MatrixMIDFACE Preformed Orbital Plate
* Custom-made orbital implant
* Orbital Floor Mesh Plate
* SynPOR Titanium Reinforced Fan Sheet
4. At least partial sight in both eyes before the accident
5. Willingness and ability to participate in the study follow-up according to the protocol
6. Ability to understand and read local language at elementary level
7. Signed informed consent
Exclusion Criteria:
1. Bilateral orbital fracture
2. Fractures of the orbital roof
3. Comminuted zygoma fracture
4. More than one piece fracture of the intraorbital bone lateral to the inferior orbital fissure
5. Previous dislocated orbital fractures on either side
6. Vision or diplopia not assessable
7. Injury of the globe
8. Neurological diseases with influence on eye motility or sight
9. Legal incompetence
10. Active malignancy
11. Life-threatening condition
12. Alcohol and drug abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01121159
Study Brief:
Protocol Section:
NCT01121159