Anophthalmos; Acquired Clinical Trial
Official title:
Structural Orbital Changes in Anophthalmic Socket Syndrome
NCT number | NCT04395404 |
Other study ID # | s62697 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2020 |
Est. completion date | December 2020 |
Understand better the aetiology and physiopathogenesis of anophthalmic socket syndrome.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | December 2020 |
Est. primary completion date | November 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age 18 years or older - Unilateral anophthalmic socket syndrome (superior sulcus grading 0 till 4) - Enucleation/evisceration with primary implant more than 5 years ago - After informed consent Exclusion Criteria: - MRI absolute and relative contraindications such as metallic fragments or metallic containing devices, - history of orbital trauma, previous anophthalmic socket and eyelid surgery, inflammation, infection, buphthalmos, congenital anophthalmos and radiation |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Leuven | Leuven |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Displacement of orbital structures | mm in x,y,z axis | At least 5 years after enucleation or evisceration | |
Primary | Volumetric orbital difference | ml | At least 5 years after enucleation or evisceration | |
Primary | Surface comparisson of bony orbits | mm | At least 5 years after enucleation or evisceration |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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