Structural Orbital Changes in Anophthalmic Socket Syndrome

Anophthalmos; Acquired Clinical Trial

Official title:

Structural Orbital Changes in Anophthalmic Socket Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04395404
• Other study ID #: s62697
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 2020

Study information

• Verified date: November 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Sébastien Ruiters, MD
• Phone: +32 16 33 23 70
• Email: sebastien.ruiters[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Understand better the aetiology and physiopathogenesis of anophthalmic socket syndrome.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Anophthalmic Socket Syndrome
• Anophthalmos
• Anophthalmos; Acquired
• Syndrome

Intervention

Diagnostic Test:
• MRI
Patients with unilateral ASS, with and without the prosthesis in situ, are analysed by 3D- magnetic resonance imaging (MRI) with 64 channel head coil using T1 and T2 weighted, DIXON/ IDEAL, and T2 inversion recovery sequences.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

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