Structural Orbital Changes in Anophthalmic Socket Syndrome

Not Applicable

Completed

• Conditions: Anophthalmic Socket Syndrome; Anophthalmos; Acquired
• Interventions: Diagnostic Test: MRI

• Registration Number: NCT04395404
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

Understand better the aetiology and physiopathogenesis of anophthalmic socket syndrome.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-14
• Study First Posted: 2020-05-20
• Study Start: 2020-07-01
• Primary Completion: 2020-11-01
• Study Completion: 2023-02-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	MRI	-

Primary Outcome Measures

Name	Time	Method
Surface comparisson of bony orbits	At least 5 years after enucleation or evisceration	mm
Displacement of orbital structures	At least 5 years after enucleation or evisceration	mm in x,y,z axis
Volumetric orbital difference	At least 5 years after enucleation or evisceration	ml

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium