Structural Orbital Changes in Anophthalmic Socket Syndrome

Understand better the aetiology and physiopathogenesis of anophthalmic socket syndrome.

Completed

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Key information

Conditions

Anophthalmos; Acquired Anophthalmic Socket Syndrome Anophthalmos Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Abnormalities Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Diagnostic Test

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.

Primary outcomes

Displacement of orbital structures

Time frame: At least 5 years after enucleation or evisceration

mm in x,y,z axis
Volumetric orbital difference

Time frame: At least 5 years after enucleation or evisceration

ml
Surface comparisson of bony orbits

Time frame: At least 5 years after enucleation or evisceration

mm

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2023
First posted: May 20, 2020
Registry last updated: Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed