Structural Orbital Changes in Anophthalmic Socket Syndrome

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04395404

Enrollment

Registered

2020-05-20

Start date

2020-07-01

Completion date

2023-02-28

Last updated

2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anophthalmic Socket Syndrome, Anophthalmos; Acquired

Brief summary

Understand better the aetiology and physiopathogenesis of anophthalmic socket syndrome.

Interventions

DIAGNOSTIC_TESTMRI

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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
Surface comparisson of bony orbits	At least 5 years after enucleation or evisceration	mm

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026