Structural Orbital Changes in Anophthalmic Socket Syndrome

• Sponsor: Universitaire Ziekenhuizen Leuven (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04395404
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

Understand better the aetiology and physiopathogenesis of anophthalmic socket syndrome.

Condition or Disease	Intervention/Treatment	Phase
Anophthalmos; Acquired; Anophthalmic Socket Syndrome	Diagnostic Test: MRI	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Structural Orbital Changes in Anophthalmic Socket Syndrome
• Actual Study Start Date: Jul 1, 2020
• Actual Primary Completion Date: Nov 1, 2020
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single arm	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.

Outcome Measures

Primary Outcome Measures

1. Displacement of orbital structures [At least 5 years after enucleation or evisceration]

   mm in x,y,z axis

2. Volumetric orbital difference [At least 5 years after enucleation or evisceration]

   ml

3. Surface comparisson of bony orbits [At least 5 years after enucleation or evisceration]

   mm

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Leuven	Leuven		Belgium	3000

Sponsors and Collaborators

• Universitaire Ziekenhuizen Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universitaire Ziekenhuizen Leuven
• ClinicalTrials.gov Identifier: NCT04395404
• Other Study ID Numbers: s62697
• First Posted: May 20, 2020
• Last Update Posted: Nov 4, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anophthalmos; Syndrome

Study Results

No Results Posted as of Nov 4, 2020