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Structural Orbital Changes in Anophthalmic Socket Syndrome

Primary Purpose

Anophthalmos; Acquired, Anophthalmic Socket Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
MRI
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anophthalmos; Acquired

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • UZ LeuvenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

Outcomes

Primary Outcome Measures

Displacement of orbital structures
mm in x,y,z axis
Volumetric orbital difference
ml
Surface comparisson of bony orbits
mm

Secondary Outcome Measures

Full Information

First Posted
May 11, 2020
Last Updated
November 3, 2020
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT04395404
Brief Title
Structural Orbital Changes in Anophthalmic Socket Syndrome
Official Title
Structural Orbital Changes in Anophthalmic Socket Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Understand better the aetiology and physiopathogenesis of anophthalmic socket syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anophthalmos; Acquired, Anophthalmic Socket Syndrome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI
Intervention Description
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 Outcome Measure Information:
Title
Displacement of orbital structures
Description
mm in x,y,z axis
Time Frame
At least 5 years after enucleation or evisceration
Title
Volumetric orbital difference
Description
ml
Time Frame
At least 5 years after enucleation or evisceration
Title
Surface comparisson of bony orbits
Description
mm
Time Frame
At least 5 years after enucleation or evisceration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sébastien Ruiters, MD
Phone
+32 16 33 23 70
Email
sebastien.ruiters@uzleuven.be
Facility Information:
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien Ruiters
Phone
+32 16 33 23 70
Email
sebastien.ruiters@uzleuven.be

12. IPD Sharing Statement

Plan to Share IPD
No

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Structural Orbital Changes in Anophthalmic Socket Syndrome

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