Structural Orbital Changes in Anophthalmic Socket Syndrome

July 2, 2024 updated by: Universitaire Ziekenhuizen KU Leuven
Understand better the aetiology and physiopathogenesis of anophthalmic socket syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Displacement of orbital structures
Time Frame: At least 5 years after enucleation or evisceration
mm in x,y,z axis
At least 5 years after enucleation or evisceration
Volumetric orbital difference
Time Frame: At least 5 years after enucleation or evisceration
ml
At least 5 years after enucleation or evisceration
Surface comparisson of bony orbits
Time Frame: At least 5 years after enucleation or evisceration
mm
At least 5 years after enucleation or evisceration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

November 1, 2020

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

May 11, 2020

First Submitted That Met QC Criteria

May 14, 2020

First Posted (Actual)

May 20, 2020

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

July 2, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s62697

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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