- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04395404
Structural Orbital Changes in Anophthalmic Socket Syndrome
November 3, 2020 updated by: Universitaire Ziekenhuizen KU Leuven
Understand better the aetiology and physiopathogenesis of anophthalmic socket syndrome.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
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 Contact
- Name: Sébastien Ruiters, MD
- Phone Number: +32 16 33 23 70
- Email: sebastien.ruiters@uzleuven.be
Study Locations
-
-
-
Leuven, Belgium, 3000
- Recruiting
- UZ Leuven
-
Contact:
- Sébastien Ruiters
- Phone Number: +32 16 33 23 70
- Email: sebastien.ruiters@uzleuven.be
-
-
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
Genders Eligible for Study
All
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
|
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.
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 (Anticipated)
December 1, 2020
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)
November 4, 2020
Last Update Submitted That Met QC Criteria
November 3, 2020
Last Verified
November 1, 2020
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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