Anophthalmos; AcquiredNCT04395404
Structural Orbital Changes in Anophthalmic Socket Syndrome
A study testing MRI in people with Anophthalmos; Acquired and Anophthalmic Socket Syndrome, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Understand better the aetiology and physiopathogenesis of anophthalmic socket syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anophthalmos; Acquired, Anophthalmic Socket Syndrome
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2020to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Understand better the aetiology and physiopathogenesis of anophthalmic socket syndrome.
- Being tested
- MRI
- Medical subject headings
- Anophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
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 group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Not described Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Displacement of orbital structures
mm in x,y,z axis
Measured: At least 5 years after enucleation or evisceration
Volumetric orbital difference
ml
Measured: At least 5 years after enucleation or evisceration
Surface comparisson of bony orbits
mm
Measured: At least 5 years after enucleation or evisceration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start1 Jul 2020
- Primary completion1 Nov 2020
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anophthalmos; AcquiredStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395404
- Sponsor's protocol ID
- s62697
- Status last verified
- Jul 2024
- First submitted
- 11 May 2020
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural Orbital Changes in Anophthalmic Socket Syndrome
- ClinicalTrials.gov ID
- NCT04395404
- Acronym / sponsor ID
- s62697
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 20 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Understand better the aetiology and physiopathogenesis of anophthalmic socket syndrome.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Diagnostic Test: MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIPatients 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. | Diagnostic test | Single arm |
Primary outcome
Displacement of orbital structures
Time frame: At least 5 years after enucleation or evisceration
mm in x,y,z axis
Volumetric orbital difference
Time frame: At least 5 years after enucleation or evisceration
ml
Surface comparisson of bony orbits
Time frame: At least 5 years after enucleation or evisceration
mm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Anophthalmos; Acquired and Anophthalmic Socket Syndrome, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Displacement of orbital structures (time frame: At least 5 years after enucleation or evisceration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.