Orbital InflammationRetroG4NCT02900859
Infraorbital Nerve Involvement on Magnetic Resonance Imaging in European Patients With IgG4-related Ophthalmic Disease
An observational study of Orbital Inflammation, run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial summary
Systematic medical chart and imaging files review of patients presenting with non-lymphoma, non-thyroid-related orbital inflammation. The review aims at comparing the frequency of MRI infra-orbital nerve enlargement, between patients diagnosed with an IgG4-related ophthalmic disease (IgG4-ROD) and other patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orbital Inflammation
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Apr 2015
- Phase
- Observational
- 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
Study population: Patients suffering from non-lymphoma, non-thyroid-related orbital inflammation
Who may be able to join
- Patient suffering from acute orbital inflammation
Who cannot join
- Thyroid disease
- Lymphoma
About this study
Systematic medical chart and imaging files review of patients presenting with non-lymphoma, non-thyroid-related orbital inflammation. The review aims at comparing the frequency of MRI infra-orbital nerve enlargement, between patients diagnosed with an IgG4-related ophthalmic disease (IgG4-ROD) and other patients.
- Conditions
- Orbital Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Infra-orbital nerve enlargement on orbital MRI
Measured: Within 1 week following diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startJan 2006
- Primary completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orbital InflammationStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900859
- Sponsor's protocol ID
- NI_ALR_2015_2
- Acronym
- RetroG4
- Status last verified
- Sep 2016
- First submitted
- 6 Sep 2016
- Last updated
- 14 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infraorbital Nerve Involvement on Magnetic Resonance Imaging in European Patients With IgG4-related Ophthalmic Disease
- ClinicalTrials.gov ID
- NCT02900859
- Acronym / sponsor ID
- RetroG4 / NI_ALR_2015_2
- Conditions
- Orbital Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Jan 2006
- Primary completion
- Apr 2015 (actual)
- First posted
- 14 Sep 2016 (estimated)
- 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.
Systematic medical chart and imaging files review of patients presenting with non-lymphoma, non-thyroid-related orbital inflammation. The review aims at comparing the frequency of MRI infra-orbital nerve enlargement, between patients diagnosed with an IgG4-related ophthalmic disease (IgG4-ROD) and other patients.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from non-lymphoma, non-thyroid-related orbital inflammation
Key inclusion criteria (1 listed)
- Patient suffering from acute orbital inflammation
Key exclusion criteria (2 listed)
- Thyroid disease
- Lymphoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Infra-orbital nerve enlargement on orbital MRI
Time frame: Within 1 week following diagnosis
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 14 Sep 2016.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Orbital Inflammation, run by Fondation Ophtalmologique Adolphe de Rothschild.
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 1 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 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Infra-orbital nerve enlargement on orbital MRI (time frame: Within 1 week following diagnosis). 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 14 Sep 2016.