Inflammatory Bowel DiseasesNCT04771039
Ocular Manifestations of Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases and Ophthalmopathy, run by Central Hospital, Nancy, France.
Trial summary
Ocular damage is found in the 3rd rank of extra intestinal manifestations (MEI) Potentially serious functional complications (see uveitis and risk of blindness) requiring rapid management Rare uveitis in the literature (0.5% -3%), study on a large sample to assess their prevalence in patients with IBD at the Nancy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Ophthalmopathy
- What is being tested?
- reason for consultation
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 12 Dec 2020
- 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: Adult patients followed at Nancy University Hospital for IBD and having consulted in the ophthalmology department
Who may be able to join
- Adult patients followed at Nancy University Hospital for IBD and having consulted in the ophthalmology department
Who cannot join
- Minor patients
- patients without IBD
- patients for whom there is no ophthalmology consultation
About this study
Official title: Ocular Manifestations of Chronic Inflammatory Bowel Disease (IBD): Retrospective Study in the Hepato-gastroenterology Department of the Nancy CHRU
Ocular damage is found in the 3rd rank of extra intestinal manifestations (MEI) Potentially serious functional complications (see uveitis and risk of blindness) requiring rapid management Rare uveitis in the literature (0.5% -3%), study on a large sample to assess their prevalence in patients with IBD at the Nancy CHRU and describe all the ocular manifestations that can be found.
- Conditions
- Inflammatory Bowel Diseases, Ophthalmopathy
- Being tested
- reason for consultation
- Medical subject headings
- Inflammatory Bowel Diseases, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reason for consultationOther
search in medical files for reasons for ophthalmology consultation, functional signs, clinical signs, treatment, characteristics of IBD
| Study group | Role | What they receive |
|---|---|---|
| patients with chronic inflammatory bowel disease who consulted in ophthalmology | Not described Receives: Other: reason for consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency
frequency of ocular manifestations in inflammatory bowel disease
Measured: baseline
Secondary outcomes (1)
Number
Number of uveitis, scleritis and episcleritis; prevalence calculation
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Jan 2013
- Primary completion1 Dec 2020
- Study completion12 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771039
- Sponsor's protocol ID
- HRIPH
- Status last verified
- Dec 2020
- First submitted
- 4 Jan 2021
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Manifestations of Chronic Inflammatory Bowel Disease (IBD): Retrospective Study in the Hepato-gastroenterology Department of the Nancy CHRU
- ClinicalTrials.gov ID
- NCT04771039
- Acronym / sponsor ID
- HRIPH
- Conditions
- Inflammatory Bowel Diseases, Ophthalmopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 12 Dec 2020 (actual)
- First posted
- 25 Feb 2021 (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.
Ocular damage is found in the 3rd rank of extra intestinal manifestations (MEI) Potentially serious functional complications (see uveitis and risk of blindness) requiring rapid management Rare uveitis in the literature (0.5% -3%), study on a large sample to assess their prevalence in patients with IBD at the Nancy CHRU and describe all the ocular manifestations that can be found.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with chronic inflammatory bowel disease who consulted in ophthalmology | – | Other: reason for consultation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients followed at Nancy University Hospital for IBD and having consulted in the ophthalmology department
Key inclusion criteria (1 listed)
- Adult patients followed at Nancy University Hospital for IBD and having consulted in the ophthalmology department
Key exclusion criteria (3 listed)
- Minor patients
- patients without IBD
- patients for whom there is no ophthalmology consultation
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 |
|---|---|---|
| reason for consultationsearch in medical files for reasons for ophthalmology consultation, functional signs, clinical signs, treatment, characteristics of IBD | Other | patients with chronic inflammatory bowel disease who consulted in ophthalmology |
Primary outcome
frequency
Time frame: baseline
frequency of ocular manifestations in inflammatory bowel disease
1 secondary outcome
Number
Time frame: baseline
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 25 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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 Inflammatory Bowel Diseases and Ophthalmopathy, run by Central Hospital, Nancy, France.
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 3 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 25 Feb 2021. 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?
frequency (time frame: baseline). 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 25 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.