- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04771039
Ocular Manifestations of Inflammatory Bowel Disease
February 24, 2021 updated by: Central Hospital, Nancy, France
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
87
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
Sampling Method
Non-Probability Sample
Study Population
Adult patients followed at Nancy University Hospital for IBD and having consulted in the ophthalmology department
Description
Inclusion Criteria:
- Adult patients followed at Nancy University Hospital for IBD and having consulted in the ophthalmology department
Exclusion Criteria:
- Minor patients
- patients without IBD
- patients for whom there is no ophthalmology consultation
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
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patients with chronic inflammatory bowel disease who consulted in ophthalmology
|
search in medical files for reasons for ophthalmology consultation, functional signs, clinical signs, treatment, characteristics of IBD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
frequency
Time Frame: baseline
|
frequency of ocular manifestations in inflammatory bowel disease
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number
Time Frame: baseline
|
Number of uveitis, scleritis and episcleritis; prevalence calculation
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 1, 2013
Primary Completion (Actual)
December 1, 2020
Study Completion (Actual)
December 12, 2020
Study Registration Dates
First Submitted
January 4, 2021
First Submitted That Met QC Criteria
February 24, 2021
First Posted (Actual)
February 25, 2021
Study Record Updates
Last Update Posted (Actual)
February 25, 2021
Last Update Submitted That Met QC Criteria
February 24, 2021
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HRIPH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.