Ocular Manifestations of Inflammatory Bowel Disease | NCT04771039

Studies
Ocular Manifestations of Inflammatory Bowel Disease

NCT04771039

Sponsor

Central Hospital, Nancy, France

Status

Completed

Last Update Posted

Feb 25, 2021Actual

Enrollment

87Actual

Phase

Not provided

Conditions

Inflammatory Bowel Diseases
Ophthalmopathy

Interventions

reason for consultation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2013Actual

Primary Completion Date

Dec 1, 2020Actual

Completion Date

Dec 12, 2020Actual

First Submitted Date

Jan 4, 2021

First Submission Date that Met QC Criteria

Feb 24, 2021

First Posted Date

Feb 25, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2021

Last Update Posted Date

Feb 25, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 CHRU and describe all the ocular manifestations that can be found.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients with chronic inflammatory bowel disease who consulted in ophthalmology			Other: reason for consultation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
reason for consultation	Other	search in medical files for reasons for ophthalmology consultation, functional signs, clinical signs, treatment, characteristics of IBD	patients with chronic inflammatory bowel disease who consulted in ophthalmology

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
frequency	frequency of ocular manifestations in inflammatory bowel disease	baseline

Secondary Outcomes

Measure	Description	Time Frame
Number	Number of uveitis, scleritis and episcleritis; prevalence calculation	baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients followed at Nancy University Hospital for IBD and having consulted in the ophthalmology department

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005128	Eye Diseases

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012017	Referral and Consultation

Ancestor Terms

ID	Term
D011364	Professional Practice
D009934	Organization and Administration
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided