Prevalence of Keratoconus in Inflammatory Bowel Diseases | NCT02861339

Studies
Prevalence of Keratoconus in Inflammatory Bowel Diseases

NCT02861339

Sponsor

Central Hospital, Nancy, France

Status

Completed

Last Update Posted

Aug 10, 2016Estimated

Enrollment

201Actual

Phase

Not Applicable

Conditions

Inflammatory Bowel Diseases
Keratoconus

Interventions

Opthalmologic measure with DM OPD scan III (Nidek)

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

Aug 2016

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

Feb 2014

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Aug 3, 2016

First Submission Date that Met QC Criteria

Aug 5, 2016

First Posted Date

Aug 10, 2016Estimated

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

Aug 5, 2016

Last Update Posted Date

Aug 10, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

A retrospective study has shown the association between the inflammatory bowel diseases (IBD) and the presence of a keratoconus. This new study will measure the prevalence of keratoconus and follow its activity in patients affected by IBD and followed up in hepatology-gastroenterology department at Nancy Hospital. The prevalence of keratoconus will be compared to known data of literature about general population.

The secondary purpose is to search for a relationship between the presence of a keratoconus and activity criteria of IBD.

Perspectives are a systematic screening for keratoconus in patients affected by IBD with the amelioration of the ophthalmologic care of IBD patients and confirmation of the recent hypothesis of inflammatory origin of keratoconus.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

201Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Keratoconus and IBD	Experimental	Opthalmologic measure with DM OPD scan III (Nidek)	Device: Opthalmologic measure with DM OPD scan III (Nidek)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Opthalmologic measure with DM OPD scan III (Nidek)	Device	Bilateral measure of corneal refractometry, pachymetry, topography and aberrometry	Keratoconus and IBD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Absence or presence of keratoconus in IBD patients	Data from OPD scan III corneal analyzer according to Rabinowitz and Klyce Maeda criteria. The presence of a keratoconus in at least one eye is considered positive.	day 0

Secondary Outcomes

Measure	Description	Time Frame
IBD clinical features using the Montreal classification for IBD		day 0

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed consent
Affiliation to social security plan
Diagnosis of IBD since more than 3 years, under treatment or not

Exclusion Criteria:

Protected person
Pregnant or breastfeeding women
Person in life-and-death emergency
Person deprived of liberty
Refusal to remove contact lenses, where necessary

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karine ANGIOI-DUPREZ	Service d'ophtalmologie- Hôpitaux de Brabois - CHU de NANCY	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

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
D007640	Keratoconus

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided