Prevalence of Keratoconus in Inflammatory Bowel Diseases (OSCAR)

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Keratoconus
• Intervention / Treatment: Device: Opthalmologic measure with DM OPD scan III (Nidek)

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Keratoconus and IBD; Opthalmologic measure with DM OPD scan III (Nidek)	Device: Opthalmologic measure with DM OPD scan III (Nidek); Bilateral measure of corneal refractometry, pachymetry, topography and aberrometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Karine ANGIOI-DUPREZ, Service d'ophtalmologie- Hôpitaux de Brabois - CHU de NANCY

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: August 3, 2016
• First Submitted That Met QC Criteria: August 5, 2016
• First Posted (Estimate): August 10, 2016

Study Record Updates

• Last Update Posted (Estimate): August 10, 2016
• Last Update Submitted That Met QC Criteria: August 5, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Eye Diseases; Gastrointestinal Diseases; Gastroenteritis; Corneal Diseases; Inflammatory Bowel Diseases; Intestinal Diseases; Keratoconus
• Other Study ID Numbers: 2013-A01680-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

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