Prevalence of Keratoconus in Inflammatory Bowel Diseases

Inflammatory Bowel Diseases Clinical Trial

— OSCAR  

Official title:

Prevalence of Keratoconus in Inflammatory Bowel Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02861339
• Other study ID #: 2013-A01680-45
• Status: Completed
• Phase: N/A
• First received: August 3, 2016
• Last updated: August 5, 2016
• Start date: February 2014
• Est. completion date: July 2014

Study information

• Verified date: August 2016
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases
• Keratoconus

Intervention

Device:
• Opthalmologic measure with DM OPD scan III (Nidek)
Bilateral measure of corneal refractometry, pachymetry, topography and aberrometry

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	IBD clinical features using the Montreal classification for IBD		day 0	No