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Prevalence of Keratoconus in Inflammatory Bowel Diseases (OSCAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02861339
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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.


Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Keratoconus Device: Opthalmologic measure with DM OPD scan III (Nidek) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Prevalence of Keratoconus in Inflammatory Bowel Diseases
Study Start Date : February 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Absence or presence of keratoconus in IBD patients [ Time Frame: day 0 ]
    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.


Secondary Outcome Measures :
  1. IBD clinical features using the Montreal classification for IBD [ Time Frame: day 0 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861339


Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Karine ANGIOI-DUPREZ Service d'ophtalmologie- Hôpitaux de Brabois - CHU de NANCY
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02861339    
Other Study ID Numbers: 2013-A01680-45
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Keratoconus
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Corneal Diseases
Eye Diseases