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Completed

NCT Number: NCT02861339

Prevalence of Keratoconus in Inflammatory Bowel Diseases

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.

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Key information

Conditions

Inflammatory Bowel Diseases Corneal Diseases Digestive System Diseases Eye Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Keratoconus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Opthalmologic measure with DM OPD scan III (Nidek)

Device

Bilateral measure of corneal refractometry, pachymetry, topography and aberrometry

Primary outcomes

  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 outcomes

  1. IBD clinical features using the Montreal classification for IBD

    Time frame: day 0

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: OSCAR

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 10, 2016
Registry last updated
Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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