Prevalence of Keratoconus in Inflammatory Bowel Diseases
OSCAR
1 other identifier
interventional
201
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2014
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 3, 2016
CompletedFirst Posted
Study publicly available on registry
August 10, 2016
CompletedAugust 10, 2016
August 1, 2016
5 months
August 3, 2016
August 5, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 (1)
IBD clinical features using the Montreal classification for IBD
day 0
Study Arms (1)
Keratoconus and IBD
EXPERIMENTALOpthalmologic measure with DM OPD scan III (Nidek)
Interventions
Bilateral measure of corneal refractometry, pachymetry, topography and aberrometry
Eligibility Criteria
You may qualify if:
- Informed consent
- Affiliation to social security plan
- Diagnosis of IBD since more than 3 years, under treatment or not
You may not qualify if:
- Protected person
- Pregnant or breastfeeding women
- Person in life-and-death emergency
- Person deprived of liberty
- Refusal to remove contact lenses, where necessary
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karine ANGIOI-DUPREZ
Service d'ophtalmologie- Hôpitaux de Brabois - CHU de NANCY
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2016
First Posted
August 10, 2016
Study Start
February 1, 2014
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
August 10, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share