Inflammatory Bowel DiseasesOSCARNCT02861339
Prevalence of Keratoconus in Inflammatory Bowel Diseases
A study testing Opthalmologic measure with DM OPD scan III (Nidek) in people with Inflammatory Bowel Diseases and Keratoconus, run by Central Hospital, Nancy, France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Keratoconus
- What is being tested?
- Opthalmologic measure with DM OPD scan III (Nidek)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Affiliation to social security plan
- Diagnosis of IBD since more than 3 years, under treatment or not
Who cannot join
- Protected person
- Pregnant or breastfeeding women
- Person in life-and-death emergency
- Person deprived of liberty
- Refusal to remove contact lenses, where necessary
About this study
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.
- Conditions
- Inflammatory Bowel Diseases, Keratoconus
- Being tested
- Opthalmologic measure with DM OPD scan III (Nidek)
- Medical subject headings
- Inflammatory Bowel Diseases, Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opthalmologic measure with DM OPD scan III (Nidek)Device
Bilateral measure of corneal refractometry, pachymetry, topography and aberrometry
| Study group | Role | What they receive |
|---|---|---|
| Keratoconus and IBD | Experimental | Opthalmologic measure with DM OPD scan III (Nidek) Receives: Device: Opthalmologic measure with DM OPD scan III (Nidek) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 0
Secondary outcomes (1)
IBD clinical features using the Montreal classification for IBD
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karine ANGIOI-DUPREZ, Principal investigator, Service d'ophtalmologie- Hôpitaux de Brabois - CHU de NANCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861339
- Sponsor's protocol ID
- 2013-A01680-45
- Acronym
- OSCAR
- Status last verified
- Aug 2016
- First submitted
- 3 Aug 2016
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Keratoconus in Inflammatory Bowel Diseases
- ClinicalTrials.gov ID
- NCT02861339
- Acronym / sponsor ID
- OSCAR / 2013-A01680-45
- Conditions
- Inflammatory Bowel Diseases, Keratoconus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Keratoconus and IBD | Experimental | Device: Opthalmologic measure with DM OPD scan III (Nidek)Opthalmologic measure with DM OPD scan III (Nidek) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent
- Affiliation to social security plan
- Diagnosis of IBD since more than 3 years, under treatment or not
Key exclusion criteria (5 listed)
- Protected person
- Pregnant or breastfeeding women
- Person in life-and-death emergency
- Person deprived of liberty
- Refusal to remove contact lenses, where necessary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opthalmologic measure with DM OPD scan III (Nidek)Bilateral measure of corneal refractometry, pachymetry, topography and aberrometry | Device | Keratoconus and IBD |
Primary outcome
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.
1 secondary outcome
IBD clinical features using the Montreal classification for IBD
Time frame: day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
- Individual participant dataSharing planned: No
Related trials for Inflammatory Bowel Diseases
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karine ANGIOI-DUPREZ principal investigator
Service d'ophtalmologie- Hôpitaux de Brabois - CHU de NANCY
Questions about this trial
What is this clinical trial studying?
A study testing Opthalmologic measure with DM OPD scan III (Nidek) in people with Inflammatory Bowel Diseases and Keratoconus, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence or presence of keratoconus in IBD patients (time frame: day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016.