- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01162070
Evaluation of a Standardized Strategy for Uveitis Etiological Diagnosis (ULISSE)
Uveitis: Medico-economical and Clinical Evaluation of a Standardized Strategy for an Etiological Diagnosis
The Uveitis, the inflammation of the uvea, is a rare disease with an incidence of 52/100,000 inhabitants per year and a prevalence of 115 / 100,000 inhabitants per year.
The causes of uveitis are numerous and include infectious diseases, systemic and neurological diseases, ophthalmic entities, neoplasia, and drug-related reactions. The etiological diagnosis is important both for prognosis and therapeutics.
However, clinical evaluations to establish etiological diagnosis are not standardized. Some authors suggest a minimalist examination, common to all kinds of uveitis. On the other hand, others propose an evaluation guided by the anatomo-clinical type of uveitis.
We conducted a retrospective study to assess the contribution of complementary examinations to etiological determination. In this study, we found that most patients benefited from a wide paraclinical evaluation compared to what is usually described in the literature. Complementary examinations were mostly systematic, without any clinical or ophthalmological elements of orientation. This study highlighted the lack of contribution of some examinations.
Using these results, and the literature analysis, we designed a diagnostic algorithm adapted to the anatomo-clinical type of uveitis.
Moreover, we found that the average cost per patient was estimated at €290.51 with the algorithm compared to €560.83 without it.
We would like to carry out a new study to estimate the efficiency as well as the medico-economic impact of the use of a standardized strategy for the etiological diagnosis of uveitis, compared with a free strategy.
Hypothesis:
- The standardized strategy for the diagnostic of uveitis is at least as efficient as the free one, and costs half as much.
- The examinations prescribed, except for those from the standardized strategy, do not contribute to etiological determination.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Lyon, France, 69004
- Service de Médecine Interne, Hospices Civils de Lyon (HCL)-Hôpital de la Croix Rousse
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Uveitis
- Patient consulting one of the study's sites
- Age > 18 years old
- Affiliation to the French national health insurance program
- Patient agreeing to participate in the study
Exclusion Criteria:
- Positive HIV serology
- Postsurgical or posttraumatic uveitis or endophthalmitis
- Toxoplasmic uveitis
- Pathology likely to be the cause of the known uveitis
- Ophthalmic entities only diagnosed by the ophthalmic examination
- Age < 18 years old
- Patient under law protection or guardianship
- Pregnant women or those planning to be pregnant during the study
- Severe uveitis (VA < 20/200) with retinal vascularitis requiring an emergency treatment and assessment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Free strategy
Free strategy followed in order to make the etiological diagnosis, which means, investigators are free to perform any examination they thought necessary.
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Free strategy followed in order to make the etiological diagnosis, which means, investigators are free to perform any examination they thought necessary.
Other Names:
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Experimental: Experimental strategy
Etiological diagnosis made by following a standardized two-stage strategy: first-line assessment (listed examinations and then examinations directed by the clinical or para-clinical elements of orientation) and second or third-line assessment (examinations directed by the anatomo-clinical type of uveitis).
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Etiological diagnosis made by following a standardized two-stage strategy: first-line assessment (listed examinations and then examinations directed by the clinical or para-clinical elements of orientation) and second or third-line assessment (examinations directed by the anatomo-clinical type of uveitis).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The primary outcome is the percentage of patients having an etiological diagnosis 6 months after the beginning of the study for both strategies.
Time Frame: 6 months
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Note: Only diagnoses made at the end of the standardized strategy will be numbered in this arm of the study; all diagnoses made after by the free authorized examinations in this same arm will lead to standardized strategy failure.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical criteria concerning the standardized strategy
Time Frame: 6 months
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6 months
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Clinical criteria concerning the free strategy
Time Frame: 6 months
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6 months
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The average cost of economic criteria for each strategy.
Time Frame: 12 months
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12 months
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Quality of life criteria
Time Frame: : 6 months
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- Quality of life, estimated with the standard quality of life questionnaire (SF-36) and the one specific to ophthalmology (NEI VFQ-25), will be compared between these groups:
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: 6 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009.566/19
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Uveitis
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Priovant Therapeutics, Inc.Active, not recruitingNon-infectious Intermediate Uveitis | Non-infectious Posterior Uveitis | Non-infectious Pan UveitisUnited States
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University of NebraskaUnknownPosterior Uveitis | Intermediate Uveitis | Pan-uveitisUnited States
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Stanford UniversitySanten Inc.WithdrawnPanuveitis | Uveitis | Posterior Uveitis | Intermediate UveitisUnited States
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CHU de Quebec-Universite LavalCompletedIntermediate Uveitis | Anterior UveitisCanada
-
EyePoint Pharmaceuticals, Inc.CompletedPanuveitis | Posterior Uveitis | Intermediate UveitisIndia
-
Johns Hopkins UniversityMacuSight, Inc.CompletedPanuveitis | Uveitis | Posterior Uveitis | Intermediate UveitisUnited States
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Novartis PharmaceuticalsCompletedNon-infectious Intermediate Uveitis | Non-infectious Posterior Uveitis | Non-infectious PanuveitisUnited States, United Kingdom
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The New York Eye & Ear InfirmaryUnknownPanuveitis | Uveitis | Posterior Uveitis | Anterior UveitisUnited States
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Duke UniversityCompletedPosterior Uveitis | Intermediate UveitisUnited States
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AllerganCompletedPosterior Uveitis | Intermediate UveitisFrance, United Kingdom, United States, Spain, Poland, India, South Africa, Korea, Republic of, Canada, Czech Republic, Australia, Germany, Israel, Switzerland, Portugal, Austria, Brazil, Greece
Clinical Trials on Free strategy
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Hospices Civils de LyonNot yet recruiting
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China National Center for Cardiovascular DiseasesUnknown
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Centre Hospitalier Universitaire de NīmesCompletedCentral Venous CatheterizationFrance
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Assistance Publique - Hôpitaux de ParisMinistry of Health, FranceCompleted
-
Yale UniversityNational Institute of Allergy and Infectious Diseases (NIAID); National Heart...CompletedTuberculosis | Tuberculosis, PulmonaryUganda
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Alliance for International Medical ActionHarvard School of Public Health (HSPH); University of Bordeaux, INSERM, Bordeaux...CompletedAcute Malnutrition in Infancy (Disorder)Niger
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Medical University of South CarolinaCompleted
-
University Hospital, AngersRecruitingPhysical Activity | AgedFrance
-
University Hospital, AngersUnknownAcute Respiratory Distress SyndromeFrance
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RTI InternationalNational Institute on Drug Abuse (NIDA)CompletedSubstance UseUnited States