Clinical trial NCT01162070: Evaluation of a Standardized Strategy for Uveitis Etiological Diagnosis
Official title: Uveitis: Medico-economical and Clinical Evaluation of a Standardized Strategy for an Etiological Diagnosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uveitis
Keywords: Uveitis
etiological diagnosis
standardized strategy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2010-07-14
Enrollment: 905
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The primary outcome is the percentage of patients having an etiological diagnosis 6 months after the beginning of the study for both strategies.
timeFrame: 6 months
Secondary outcomes:
measure: Clinical criteria concerning the standardized strategy
timeFrame: 6 months
measure: Clinical criteria concerning the free strategy
timeFrame: 6 months
measure: The average cost of economic criteria for each strategy.
timeFrame: 12 months
measure: Quality of life criteria
timeFrame: : 6 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de Médecine Interne, Hospices Civils de Lyon (HCL)-Hôpital de la Croix Rousse
Study officials:
References:
citation: de Parisot A, Kodjikian L, Errera MH, Sedira N, Heron E, Perard L, Cornut PL, Schneider C, Riviere S, Olle P, Pugnet G, Cathebras P, Manoli P, Bodaghi B, Saadoun D, Baillif S, Tieulie N, Andre M, Chiambaretta F, Bonin N, Bielefeld P, Bron A, Mouriaux F, Bienvenu B, Vicente S, Bin S, Broussolle C, Decullier E, Seve P; ULISSE group. Randomized Controlled Trial Evaluating a Standardized Strategy for Uveitis Etiologic Diagnosis (ULISSE). Am J Ophthalmol. 2017 Jun;178:176-185. doi: 10.1016/j.ajo.2017.03.029. Epub 2017 Mar 31.