Evaluation of a Standardized Strategy for Uveitis Etiological Diagnosis (ULISSE)

Civil Hospices of Lyon

Status: Completed

Conditions: Uveitis

Treatments: Other: Standardized strategy; Other: Free strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT01162070

2009.566/19

Details and patient eligibility

About

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.

Enrollment: 905 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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905 participants in 2 patient groups

Free strategy

Active Comparator group

Description:

Free strategy followed in order to make the etiological diagnosis, which means, investigators are free to perform any examination they thought necessary.

Treatment:

Other: Free strategy

Experimental strategy

Experimental group

Description:

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).

Treatment:

Other: Standardized strategy