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Clinical Trials/NCT01162070
NCT01162070
Completed
Not Applicable

Uveitis: Medico-economical and Clinical Evaluation of a Standardized Strategy for an Etiological Diagnosis

Hospices Civils de Lyon1 site in 1 country905 target enrollmentJune 1, 2010
ConditionsUveitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Uveitis
Sponsor
Hospices Civils de Lyon
Enrollment
905
Locations
1
Primary Endpoint
The primary outcome is the percentage of patients having an etiological diagnosis 6 months after the beginning of the study for both strategies.
Status
Completed
Last Updated
8 months ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
June 1, 2010
End Date
July 1, 2014
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

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.

Secondary Outcomes

  • Clinical criteria concerning the standardized strategy(6 months)
  • Clinical criteria concerning the free strategy(6 months)
  • The average cost of economic criteria for each strategy.(12 months)
  • Quality of life criteria(: 6 months)

Study Sites (1)

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