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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01162070
First received: July 12, 2010
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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.

Condition Intervention
Uveitis
Other: Free strategy
Other: Standardized strategy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Uveitis: Medico-economical and Clinical Evaluation of a Standardized Strategy for an Etiological Diagnosis

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Clinical criteria concerning the standardized strategy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    • Percentage of patients having an established etiological diagnosis at the end of the first diagnostic stage and at the end of the second diagnostic stage. (Second or third-line assessment).
    • Ratio of the standardized strategy's first stage examinations having contributed to the etiological diagnosis.
    • Ratio of the standardized strategy's second stage examinations, directed by the anatomo-clinical type of the uveitis (Second or third-line assessment) having contributed to an etiological diagnosis.
    • Ratio of free complementary examinations having contributed to an etiological diagnosis.

  • Clinical criteria concerning the free strategy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    • Description and ratio of the examinations that have not allowed the doctor to make an etiological diagnosis.
    • Description and ratio of the complementary examinations not included in the standardized strategy.

  • The average cost of economic criteria for each strategy. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    • For each patient: The standardized strategy's average cost of diagnosis distinguishing between first diagnostic stage costs and second diagnostic stage costs (made up of the second or third-line assessment directed by the anotomo-clinical type of the uveitis).
    • Average cost of the complementary examinations not included in the standardized strategy but allowed at the end of it (subsequent free assessment).
    • Average cost for each patient of the whole free strategy.

  • Quality of life criteria [ Time Frame: : 6 months ] [ Designated as safety issue: No ]

    - 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:

    1. Uveitis diagnosis versus no diagnosis
    2. Free strategy versus standardized strategy.


Estimated Enrollment: 894
Study Start Date: June 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Free strategy
Free strategy followed in order to make the etiological diagnosis, which means, investigators are free to perform any examination they thought necessary.
Other Name: Procedure or strategy leading to the etiological diagnosis of the uveitis.
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).
Other: Standardized 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162070

Locations
France
Service de Médecine Interne, Hospices Civils de Lyon (HCL)-Hôpital de la Croix Rousse
Lyon, France, 69004
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01162070     History of Changes
Other Study ID Numbers: 2009.566/19
Study First Received: July 12, 2010
Last Updated: October 7, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Uveitis
etiological diagnosis
standardized strategy

Additional relevant MeSH terms:
Uveitis
Chorioretinitis
Uveal Diseases
Eye Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
Uveitis, Posterior
Panuveitis

ClinicalTrials.gov processed this record on April 17, 2014