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

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ClinicalTrials.gov Identifier: NCT01162070
Recruitment Status : Completed
First Posted : July 14, 2010
Last Update Posted : May 28, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE July 12, 2010
First Posted Date  ICMJE July 14, 2010
Last Update Posted Date May 28, 2019
Study Start Date  ICMJE June 2010
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2010)
  • Clinical criteria concerning the standardized strategy [ Time Frame: 6 months ]
    • 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 ]
    • 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 ]
    • 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 ]
    - 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of a Standardized Strategy for Uveitis Etiological Diagnosis
Official Title  ICMJE Uveitis: Medico-economical and Clinical Evaluation of a Standardized Strategy for an Etiological Diagnosis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Uveitis
Intervention  ICMJE
  • 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.
  • 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).
Study Arms  ICMJE
  • 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.
    Intervention: Other: Free strategy
  • 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).
    Intervention: Other: Standardized strategy
Publications * de Parisot A, Kodjikian L, Errera MH, Sedira N, Heron E, Pérard L, Cornut PL, Schneider C, Rivière S, Ollé P, Pugnet G, Cathébras 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, Sève 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2016)
905
Original Estimated Enrollment  ICMJE
 (submitted: July 13, 2010)
894
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01162070
Other Study ID Numbers  ICMJE 2009.566/19
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Hospices Civils de Lyon
Original Responsible Party Pr Pascal SEVE, Hospices Civils de Lyon,Service de médecine interne,Centre Hospitalier Universitaire de l'Hôtel Dieu,1 place de l'hôpital 69288 Cedex 2
Current Study Sponsor  ICMJE Hospices Civils de Lyon
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospices Civils de Lyon
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP