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Lyon Uveitis Study (LYS)

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ClinicalTrials.gov Identifier: NCT03877575
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Uveitis or inflammation of the uveal tract results from a heterogeneous collection of disorders of varying etiologies and pathogenic mechanisms. Uveitis is relatively frequent in industrial countries with an estimation of 115 cases for 100 000 persons and is associated with a blindness risk of 10%. Causes of uveitis can be related to different etiologies (infectious, inflammatory or general inflammatory diseases). Therapeutic care is based on ophthalmologic and systemic diagnosis and treatment strategy depends on the severity of inflammation.

The main objective of the Lyon uveitis study is to analyze the uveitis ophthalmologic etiology and diagnostic and therapeutic care of the patients. This study is proposed to all patients diagnosed for uveitis and referred to the Department of Internal Medicine of the Croix Rousse hospital, Lyon, france for etiologic diagnosis or treatment.

Analysis of i) patients' characteristics, ii) the relevance of complementary exams to determine the uveitis etiology, iii) treatment used.

This study will allow a better characterization of the disease on diagnosis practices and therapeutic care.


Condition or disease Intervention/treatment
Uveitis Other: No specific intervention. Collection of clinical data

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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lyon Uveitis Study
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Clinical evolution (persistence or resolution) evaluated by gradation of SEN [ Time Frame: At one year after diagnosis ]
    Persistence of disease is characterized by persistence of intraocular inflammation evaluated by gradation of SEN. (reference: A Standardization Grading System for Scleritis . Ophthalmology 2011 Apr;118(4):768-71). SEN score ranges from 0 to 5 (resolution = score 0 and persistence = score >0)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
This study is proposed to all patients diagnosed for uveitis and referred to the Department of Internal Medicine of the Croix-Rousse hospital, Lyon, France for the first visit corresponding to etiologic diagnosis or treatment.
Criteria

Inclusion Criteria:

  • Diagnosis of uveitis
  • First consultation in the Department of Internal Medicine at the Croix-Rousse hospital, Lyon, France

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877575


Contacts
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Contact: Pascal Sève, MD, PhD +33-4 26 73 26 27 pascal.seve@chu-lyon.fr

Locations
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France
Department of Internal Medicine, Croix-Rousse Hospital, Hospices Civils de Lyon Recruiting
Lyon, France, 69004
Contact: Pascal Sève, MD, PhD    +33-4 26 73 26 27    pascal.seve@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03877575     History of Changes
Other Study ID Numbers: CRC_GHN_2019_003
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Uveitis
Uveal Diseases
Eye Diseases