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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

Tracking Information
First Submitted Date March 14, 2019
First Posted Date March 15, 2019
Last Update Posted Date March 15, 2019
Actual Study Start Date January 1, 2016
Estimated Primary Completion Date January 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 14, 2019)
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)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Lyon Uveitis Study
Official Title Lyon Uveitis Study
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Uveitis
Intervention Other: No specific intervention. Collection of clinical data
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 14, 2019)
750
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2023
Estimated Primary Completion Date January 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Pascal Sève, MD, PhD +33-4 26 73 26 27 pascal.seve@chu-lyon.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03877575
Other Study ID Numbers CRC_GHN_2019_003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators Not Provided
PRS Account Hospices Civils de Lyon
Verification Date March 2019