- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06102408
Relevance and Efficiency of SecOnd Line Workup for Uveitis (RESOLVE)
October 25, 2023 updated by: Thomas MOULINET, Central Hospital, Nancy, France
The first-line etiological workup is currently poorly codified, and some patients undergo sequential investigations.
However, the reason which lead the clinician to perform subsequent exams, and the relevance of such exams, remain to be determined.
The main objective of the study was to assess the relevance of a second-line workup of patients with uveitis.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
The first-line etiological workup is currently poorly codified, with some patients undergoing extensive investigations, and other minimal etiological workup.
In addition, some patients undergo sequential investigations.
However, the reason which lead the clinician to perform subsequent exams, and the relevance of investigations performed after a first line workup remain to be determined.
The main objective of the study was to assess the relevance of a second-line workup of patients with uveitis.Secondary objectives were to describe the reasons of these second-line workups, and to determine which exams were the most relevant, and the determinants of its realization.
Study Type
Observational
Enrollment (Estimated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Thomas Moulinet, MD
- Phone Number: +3383155304
- Email: t.moulinet@chru-nancy.fr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
adult pateints with uveitis requiring at least one etiological workup.
Description
Inclusion Criteria:
- adult patient
- at least one etiological workup in our center
Exclusion Criteria:
- only episode of acute anterior uveitis quickly responding to topical treatments
- diagnostic ophthalmologically obvious
- opposition to collection of data
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with only one etiological workup
patients who underwent only one set of exams for etiological investigations of uveitis
|
Biological, radiological or histological investigations performed after a first line etiological workup.
Investigations conducted following abnormal resultats of first line exams were not considered as second line exams (e.g.
: bronchoscopy performed after abrnomal CT scan).
|
Patients without diagnostic modification subsequently to the second etiological workup
Patients who underwent a second etiological workup, independently of the results of the fist line investigations, and whose diagnosis was not modified by the second line investigations.
|
Biological, radiological or histological investigations performed after a first line etiological workup.
Investigations conducted following abnormal resultats of first line exams were not considered as second line exams (e.g.
: bronchoscopy performed after abrnomal CT scan).
|
Patients with diagnostic modification subsequently to the second etiological workup
Patients who underwent a second etiological workup, independently of the results of the fist line investigations, and whose diagnosis was modified by the second line investigations.
|
Biological, radiological or histological investigations performed after a first line etiological workup.
Investigations conducted following abnormal resultats of first line exams were not considered as second line exams (e.g.
: bronchoscopy performed after abrnomal CT scan).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
patients undergoing a second line etiological workup
Time Frame: through study completion, an average of 18 months
|
percentage of patients undergoing a second line etiological workup
|
through study completion, an average of 18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. doi: 10.1016/j.ajo.2005.03.057.
- Hwang DK, Chou YJ, Pu CY, Chou P. Epidemiology of uveitis among the Chinese population in Taiwan: a population-based study. Ophthalmology. 2012 Nov;119(11):2371-6. doi: 10.1016/j.ophtha.2012.05.026. Epub 2012 Jul 17.
- Dandona L, Dandona R, John RK, McCarty CA, Rao GN. Population based assessment of uveitis in an urban population in southern India. Br J Ophthalmol. 2000 Jul;84(7):706-9. doi: 10.1136/bjo.84.7.706.
- Smith JR, Rosenbaum JT. Management of uveitis: a rheumatologic perspective. Arthritis Rheum. 2002 Feb;46(2):309-18. doi: 10.1002/art.503. No abstract available.
- Selmi C. Diagnosis and classification of autoimmune uveitis. Autoimmun Rev. 2014 Apr-May;13(4-5):591-4. doi: 10.1016/j.autrev.2014.01.006. Epub 2014 Jan 12.
- de Parisot A, Jamilloux Y, Kodjikian L, Errera MH, Sedira N, Heron E, Perard L, Cornut PL, Schneider C, Riviere S, Olle P, Pugnet G, Cathebras 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, Amamra N, Guerre P, Decullier E, Seve P; ULISSE group. Evaluating the cost-consequence of a standardized strategy for the etiological diagnosis of uveitis (ULISSE study). PLoS One. 2020 Feb 14;15(2):e0228918. doi: 10.1371/journal.pone.0228918. eCollection 2020.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 15, 2023
Primary Completion (Estimated)
December 15, 2023
Study Completion (Estimated)
December 25, 2023
Study Registration Dates
First Submitted
October 22, 2023
First Submitted That Met QC Criteria
October 22, 2023
First Posted (Actual)
October 26, 2023
Study Record Updates
Last Update Posted (Actual)
October 27, 2023
Last Update Submitted That Met QC Criteria
October 25, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023PI190
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Uveitis
-
Priovant Therapeutics, Inc.Active, not recruitingNon-infectious Intermediate Uveitis | Non-infectious Posterior Uveitis | Non-infectious Pan UveitisUnited States
-
University of NebraskaUnknownPosterior Uveitis | Intermediate Uveitis | Pan-uveitisUnited States
-
Stanford UniversitySanten Inc.WithdrawnPanuveitis | Uveitis | Posterior Uveitis | Intermediate UveitisUnited States
-
CHU de Quebec-Universite LavalCompletedIntermediate Uveitis | Anterior UveitisCanada
-
Novartis PharmaceuticalsCompletedNon-infectious Intermediate Uveitis | Non-infectious Posterior Uveitis | Non-infectious PanuveitisUnited States, United Kingdom
-
Duke UniversityCompletedPosterior Uveitis | Intermediate UveitisUnited States
-
AllerganCompletedPosterior Uveitis | Intermediate UveitisFrance, United Kingdom, United States, Spain, Poland, India, South Africa, Korea, Republic of, Canada, Czech Republic, Australia, Germany, Israel, Switzerland, Portugal, Austria, Brazil, Greece
-
EyePoint Pharmaceuticals, Inc.CompletedPanuveitis | Posterior Uveitis | Intermediate UveitisIndia
-
Johns Hopkins UniversityMacuSight, Inc.CompletedPanuveitis | Uveitis | Posterior Uveitis | Intermediate UveitisUnited States
-
The New York Eye & Ear InfirmaryUnknownPanuveitis | Uveitis | Posterior Uveitis | Anterior UveitisUnited States
Clinical Trials on second line investigations for uveitis etiological workup
-
Chinese University of Hong KongRecruitingSubstance Abuse | Voiding DysfunctionHong Kong
-
Anhui Medical UniversityUnknownStage IV Gastric Cancer With MetastasisChina
-
Iowa City Veterans Affairs Medical CenterUS Department of Veterans AffairsCompleted
-
Mark Vander WegIowa City VA Health Care SystemUnknownNicotine Dependence | Smokeless TobaccoUnited States