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RECRUITINGINTERVENTIONAL

Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a multi-center randomized controlled evaluator-masked trial designed to compare metagenomic deep sequencing (MDS) versus standard of care testing for improvement of outcomes for intraocular infections. Patients with presumed intraocular infections who meet the eligibility criteria will be randomized to receive MDS testing results or not to receive MDS testing results. All patients will receive standard-of-care testing to guide management. Enrolled patients will be followed at week 2, week 3-6 (randomization visit), and at 4 weeks after the randomization visit. The proportions of patients who received the appropriate therapy and the proportions of patients with improved outcome will be compared between arms. Patient quality of life, MDS performance, and the provider certainly of belief will be collected.

Who May Be Eligible (Plain English)

Who May Qualify: - Presumed infectious anterior uveitis, or intermediate uveitis, or posterior uveitis, or panuveitis - Presumed post-operative endophthalmitis - Unilateral or bilateral - 18 years and older Who Should NOT Join This Trial: - Insufficient specimen for MDS - Age \< 18 years of age - Pregnancy - Unable to consent Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Presumed infectious anterior uveitis, or intermediate uveitis, or posterior uveitis, or panuveitis * Presumed post-operative endophthalmitis * Unilateral or bilateral * 18 years and older Exclusion Criteria: * Insufficient specimen for MDS * Age \< 18 years of age * Pregnancy * Unable to consent

Treatments Being Tested

DEVICE

Metagenomic Deep Sequencing (MDS)

MDS is an RNA-seq based testing of ocular fluid or tissue to identify potential infectious pathogens including bacteria, fungi, parasites, and DNA and RNA viruses.

DIAGNOSTIC_TEST

Standard of Care (SOC)

SOC includes any available diagnostic tests, such as Gram stain, cultures, PCRs, that are considered the appropriate testing based on the clinical findings.

Locations (1)

University of California San Francisco (UCSF)
San Francisco, California, United States