Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing (OPTICS)

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Uveitis; Infectious Disease

Treatments: Diagnostic Test: Standard of Care (SOC); Device: Metagenomic Deep Sequencing (MDS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05286203

P0555674

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

Patients enrolled in the trial and randomized to the standard of care (SOC) arm will undergo standard of care testing.

Treatment:

Diagnostic Test: Standard of Care (SOC)

MDS

Experimental group

Description:

Patients enrolled in the trial and randomized to the MDS arm will undergo standard of care testing and MDS testing.

Treatment:

Device: Metagenomic Deep Sequencing (MDS)