Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05286203

Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing

Led by University of California, San Francisco · Updated on 2022-07-07

100

Participants Needed

1

Research Sites

234 weeks

Total Duration

On this page

Sponsors

U

University of California, San Francisco

Lead Sponsor

U

University of Nebraska

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Presumed infectious anterior uveitis, intermediate uveitis, posterior uveitis, or panuveitis
  • Presumed post-operative endophthalmitis
  • Unilateral or bilateral eye involvement
  • 18 years and older
Not Eligible

You will not qualify if you...

  • Insufficient specimen for MDS testing
  • Under 18 years of age
  • Pregnancy
  • Unable to consent

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California San Francisco (UCSF)

San Francisco, California, United States, 94158

Actively Recruiting

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Research Team

J

Jessica Shantha, MD

CONTACT

T

Thuy Doan, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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