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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
100
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.
SOC includes any available diagnostic tests, such as Gram stain, cultures, PCRs, that are considered the appropriate testing based on the clinical findings.
University of California San Francisco (UCSF)
San Francisco, California, United States
Clinical Improvement 2-step Decrease in the Level of Inflammation or Decrease to Grade 0; Inflammatory Retinal/Choroidal Lesions Reducing in Size; 20% Improvement of CST on Optical Coherence Tomography, a > 10- Letter Improvement in Visual Acuity,
Dichotomous variable (Y/N) as assessed by a masked evaluator
Time frame: 4-week after randomization
Appropriate Therapy
Dichotomous variable (Y/N) as determined by an independent expert panel
Time frame: 4-week after randomization
Provider Certainty of Belief
Provider certainty of belief that the patient has an infection (continuous variable from 0 to 100%, 0% signifying uncertain and 100% signifying certain)
Time frame: 4-week after randomization
Patient Quality of Life
As measured by National Eye Institute Vision Function Questionnaire (min = 0, max = 100; higher means better vision function)
Time frame: 4-week after randomization
Comparative Sensitivity of the Physician, Conventional Diagnostics, and MDS Using Latent Class Analysis
Latent Class Analysis (LCA) was used to estimate the sensitivity of three diagnostic approaches: (1) clinical diagnosis by the treating physician at presentation, (2) conventional diagnostics, and (3) MDS. LCA was performed on all randomized participants with infection status, evaluating the diagnostic performance of treating physicians, conventional diagnostics, and MDS. A total of 100 participants were enrolled in Phase l of the OPTICS trial.
Time frame: Conclusion of study. 4 weeks after randomization.
Comparative Specificity of the Physician, Conventional Diagnostics, and MDS Using Latent Class Analysis
Latent Class Analysis (LCA) was used to estimate the specificity of three diagnostic approaches: (1) clinical diagnosis by the treating physician at presentation, (2) conventional diagnostics, and (3) MDS. LCA was performed on all randomized participants with infection status, evaluating the diagnostic performance of treating physicians, conventional diagnostics, and MDS. A total of 100 participants were enrolled in Phase l of the OPTICS trial.
Time frame: Conclusion of study. 4 weeks after randomization
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