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Completed

NCT Number: NCT05286203

Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing

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.

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Key information

Conditions

Uveitis Communicable Diseases Disease Attributes Eye Diseases Infections Infectious Disease Pathologic Processes Pathological Conditions, Signs and Symptoms Uveal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco (UCSF)

San Francisco, California, 94158, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metagenomic Deep Sequencing (MDS)

Device

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.

Standard of Care (SOC)

Diagnostic Test

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

Primary outcomes

  1. 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,

    Time frame: 4-week after randomization

    Dichotomous variable (Y/N) as assessed by a masked evaluator

  2. Appropriate Therapy

    Time frame: 4-week after randomization

    Dichotomous variable (Y/N) as determined by an independent expert panel

Secondary outcomes

  1. Provider Certainty of Belief

    Time frame: 4-week after randomization

    Provider certainty of belief that the patient has an infection (continuous variable from 0 to 100%, 0% signifying uncertain and 100% signifying certain)

  2. Patient Quality of Life

    Time frame: 4-week after randomization

    As measured by National Eye Institute Vision Function Questionnaire (min = 0, max = 100; higher means better vision function)

  3. Comparative Sensitivity of the Physician, Conventional Diagnostics, and MDS Using Latent Class Analysis

    Time frame: Conclusion of study. 4 weeks after randomization.

    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.

  4. Comparative Specificity of the Physician, Conventional Diagnostics, and MDS Using Latent Class Analysis

    Time frame: Conclusion of study. 4 weeks after randomization

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Research to Prevent Blindness
  • University of California, Davis
  • University of California, Los Angeles
  • University of Nebraska
  • University of Utah

Registry information

Acronym: OPTICS

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 18, 2022
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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