UveitisOPTICSNCT05286203
Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing
A study testing Metagenomic Deep Sequencing (MDS) in people with Uveitis and Infectious Disease, run by University of California, San Francisco at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis, Infectious Disease
- What is being tested?
- Metagenomic Deep Sequencing (MDS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2022to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presumed infectious anterior uveitis, or intermediate uveitis, or posterior uveitis, or panuveitis
- Presumed post-operative endophthalmitis
- Unilateral or bilateral
- 18 years and older
Who cannot join
- Insufficient specimen for MDS
- Age < 18 years of age
- Pregnancy
- Unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco (UCSF)
San Francisco, California, 94158
About this study
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
- Uveitis, Infectious Disease
- Being tested
- Metagenomic Deep Sequencing (MDS), Standard of Care (SOC)
- Keywords
- Uveitis, Metagenomic deep sequencing, Intraocular infection, MDS
- Medical subject headings
- Uveitis, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Patients enrolled in the trial and randomized to the standard of care (SOC) arm will undergo standard of care testing. Receives: Diagnostic Test: Standard of Care (SOC) |
| MDS | Experimental | Patients enrolled in the trial and randomized to the MDS arm will undergo standard of care testing and MDS testing. Receives: Device: Metagenomic Deep Sequencing (MDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4-week after randomization
Appropriate Therapy
Dichotomous variable (Y/N) as determined by an independent expert panel
Measured: 4-week after randomization
Secondary outcomes (4)
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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Conclusion of study. 4 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start6 Jun 2022
- Primary completion31 Jan 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nebraska, University of Utah, University of California, Davis, University of California, Los Angeles, Research to Prevent Blindness
- Responsible party
- Sponsor
- Investigators
- Thuy Doan, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286203
- Sponsor's protocol ID
- P0555674
- Acronym
- OPTICS
- Status last verified
- Jun 2026
- First submitted
- 23 Feb 2022
- Last updated
- 26 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Shantha JG, Moussa K, Laovirojjanakul W, Yeh S, Tsui E, Chen JL, Vitale AT, Shakoor A, Larochelle M, Niemeyer K, Mentreddy A, Livnat I, Safo M, Ao W, Choo C, Yan D, Zhong L, Chen C, Da Silva K, Reddy AK, Lee J, Sura A, Crowell EL, Qian Y, Sharon Y, Hinterwirth A, Porco T, Arnold BF, Gonzales J, Acharya NR, Lietman TM, Doan T; OPTICS Study Group. The Effect of Metagenomic Sequencing on Patient Clinical Outcomes for Intraocular Infections: A Multicenter Randomized Controlled Trial. Am J Ophthalmol. 2025 Nov;279:100-109. doi: 10.1016/j.ajo.2025.07.003. Epub 2025 Jul 11.
PubMed 40653257
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing
- ClinicalTrials.gov ID
- NCT05286203
- Acronym / sponsor ID
- OPTICS / P0555674
- Conditions
- Uveitis, Infectious Disease
- Keywords
- Uveitis, Metagenomic deep sequencing, Intraocular infection, MDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of Nebraska, University of Utah, University of California, Davis, University of California, Los Angeles, Research to Prevent Blindness
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Posted 26 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Diagnostic Test: Standard of Care (SOC)Patients enrolled in the trial and randomized to the standard of care (SOC) arm will undergo standard of care testing. |
| MDS | Experimental | Device: Metagenomic Deep Sequencing (MDS)Patients enrolled in the trial and randomized to the MDS arm will undergo standard of care testing and MDS testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presumed infectious anterior uveitis, or intermediate uveitis, or posterior uveitis, or panuveitis
- Presumed post-operative endophthalmitis
- Unilateral or bilateral
- 18 years and older
Key exclusion criteria (4 listed)
- Insufficient specimen for MDS
- Age < 18 years of age
- Pregnancy
- Unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | MDS |
| 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. | Diagnostic test | Standard of Care |
Primary outcome
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
Appropriate Therapy
Time frame: 4-week after randomization
Dichotomous variable (Y/N) as determined by an independent expert panel
4 secondary outcomes
Provider Certainty of Belief
Time frame: 4-week after randomization
Patient Quality of Life
Time frame: 4-week after randomization
Comparative Sensitivity of the Physician, Conventional Diagnostics, and MDS Using Latent Class Analysis
Time frame: Conclusion of study. 4 weeks after randomization.
Comparative Specificity of the Physician, Conventional Diagnostics, and MDS Using Latent Class Analysis
Time frame: Conclusion of study. 4 weeks after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40653257Shantha JG, Moussa K, Laovirojjanakul W, Yeh S, Tsui E, Chen JL, Vitale AT, Shakoor A, Larochelle M, Niemeyer K, Mentreddy A, Livnat I, Safo M, Ao W, Choo C, Yan D, Zhong L, Chen C, Da Silva K, Reddy AK, Lee J, Sura A, Crowell EL, Qian Y, Sharon Y, Hinterwirth A, Porco T, Arnold BF, Gonzales J, Acharya NR, Lietman TM, Doan T; OPTICS Study Group. The Effect of Metagenomic Sequencing on Patient Clinical Outcomes for Intraocular Infections: A Multicenter Randomized Controlled Trial. Am J Ophthalmol. 2025 Nov;279:100-109. doi: 10.1016/j.ajo.2025.07.003. Epub 2025 Jul 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thuy Doan, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metagenomic Deep Sequencing (MDS) in people with Uveitis and Infectious Disease, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05286203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026; AzTrials last refreshed its copy on 28 Oct 2026.