KeratitisAQUANCT04420962
Automated Quantitative Ulcer Analysis Study
An observational study of Keratitis, run by University of Michigan at 2 sites in 2 countries.
Trial summary
This is a multiple site observational study that will review patient features (clinical and morphologic) over a 90 day period during care of participants with microbial keratitis with presence of clinically significant ≥2mm stromal infiltrate compared with participants with other forms of keratitis. Read more about this study
- Who is it for?
- Ages 15 to 99 years
- Conditions the study is for
- Keratitis
- What is being tested?
- Visual Acuity
- How many people
- 124 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Jul 2020to 7 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The subject population will be those that seek care at an ophthalmology clinic for microbial, non-infectious, viral, Acanthamoeba, or other keratitis and agree to participate in the study.
Who may be able to join
- Cases- microbial keratitis (bacterial or fungal) with presence of clinically significant ≥2mm stromal infiltrate
- Controls- Inflammatory, viral, Acanthamoeba, or other keratitis
Who cannot join
- Pregnancy
- Prior incisional corneal surgery
- No light perception vision
- Corneal perforation or impending perforation
- Inpatient status
- Institutional status
- Cognitively impaired
- Prisoner
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Michigan- Kellogg Eye Center
Ann Arbor, Michigan, 48105
About this study
Official title: Quantifying Microbial Keratitis to Predict Outcomes
This is a multiple site observational study that will review patient features (clinical and morphologic) over a 90 day period during care of participants with microbial keratitis with presence of clinically significant ≥2mm stromal infiltrate compared with participants with other forms of keratitis.
Read the detailed description
The primary objective of this study is to determine associations between participant features (clinical and morphologic) and best corrected visual acuity at Day 90. Imaging, focused on slit lamp photography and supplemented by other imaging markers will be collected for review. A medical record review at one year following participants initial visit will record any corneal procedure and visual acuity testing that occurred during this window. Participants will complete demographic, clinical, and standardized health surveys.
- Conditions
- Keratitis
- Being tested
- Visual Acuity
- Keywords
- Corneal Ulcer
- Medical subject headings
- Keratitis, Corneal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual AcuityDiagnostic test
Best corrected visual acuity utilizing the Snellen method
| Study group | Role | What they receive |
|---|---|---|
| Microbial Keratitis | Presence of a bacteria or fungal keratitis with ≥ 2mm stromal infiltrate Receives: Diagnostic Test: Visual Acuity | |
| Viral or Inflammatory Keratitis | Non-infectious inflammatory, Viral, Acanthamoeba, or other forms of keratitis Receives: Diagnostic Test: Visual Acuity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Visual Acuity
Measured: 90 day follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start23 Jul 2020
- Primary completion7 Jun 2024
- Study completion7 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for KeratitisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, Maria Woodward, University of Michigan
- Investigators
- Maria A Woodward, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420962
- Sponsor's protocol ID
- HUM00174923
- Other IDs
- R01EY031033
- Acronym
- AQUA
- Status last verified
- Apr 2025
- First submitted
- 4 Jun 2020
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patel TP, Prajna NV, Farsiu S, Valikodath NG, Niziol LM, Dudeja L, Kim KH, Woodward MA. Novel Image-Based Analysis for Reduction of Clinician-Dependent Variability in Measurement of the Corneal Ulcer Size. Cornea. 2018 Mar;37(3):331-339. doi: 10.1097/ICO.0000000000001488.
PubMed 29256985Maganti N, Tan H, Niziol LM, Amin S, Hou A, Singh K, Ballouz D, Woodward MA. Natural Language Processing to Quantify Microbial Keratitis Measurements. Ophthalmology. 2019 Dec;126(12):1722-1724. doi: 10.1016/j.ophtha.2019.06.003. Epub 2019 Jun 11.
PubMed 31307829Kriegel MF, Huang J, Ashfaq HA, Niziol LM, Preethi M, Tan H, Tuohy MM, Patel TP, Prajna V, Woodward MA. Algorithm Variability in Quantification of Epithelial Defect Size in Microbial Keratitis Images. Cornea. 2020 May;39(5):628-633. doi: 10.1097/ICO.0000000000002258.
PubMed 31977729Loo J, Kriegel MF, Tuohy MM, Kim KH, Prajna V, Woodward MA, Farsiu S. Open-Source Automatic Segmentation of Ocular Structures and Biomarkers of Microbial Keratitis on Slit-Lamp Photography Images Using Deep Learning. IEEE J Biomed Health Inform. 2021 Jan;25(1):88-99. doi: 10.1109/JBHI.2020.2983549. Epub 2021 Jan 5.
PubMed 32248131Lu MC, Deng C, Greenwald MF, Farsiu S, Prajna NV, Nallasamy N, Pawar M, Hart JN, Sr S, Kochar P, Selvaraj S, Levine H, Amescua G, Sepulveda-Beltran PA, Niziol LM, Woodward MA; and the AQUA Study Team. Automatic Classification of Slit-Lamp Photographs by Imaging Illumination. Cornea. 2024 Apr 1;43(4):419-424. doi: 10.1097/ICO.0000000000003318. Epub 2023 May 31.
PubMed 37267474Woodward MA, Vogt EL, Niziol LM, Mian SI, Sugar A, Verkade A, Nallasamy N, Pawar M, Kang L, Miller KD, Winter S, Farsiu S, Prajna NV. Factors Associated with Vision Outcomes in Microbial Keratitis: A Multisite Prospective Cohort Study. Ophthalmology. 2025 Jul;132(7):830-841. doi: 10.1016/j.ophtha.2025.02.004. Epub 2025 Feb 8.
PubMed 39929390Vogt EL, Niziol LM, Yang Z, Wang Y, Pawar M, Dmitriev P, Gupta AS, Armenti ST, Hood CT, Shtein RM, Kipley MM, Lee MC, Sumithra SR, Thulukanam M, Kochar P, Selvaraj S, Redd TK, Prajna NV, Farsiu S, Woodward MA. Association of Deep Learning Imaging Algorithm Measures of Microbial Keratitis With Vision Outcomes. Cornea. 2025 Oct 29:10.1097/ICO.0000000000004029. doi: 10.1097/ICO.0000000000004029. Online ahead of print.
PubMed 41247284Lee MC, Vogt EL, Hicks PM, Pawar M, Lu MC, Niziol LM, Terek DA, Nallasamy N, Hakim FE, Woodward MA. Social Risk Factors Associated With Microbial Keratitis. Cornea. 2026 Jan 1;45(1):21-28. doi: 10.1097/ICO.0000000000003766. Epub 2024 Dec 10.
PubMed 39661074
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Microbial Keratitis to Predict Outcomes
- ClinicalTrials.gov ID
- NCT04420962
- Acronym / sponsor ID
- AQUA / HUM00174923
- Conditions
- Keratitis
- Keywords
- Corneal Ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 7 Jun 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
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 multiple site observational study that will review patient features (clinical and morphologic) over a 90 day period during care of participants with microbial keratitis with presence of clinically significant ≥2mm stromal infiltrate compared with participants with other forms of keratitis.
Detailed description
The primary objective of this study is to determine associations between participant features (clinical and morphologic) and best corrected visual acuity at Day 90. Imaging, focused on slit lamp photography and supplemented by other imaging markers will be collected for review. A medical record review at one year following participants initial visit will record any corneal procedure and visual acuity testing that occurred during this window. Participants will complete demographic, clinical, and standardized health surveys.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microbial Keratitis | – | Diagnostic Test: Visual AcuityPresence of a bacteria or fungal keratitis with ≥ 2mm stromal infiltrate |
| Viral or Inflammatory Keratitis | – | Diagnostic Test: Visual AcuityNon-infectious inflammatory, Viral, Acanthamoeba, or other forms of keratitis |
Who may qualify
- Ages
- 15 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The subject population will be those that seek care at an ophthalmology clinic for microbial, non-infectious, viral, Acanthamoeba, or other keratitis and agree to participate in the study.
Key inclusion criteria (2 listed)
- Cases- microbial keratitis (bacterial or fungal) with presence of clinically significant ≥2mm stromal infiltrate
- Controls- Inflammatory, viral, Acanthamoeba, or other keratitis
Key exclusion criteria (8 listed)
- Pregnancy
- Prior incisional corneal surgery
- No light perception vision
- Corneal perforation or impending perforation
- Inpatient status
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 |
|---|---|---|
| Visual AcuityBest corrected visual acuity utilizing the Snellen method | Diagnostic test | Microbial Keratitis, Viral or Inflammatory Keratitis |
Primary outcome
Visual Acuity
Time frame: 90 day follow up
Visual Acuity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Background: PubMed 29256985Patel TP, Prajna NV, Farsiu S, Valikodath NG, Niziol LM, Dudeja L, Kim KH, Woodward MA. Novel Image-Based Analysis for Reduction of Clinician-Dependent Variability in Measurement of the Corneal Ulcer Size. Cornea. 2018 Mar;37(3):331-339. doi: 10.1097/ICO.0000000000001488.
- Background: PubMed 31307829Maganti N, Tan H, Niziol LM, Amin S, Hou A, Singh K, Ballouz D, Woodward MA. Natural Language Processing to Quantify Microbial Keratitis Measurements. Ophthalmology. 2019 Dec;126(12):1722-1724. doi: 10.1016/j.ophtha.2019.06.003. Epub 2019 Jun 11.
- Background: PubMed 31977729Kriegel MF, Huang J, Ashfaq HA, Niziol LM, Preethi M, Tan H, Tuohy MM, Patel TP, Prajna V, Woodward MA. Algorithm Variability in Quantification of Epithelial Defect Size in Microbial Keratitis Images. Cornea. 2020 May;39(5):628-633. doi: 10.1097/ICO.0000000000002258.
- Background: PubMed 32248131Loo J, Kriegel MF, Tuohy MM, Kim KH, Prajna V, Woodward MA, Farsiu S. Open-Source Automatic Segmentation of Ocular Structures and Biomarkers of Microbial Keratitis on Slit-Lamp Photography Images Using Deep Learning. IEEE J Biomed Health Inform. 2021 Jan;25(1):88-99. doi: 10.1109/JBHI.2020.2983549. Epub 2021 Jan 5.
- Results publication: PubMed 37267474Lu MC, Deng C, Greenwald MF, Farsiu S, Prajna NV, Nallasamy N, Pawar M, Hart JN, Sr S, Kochar P, Selvaraj S, Levine H, Amescua G, Sepulveda-Beltran PA, Niziol LM, Woodward MA; and the AQUA Study Team. Automatic Classification of Slit-Lamp Photographs by Imaging Illumination. Cornea. 2024 Apr 1;43(4):419-424. doi: 10.1097/ICO.0000000000003318. Epub 2023 May 31.
- Results publication: PubMed 39929390Woodward MA, Vogt EL, Niziol LM, Mian SI, Sugar A, Verkade A, Nallasamy N, Pawar M, Kang L, Miller KD, Winter S, Farsiu S, Prajna NV. Factors Associated with Vision Outcomes in Microbial Keratitis: A Multisite Prospective Cohort Study. Ophthalmology. 2025 Jul;132(7):830-841. doi: 10.1016/j.ophtha.2025.02.004. Epub 2025 Feb 8.
- Derived from this study: PubMed 41247284Vogt EL, Niziol LM, Yang Z, Wang Y, Pawar M, Dmitriev P, Gupta AS, Armenti ST, Hood CT, Shtein RM, Kipley MM, Lee MC, Sumithra SR, Thulukanam M, Kochar P, Selvaraj S, Redd TK, Prajna NV, Farsiu S, Woodward MA. Association of Deep Learning Imaging Algorithm Measures of Microbial Keratitis With Vision Outcomes. Cornea. 2025 Oct 29:10.1097/ICO.0000000000004029. doi: 10.1097/ICO.0000000000004029. Online ahead of print.
- Derived from this study: PubMed 39661074Lee MC, Vogt EL, Hicks PM, Pawar M, Lu MC, Niziol LM, Terek DA, Nallasamy N, Hakim FE, Woodward MA. Social Risk Factors Associated With Microbial Keratitis. Cornea. 2026 Jan 1;45(1):21-28. doi: 10.1097/ICO.0000000000003766. Epub 2024 Dec 10.
- 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.
Maria A Woodward, MD, MS principal investigator
University of Michigan
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratitis, run by University of Michigan at 2 sites in 2 countries.
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 2 inclusion and 8 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 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Acuity (time frame: 90 day follow up). 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 NCT04420962, which also lists 8 linked publications.
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 2 May 2025.