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CompletedNCT04420962AQUAUpdated May 2, 2025

Automated Quantitative Ulcer Analysis Study

An observational study in Keratitis, sponsored by University of Michigan. Completed at 2 sites in 2 countries. Open to participants aged 15 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-05-02.

Sponsored by University of Michigan · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
124
Ages
15 Years to 99 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Keratitis

Keywords

  • Corneal Ulcer
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In context

Keratitis

108 studies on the registry are indexed under Keratitis; 19 are open to participants now.

This study's enrollment of 124 is above the median of 105 across 31 observational studies indexed under Keratitis.

Browse Keratitis studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.

Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Cases- microbial keratitis (bacterial or fungal) with presence of ≥2mm stromal infiltrate
  • Controls- Inflammatory, viral, Acanthamoeba, or other keratitis

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Prior incisional corneal surgery
  • No light perception vision
  • Corneal perforation or impending perforation
  • Inpatient status
  • Institutional status
  • Cognitively impaired
  • Prisoner
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
124 participants (actual)
Patient registry
No

Groups and cohorts

  • Microbial Keratitis

    Presence of a bacteria or fungal keratitis with ≥ 2mm stromal infiltrate

    Diagnostic Test: Visual Acuity

  • Viral or Inflammatory Keratitis

    Non-infectious inflammatory, Viral, Acanthamoeba, or other forms of keratitis

    Diagnostic Test: Visual Acuity

Interventions

  • Diagnostic testVisual Acuity

    Best corrected visual acuity utilizing the Snellen method

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What researchers measure

Primary outcomes

  1. Visual Acuity

    Visual Acuity

    Time frame: 90 day follow up

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Study locations

2 sites
  • University of Michigan- Kellogg Eye Center
    Ann Arbor, Michigan 48105, United States
  • Aravind Eye Care System
    Madurai, Tamil Nadu, India
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References and documents

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 29256985 ↗
  • Maganti 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 31307829 ↗
  • Kriegel 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 31977729 ↗
  • Loo 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 32248131 ↗
  • Lu 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 37267474 ↗
  • Woodward 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 39929390 ↗
  • Vogt 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 41247284 ↗
  • Lee 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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04420962
Responsible party
Maria Woodward (Assistant Professor, University of Michigan) — Principal investigator
First posted
Jun 9, 2020
Start date
Jul 23, 2020
Primary completion
Jun 7, 2024
Completion
Jun 7, 2024
Last update
May 2, 2025

Study contacts

Maria A Woodward, MD, MS
principal investigator · University of Michigan

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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