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RecruitingNCT04420962AQUAUpdated Sep 1, 2023

Automated Quantitative Ulcer Analysis Study

An observational study in Keratitis, sponsored by University of Michigan. Recruiting at 2 sites in 2 countries. Open to participants aged 15 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-09-01.

Sponsored by University of Michigan · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
700
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

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Keywords

  • Corneal Ulcer
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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.

Inclusion criteria

  • Cases- microbial keratitis (bacterial or fungal) with presence of clinically significant ≥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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
700 participants (estimated)
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

1 of 2 sites recruiting
  • University of Michigan- Kellogg Eye Center
    Ann Arbor, Michigan 48105, United States
    Recruiting
  • Aravind Eye Care System
    Madurai, Tamil Nadu, India
    • N. Venkatesh Prajna, DO · Contact · prajna@aravind.org
    • N. Venkatesh Prajna, DO · Principal investigator
    Not yet recruiting
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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 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT04420962
Lead sponsor
University of Michigan
Collaborators
National Eye Institute (NEI)
Responsible party
Maria Woodward (Assistant Professor, University of Michigan) — Principal investigator
First posted
Jun 9, 2020
Start date
Jul 23, 2020
Primary completion
Jul 2024 (estimated)
Completion
Jul 2024 (estimated)
Last update
Sep 1, 2023

Study contacts

Suzanne Winter, MS
Contact
wsuzanne@med.umich.edu
734-232-8185
Maria A Woodward, MD, MS
Contact
mariawood@med.umich.edu
734-763-6967
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 ↗

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