Automated Quantitative Ulcer Analysis Study (AQUA)

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.

Study Overview

• Status: Recruiting
• Conditions: Keratitis
• Intervention / Treatment: Diagnostic test: Visual Acuity

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 Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

• Study Contact: Name: Suzanne Winter, MS; Phone Number: 734-232-8185; Email: wsuzanne@med.umich.edu
• Study Contact Backup: Name: Maria A Woodward, MD, MS; Phone Number: 734-763-6967; Email: mariawood@med.umich.edu

Study Locations

• India
  • Tamil Nadu
    • Madurai, Tamil Nadu, India
      • Not yet recruiting
      • Aravind Eye Care System
      • Contact: N. Venkatesh Prajna, DO; Email: prajna@aravind.org
      • Principal Investigator: N. Venkatesh Prajna, DO
• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Recruiting
      • University of Michigan- Kellogg Eye Center
      • Contact: Suzanne Winter, MS; Phone Number: 734-232-8185; Email: wsuzanne@med.umich.edu
      • Contact: Maria A Woodward, MD, MS; Phone Number: 734-763-6967; Email: mariawoo@med.umich.edu
      • Principal Investigator: Maria A Woodward, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 99 years (Child, Adult, Older Adult)
• 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.

Description

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:

• Pregnancy
• Prior incisional corneal surgery
• No light perception vision
• Corneal perforation or impending perforation
• Inpatient status
• Institutional status
• Cognitively impaired
• Prisoner

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Microbial Keratitis; Presence of a bacteria or fungal keratitis with ≥ 2mm stromal infiltrate	Diagnostic test: Visual Acuity; Best corrected visual acuity utilizing the Snellen method
Viral or Inflammatory Keratitis; Non-infectious inflammatory, Viral, Acanthamoeba, or other forms of keratitis	Diagnostic test: Visual Acuity; Best corrected visual acuity utilizing the Snellen method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Visual Acuity	90 day follow up

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Eye Institute (NEI)
• Investigators: Principal Investigator: Maria A Woodward, MD, MS, University of Michigan

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2020
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Corneal Ulcer
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratitis
• Other Study ID Numbers: HUM00174923; R01EY031033 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No