Automated Quantitative Ulcer Analysis Study

NCT04420962 | Completed DMC

• 2 other identifiers: HUM00174923R01EY031033
• Study Type: observational
• Target: 124
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Keratitis

Keywords

Corneal Ulcer

Outcome Measures

Primary Outcomes (1)

• Visual Acuity

  Visual Acuity

  90 day follow up

Study Arms (2)

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

Visual Acuity DIAGNOSTIC_TEST

Best corrected visual acuity utilizing the Snellen method

Microbial Keratitis; Viral or Inflammatory Keratitis

Eligibility Criteria

• Age: 15 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead
• National Eye Institute (NEI): collaborator

Study Sites (2)

University of Michigan- Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

Location

Aravind Eye Care System

Madurai, Tamil Nadu, India

Location

Related Publications (8)

• 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.

  PMID: 29256985 BACKGROUND

• 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.

  PMID: 31307829 BACKGROUND

• 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.

  PMID: 31977729 BACKGROUND

• 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.

  PMID: 32248131 BACKGROUND

• 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.

  PMID: 37267474 BACKGROUND

• 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.

  PMID: 39929390 BACKGROUND

• 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. doi: 10.1097/ICO.0000000000004029. Online ahead of print.

  PMID: 41247284 DERIVED

• 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.

  PMID: 39661074 DERIVED

MeSH Terms

Conditions

Keratitis; Corneal Ulcer

Interventions

Visual Acuity

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Eye Infections; Infections

Intervention Hierarchy (Ancestors)

Vision Tests; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Ocular Physiological Phenomena

Study Officials

• Maria A Woodward, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: July 23, 2020
• Primary Completion: June 7, 2024
• Study Completion: June 7, 2024
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1); US (1)