Clinical trial NCT04420962: Automated Quantitative Ulcer Analysis Study
Official title: Quantifying Microbial Keratitis to Predict Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratitis
Keywords: Corneal Ulcer
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2020-06-09
Enrollment: 124
Sex: ALL
Minimum age (years): 15
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Acuity
timeFrame: 90 day follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan- Kellogg Eye Center
state: Michigan
city: Madurai
country: India
facility: Aravind Eye Care System
state: Tamil Nadu
Study officials:
affiliation: University of Michigan
name: Maria A Woodward, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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 Feb 8:S0161-6420(25)00100-9. doi: 10.1016/j.ophtha.2025.02.004. Online ahead of print.