Automated Quantitative Ulcer Analysis Study

Keratitis Clinical Trial

— AQUA  

Official title:

Quantifying Microbial Keratitis to Predict Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04420962
• Other study ID #: HUM00174923
• Secondary ID: R01EY031033
• Status: Recruiting
• Start date: July 23, 2020
• Est. completion date: July 2024

Study information

• Verified date: August 2023
• Source: University of Michigan
• Contact: Suzanne Winter, MS
• Phone: 734-232-8185
• Email: wsuzanne[@]med.umich.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Keratitis

Intervention

Diagnostic Test:
• Visual Acuity
Best corrected visual acuity utilizing the Snellen method

Locations

Country	Name	City	State
India	Aravind Eye Care System	Madurai	Tamil Nadu
United States	University of Michigan- Kellogg Eye Center	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Eye Institute (NEI)

Countries where clinical trial is conducted

United States,  India, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	Visual Acuity	90 day follow up