NCT04420962

Automated Quantitative Ulcer Analysis Study

Quantifying Microbial Keratitis to Predict Outcomes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 124 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 15 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Keratitis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Visual Acuity	Best corrected visual acuity utilizing the Snellen method

Timeline

• Start date: 2020-07-23
• Primary completion: 2024-06-07
• Completion: 2024-06-07
• First posted: 2020-06-09
• Last updated: 2025-05-02

Locations

2 sites across 2 countries: United States, India