Automated Quantitative Ulcer Analysis Study

Recruiting

• Conditions: Keratitis
• Interventions: Diagnostic Test: Visual Acuity

• Registration Number: NCT04420962
• Lead Sponsor: University of Michigan

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-09
• Study Start: 2020-07-23
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-01
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Microbial Keratitis	Visual Acuity	Presence of a bacteria or fungal keratitis with ≥ 2mm stromal infiltrate
Viral or Inflammatory Keratitis	Visual Acuity	Non-infectious inflammatory, Viral, Acanthamoeba, or other forms of keratitis

Primary Outcome Measures

Name	Time	Method
Visual Acuity	90 day follow up	Visual Acuity

Trial Locations

Locations (2)

Aravind Eye Care System; 🇮🇳 Madurai, Tamil Nadu, India

University of Michigan- Kellogg Eye Center; 🇺🇸 Ann Arbor, Michigan, United States