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Clinical Trials/NCT04420962
NCT04420962
Completed
Not Applicable

Quantifying Microbial Keratitis to Predict Outcomes

University of Michigan2 sites in 2 countries124 target enrollmentJuly 23, 2020
ConditionsKeratitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Keratitis
Sponsor
University of Michigan
Enrollment
124
Locations
2
Primary Endpoint
Visual Acuity
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 23, 2020
End Date
June 7, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maria Woodward

Assistant Professor

University of Michigan

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

Outcomes

Primary Outcomes

Visual Acuity

Time Frame: 90 day follow up

Visual Acuity

Study Sites (2)

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