Automated Quantitative Ulcer Analysis Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

124 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-23

Study Completion Date

2024-06-07

Brief Summary

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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.

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Detailed Description

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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

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Keratitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Microbial Keratitis

Presence of a bacteria or fungal keratitis with ≥ 2mm stromal infiltrate

Visual Acuity

Intervention Type DIAGNOSTIC_TEST

Best corrected visual acuity utilizing the Snellen method

Viral or Inflammatory Keratitis

Non-infectious inflammatory, Viral, Acanthamoeba, or other forms of keratitis

Visual Acuity

Intervention Type DIAGNOSTIC_TEST

Best corrected visual acuity utilizing the Snellen method

Interventions

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Visual Acuity

Best corrected visual acuity utilizing the Snellen method

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No