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Automated Quantitative Ulcer Analysis Study (AQUA)

University of Michigan logo

University of Michigan

Status

Completed

Conditions

Keratitis

Treatments

Diagnostic Test: Visual Acuity

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT04420962
HUM00174923
R01EY031033 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

124 patients

Sex

All

Ages

15 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

124 participants in 2 patient groups

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

Trial contacts and locations

2

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Central trial contact

Maria A Woodward, MD, MS; Suzanne Winter, MS

Data sourced from clinicaltrials.gov

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