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Automated Quantitative Ulcer Analysis Study

Quantifying Microbial Keratitis to Predict Outcomes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04420962
Acronym
AQUA
Enrollment
124
Registered
2020-06-09
Start date
2020-07-23
Completion date
2024-06-07
Last updated
2025-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratitis

Keywords

Corneal Ulcer

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.

Interventions

DIAGNOSTIC_TESTVisual Acuity

Best corrected visual acuity utilizing the Snellen method

Sponsors

National Eye Institute (NEI)
CollaboratorNIH
University of Michigan
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Acuity90 day follow upVisual Acuity

Countries

India, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026