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Completed

NCT Number: NCT04420962

Automated Quantitative Ulcer Analysis Study

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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Key information

Conditions

Keratitis Corneal Diseases Corneal Ulcer Eye Diseases Eye Infections Infections

Age range

15 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aravind Eye Care System, Madurai, Tamil Nadu, India

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Visual Acuity

Diagnostic Test

Best corrected visual acuity utilizing the Snellen method

Primary outcomes

  1. Visual Acuity

    Time frame: 90 day follow up

    Visual Acuity

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Official study title

Quantifying Microbial Keratitis to Predict Outcomes

Acronym: AQUA

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 9, 2020
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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