AQUA: Automated Quantitative Ulcer Analysis Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Microbial Keratitis Presence of a bacteria or fungal keratitis with ≥ 2mm stromal infiltrate |
Diagnostic Test: Visual Acuity
Best corrected visual acuity utilizing the Snellen method
|
| Viral or Inflammatory Keratitis Non-infectious inflammatory, Viral, Acanthamoeba, or other forms of keratitis |
Diagnostic Test: Visual Acuity
Best corrected visual acuity utilizing the Snellen method
|
Outcome Measures
Primary Outcome Measures
- Visual Acuity [90 day follow up]
Visual Acuity
Eligibility Criteria
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
-
Prisoner
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan- Kellogg Eye Center | Ann Arbor | Michigan | United States | 48105 |
| 2 | Aravind Eye Care System | Madurai | Tamil Nadu | India |
Sponsors and Collaborators
- University of Michigan
- National Eye Institute (NEI)
Investigators
- Principal Investigator: Maria A Woodward, MD, MS, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Kriegel MF, Huang J, Ashfaq HA, Niziol LM, Preethi M, Tan H, Tuohy MM, Patel TP, Prajna V, Woodward MA. Algorithm Variability in Quantification of Epithelial Defect Size in Microbial Keratitis Images. Cornea. 2020 May;39(5):628-633. doi: 10.1097/ICO.0000000000002258.
- Loo J, Kriegel MF, Tuohy MM, Kim KH, Prajna V, Woodward MA, Farsiu S. Open-Source Automatic Segmentation of Ocular Structures and Biomarkers of Microbial Keratitis on Slit-Lamp Photography Images Using Deep Learning. IEEE J Biomed Health Inform. 2021 Jan;25(1):88-99. doi: 10.1109/JBHI.2020.2983549. Epub 2021 Jan 5.
- Maganti N, Tan H, Niziol LM, Amin S, Hou A, Singh K, Ballouz D, Woodward MA. Natural Language Processing to Quantify Microbial Keratitis Measurements. Ophthalmology. 2019 Dec;126(12):1722-1724. doi: 10.1016/j.ophtha.2019.06.003. Epub 2019 Jun 11.
- Patel TP, Prajna NV, Farsiu S, Valikodath NG, Niziol LM, Dudeja L, Kim KH, Woodward MA. Novel Image-Based Analysis for Reduction of Clinician-Dependent Variability in Measurement of the Corneal Ulcer Size. Cornea. 2018 Mar;37(3):331-339. doi: 10.1097/ICO.0000000000001488.
- HUM00174923
- R01EY031033