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| ID | Type | Description | Link |
|---|---|---|---|
| R01EY031033 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microbial Keratitis | Presence of a bacteria or fungal keratitis with ≥ 2mm stromal infiltrate |
| |
| Viral or Inflammatory Keratitis | Non-infectious inflammatory, Viral, Acanthamoeba, or other forms of keratitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visual Acuity | Diagnostic Test | Best corrected visual acuity utilizing the Snellen method |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Visual Acuity | 90 day follow up |
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Inclusion Criteria:
Exclusion Criteria:
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The subject population will be those that seek care at an ophthalmology clinic for microbial, non-infectious, viral, Acanthamoeba, or other keratitis and agree to participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Maria A Woodward, MD, MS | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan- Kellogg Eye Center | Ann Arbor | Michigan | 48105 | United States | ||
| Aravind Eye Care System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29256985 | Background | 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. | |
| 31307829 | Background | 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. |
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| ID | Term |
|---|---|
| D007634 | Keratitis |
| D003320 | Corneal Ulcer |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D015817 | Eye Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D014792 | Visual Acuity |
| ID | Term |
|---|---|
| D014787 | Vision Tests |
| D003941 | Diagnostic Techniques, Ophthalmological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Madurai |
| Tamil Nadu |
| India |
| 31977729 | Background | 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. |
| 32248131 | Background | 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. |
| 37267474 | Result | Lu MC, Deng C, Greenwald MF, Farsiu S, Prajna NV, Nallasamy N, Pawar M, Hart JN, Sr S, Kochar P, Selvaraj S, Levine H, Amescua G, Sepulveda-Beltran PA, Niziol LM, Woodward MA; and the AQUA Study Team. Automatic Classification of Slit-Lamp Photographs by Imaging Illumination. Cornea. 2024 Apr 1;43(4):419-424. doi: 10.1097/ICO.0000000000003318. Epub 2023 May 31. |
| 39929390 | Result | Woodward MA, Vogt EL, Niziol LM, Mian SI, Sugar A, Verkade A, Nallasamy N, Pawar M, Kang L, Miller KD, Winter S, Farsiu S, Prajna NV. Factors Associated with Vision Outcomes in Microbial Keratitis: A Multisite Prospective Cohort Study. Ophthalmology. 2025 Jul;132(7):830-841. doi: 10.1016/j.ophtha.2025.02.004. Epub 2025 Feb 8. |
| 41247284 | Derived | Vogt EL, Niziol LM, Yang Z, Wang Y, Pawar M, Dmitriev P, Gupta AS, Armenti ST, Hood CT, Shtein RM, Kipley MM, Lee MC, Sumithra SR, Thulukanam M, Kochar P, Selvaraj S, Redd TK, Prajna NV, Farsiu S, Woodward MA. Association of Deep Learning Imaging Algorithm Measures of Microbial Keratitis With Vision Outcomes. Cornea. 2025 Oct 29:10.1097/ICO.0000000000004029. doi: 10.1097/ICO.0000000000004029. Online ahead of print. |
| 39661074 | Derived | Lee MC, Vogt EL, Hicks PM, Pawar M, Lu MC, Niziol LM, Terek DA, Nallasamy N, Hakim FE, Woodward MA. Social Risk Factors Associated With Microbial Keratitis. Cornea. 2026 Jan 1;45(1):21-28. doi: 10.1097/ICO.0000000000003766. Epub 2024 Dec 10. |
| D009799 | Ocular Physiological Phenomena |