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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04420962
Other study ID # HUM00174923
Secondary ID R01EY031033
Status Recruiting
Phase
First received
Last updated
Start date July 23, 2020
Est. completion date July 2024

Study information

Verified date August 2023
Source University of Michigan
Contact Suzanne Winter, MS
Phone 734-232-8185
Email wsuzanne@med.umich.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 700
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 15 Years to 99 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Visual Acuity
Best corrected visual acuity utilizing the Snellen method

Locations

Country Name City State
India Aravind Eye Care System Madurai Tamil Nadu
United States University of Michigan- Kellogg Eye Center Ann Arbor Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan National Eye Institute (NEI)

Countries where clinical trial is conducted

United States,  India, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Acuity Visual Acuity 90 day follow up
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