Status:
TERMINATED
Evaluating the Use of ProKera Plus® in the Management of Bacterial Corneal Ulcers
Lead Sponsor:
University of Arkansas
Conditions:
Bacterial Corneal Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study design is a prospective, randomized, controlled interventional study to compare the outcome of ProKera Plus® with conventional treatment in patients with vision-threatening bacterial corneal...
Detailed Description
Bacterial keratitis is a serious bacterial infection of the cornea, usually caused by a persistent epithelial defect or ulcer that can lead to permanent vision loss from corneal scarring, perforation ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Subjects 18 years of age or older, all sexes and races
- Willing to sign a written informed consent to participate
- Corneal ulcer criteria: at least 3mm in diameter, opacification located within 3mm of visual axis, infiltrate occupying at least 50% of the corneal thickness, moderate AC cell reaction, clinical picture consistent with bacterial infection later confirmed by culture and gram stain.
Exclusion
- History of Immunodeficiency
- History of connective tissue disorders or severe atopic disease
- History of chemical eye injuries
- History of known limbal stem cell deficiency
- History of neurotrophic keratopathy
- History of recent eye surgery, or glaucoma surgery with bleb or drainage tube
- Risk factors and clinical appearance consistent with fungal keratitis
Key Trial Info
Start Date :
November 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04850313
Start Date
November 9 2021
End Date
September 30 2022
Last Update
July 7 2023
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205