Evaluating the Use of ProKera Plus® in the Management of Bacterial Corneal Ulcers
Bacterial Corneal Ulcer
About this trial
This is an interventional treatment trial for Bacterial Corneal Ulcer
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
- 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
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Conventional Treatment
ProKera Plus® Treatment
Corneal ulcer scraping sent for microbial culture Admission to the hospital for initiation of fortified vancomycin 25mg/mL every 1 hour alternating with fortified tobramycin 15mg/mL every 1 hour, preservative free artificial tears every 2 hours, and doxycycline 100mg twice daily. After 48 hours of conventional treatment, consent will be obtained regarding the use of experimental treatment with ProKera Plus® versus continuing conventional method of treatment
1. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer