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Amniotic Membrane
ProProKera Plus® for Bacterial Corneal Ulcers
N/A
Waitlist Available
Led By David Warrner, MD
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects 18 years of age or older, all sexes and races
Willing to sign a written informed consent to participate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180-day follow-up plus or minus 14 days
Awards & highlights
Study Summary
This trial will compare the outcomes of a new treatment for bacterial corneal ulcers to the conventional treatment. The study will be conducted at the University of Arkansas Medical Sciences in two phases.
Eligible Conditions
- Bacterial Corneal Ulcers
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 180-day follow-up plus or minus 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180-day follow-up plus or minus 14 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Visual Acuity - Visit 1
Visual Recovery - Visit 2
Visual Recovery - Visit 3
+2 moreSecondary outcome measures
Corneal Opacity Size - Visit 1
Corneal Opacity Size - Visit 3
Corneal Opacity Thinning-Visit 1
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ProKera Plus® TreatmentExperimental Treatment1 Intervention
1. Experimental Treatment Arm , ProKera Plus® will be placed in the eye with the corneal ulcer
Group II: Conventional TreatmentActive Control1 Intervention
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
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Who is running the clinical trial?
University of ArkansasLead Sponsor
483 Previous Clinical Trials
148,524 Total Patients Enrolled
David Warrner, MDPrincipal InvestigatorUniversity Of Arkansas For Medical Sciences, Jones Eye Institute
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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