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| Name | Class |
|---|---|
| Stanford University | OTHER |
| Aravind Eye Care System | OTHER |
| Federal University of São Paulo | OTHER |
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Rose Bengal Electromagnetic Activation with Green light for Infection Reduction II (REAGIR II) is a randomized, double-masked feasibility study. The purpose of this study is to determine differences in 6-month visual acuity between medical antimicrobial treatments alone versus antimicrobial treatment plus cross-linking with rose Bengal (RB-PDT).
Patients presenting to one of the Aravind Eye Hospitals in India or to the Federal University of São Paulo ophthalmology clinic in Brazil with smear-positive and/or culture positive typical (I.e. non-Nocardia or Mycobacteria) bacterial corneal ulcers and moderate to severe vision loss, defined as Snellen visual acuity of 20/40 of worse, will be eligible for inclusion. Those who agree to participate will be randomized to one of two treatment groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RB-PDT Plus Early Steroids | Experimental |
| |
| Sham RB-PDT Plus Early Steroids | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Difluprednate Ophthalmic | Drug | Difluprednate 0.05% is a corticosteroid used to reduce inflammation in the eye. Participants will receive one drop of 0.05% difluprednate four times daily beginning 24 hours after the initiation of antibiotics for 1 week, decreased by 1 drop weekly for a total of 4 weeks of steroid therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Best Spectacle-Corrected Visual Acuity | Best Spectacle-Corrected Visual Acuity | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Best Spectacle-Corrected Visual Acuity | Best Spectacle-Corrected Visual Acuity | 3 Weeks, 3 Months, 12 Months |
| Scar size | Geometric mean |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Rose-Nussbaumer, MD | Stanford University | Principal Investigator |
| Thomas Lietman, MD | University of California, San Francisco | Principal Investigator |
| Nicole Varnado, MPH | Stanford University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of São Paulo | São Paulo | Brazil | ||||
| Aravind Eye Care System |
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| ID | Term |
|---|---|
| D012395 | Rose Bengal |
| D000094504 | Corneal Cross-Linking |
| ID | Term |
|---|---|
| D005452 | Fluoresceins |
| D013141 | Spiro Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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|
| Rose Bengal | Drug | Study participants receive RB-PDT within 48 hours of randomization. All participants will receive a 30-minute loading dose of topical Rose Bengal (0.1% RB in 0.9% sodium chloride) which will be applied in 3-minute intervals to the de-epithelialized cornea. This will be followed by irradiation with a 6mW/cm2 custom-made green LED source for 15 minutes (5.4J/cm2). Repeat cornea culture will be collected within 24 hours after the procedure. |
|
|
| Moxifloxacin Ophthalmic | Drug | Topical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is a standard therapy for bacterial keratitis. |
|
| 3 Weeks, 3 Months, 6 Months 12 Months |
| Scar depth | Geometric mean | 3 Weeks, 3 Months, 6 Months 12 Months |
| Adverse Events | Adverse Events | 12 Months |
| Madurai |
| Tamil Nadu |
| India |
| D009930 |
| Organic Chemicals |
| D014966 | Xanthenes |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010778 | Photochemotherapy |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |