Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II

Phase 3Active Not RecruitingNCT06271772

University of California, San Francisco60 enrolled

Overview

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: * Group 6, RB-PDT Plus Early Steroids: topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus RB-PDT * Group 7, Sham RB-PDT Plus Early Steroids: topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus sham RB-PDT

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Bacterial Keratitis

Interventions

Rose BengalDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Corneal ulcer that is smear positive and/or culture positive (within 24 hours) for typical bacteria (i.e. non-Nocardia or Myobacteria) * Moderate to severe vision loss, defined as Snellen visual acuity of 20/40 (6/12) or worse * Corneal thickness ≥350 µm, as measured on AS-OCT * Age over 18 years * Basic understanding of the study as determined by the physician * Commitment to return for follow up visits Exclusion Criteria: * Evidence of concomitant infection on exam, gram stain, or confocal microscopy (i.e. herpes, both bacteria and acanthamoeba on gram stain) * Impending or frank perforation at recruitment * Involvement of sclera at presentation * Presence of desmetocele at recruitment * Non-infectious or autoimmune keratitis * History of corneal transplantation * History of intraocular surgery within the last three months\* * Pinhole visual acuity worse than 20/200 in the unaffected eye * Participants who are decisionally and/or cognitively impaired

Outcomes

Primary Outcomes

Best Spectacle-Corrected Visual Acuity

Time frame: 6 months

Secondary Outcomes

Best Spectacle-Corrected Visual Acuity

Time frame: 3 Weeks, 3 Months, 12 Months

Scar size

Geometric mean

Time frame: 3 Weeks, 3 Months, 6 Months 12 Months

Scar depth