Steroids for Corneal Ulcers Trial
Condition: Corneal Ulcer; Eye Infections, Bacterial
MeSH terms: Bacterial Infections; Corneal Ulcer; Eye Infections; Eye Infections, Bacterial; Ulcer
Intervention: Antibiotics; Topical corticosteroid; Placebo
Intervention description: moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization; prednisolone phosphate 1% with preservative four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week; 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week
Intervention MeSH terms: Anti-Bacterial Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 500.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Bacterial Infections; Eye Diseases; Bacterial Keratitis; Visual Acuity

Summary:

      The purpose of this study is to determine whether adding topical steroids improves the
      outcomes of bacterial corneal ulcers, especially visual acuity.
    

Eligibility criteria:

        Inclusion Criteria

        At Presentation:

          -  Presence of a corneal ulcer at presentation

        At Enrollment:

          -  Presence of bacteria on blood or chocolate agar culture

          -  Antibiotic given for > 48 hours

          -  The patient must be able to verbalize a basic understanding of the study after it is
             explained to the patient, as determined by physician examiner. This understanding must
             include a commitment to return for f/u visits.

          -  Appropriate consent

        Exclusion Criteria

        At Presentation:

          -  Overlying epithelial defect < 0.75 mm at its greatest width at presentation

          -  Corneal perforation or impending perforation

          -  Evidence of fungus on KOH, Giemsa at time of presentation

          -  Evidence of acanthamoeba by stain

          -  Evidence of herpetic keratitis by history or exam

          -  Corneal scar not easily distinguishable from current ulcer

          -  Use of a topical steroid in the affected eye during the course of the present ulcer,
             including use after the symptoms of the ulcer started but before presentation

          -  Use of systemic prednisolone during the course of the present ulcer

          -  Age less than 16 years (before 16th birthday)

          -  Bilateral ulcers

          -  Previous penetrating keratoplasty

          -  Pregnancy (by history or urine test)

          -  Immediate steroid use necessary due to surgery or other condition

        At Enrollment:

          -  Evidence of fungus on culture at time of enrollment

          -  Absence of bacteria on blood or chocolate agar culture

          -  Best spectacle-corrected vision worse than 6/60 in the fellow eye

          -  Corneal perforation or descemetocele

          -  Known allergy to study medications (steroid or preservative)

          -  No light perception in the affected eye

          -  Not willing to come to follow-up visits

          -  Not willing to participate