Steroids and Cross-linking for Ulcer Treatment
- Conditions
- Keratitis Bacterial
- Interventions
- Other: Topical Placebo
- Registration Number
- NCT04097730
- Lead Sponsor
- Thomas M. Lietman
- Brief Summary
Steroids and Cross-linking for Ulcer Treatment (SCUT II) is an international, randomized, double-masked, clinical trial. The purpose of this study is to determine differences in 6-month visual acuity between medical antimicrobial treatments alone versus antimicrobial treatment plus collagen cross-linking (CXL), as well as to further evaluate findings from subgroup analyses of SCUT. Patients presenting to the Aravind Eye Care System (India), Kaiser Permanente Northern California (USA), or the University of California, San Francisco (USA) 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 or worse, will be eligible for inclusion. Those who agree to participate will be randomized to one of three treatment groups:
Group 1: Standard therapy, topical 0.5% moxifloxacin plus topical placebo plus sham CXL Group 2: Early steroids, topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus sham CXL Group 3: CXL plus early steroids, topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus CXL
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 280
- Corneal ulcer that is smear positive and/or culture positive (within 24 hours) for typical bacteria (i.e. non-Nocardia or Mycobacteria)
- 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
- Evidence of concomitant infection on exam, gram stain, or confocal microscopy (i.e. herpes, both bacteria and acanthameoba on gram stain)
- Impending or frank perforation at recruitment
- Involvement of sclera at presentation
- Non-infectious or autoimmune keratitis
- History of corneal transplantation or recent intraocular surgery
- Pinhole visual acuity worse than 20/200 in the unaffected eye
- Participants who are decisionally and/or cognitively impaired
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Therapy Riboflavin Ophthalmic Participants in this arm will receive topical 0.5% moxifloxacin plus topical placebo plus sham corneal cross-linking. Standard Therapy Topical Placebo Participants in this arm will receive topical 0.5% moxifloxacin plus topical placebo plus sham corneal cross-linking. Early Steroids Difluprednate Ophthalmic Participants in this arm will receive topical 0.5% moxifloxacin plus topical steroids plus sham corneal cross-linking. Cross-Linking plus Early Steroids Moxifloxacin Ophthalmic Participants in this group will receive topical 0.5% moxifloxacin plus topical steroids plus corneal cross-linking. Cross-Linking plus Early Steroids Difluprednate Ophthalmic Participants in this group will receive topical 0.5% moxifloxacin plus topical steroids plus corneal cross-linking. Standard Therapy Moxifloxacin Ophthalmic Participants in this arm will receive topical 0.5% moxifloxacin plus topical placebo plus sham corneal cross-linking. Early Steroids Moxifloxacin Ophthalmic Participants in this arm will receive topical 0.5% moxifloxacin plus topical steroids plus sham corneal cross-linking. Cross-Linking plus Early Steroids Riboflavin Ophthalmic Participants in this group will receive topical 0.5% moxifloxacin plus topical steroids plus corneal cross-linking.
- Primary Outcome Measures
Name Time Method Best Spectacle-Corrected Visual Acuity 6 Months Best Spectacle-Corrected Visual Acuity
- Secondary Outcome Measures
Name Time Method Best Spectacle-Corrected Visual Acuity 3 Weeks, 3 Months, 12 Months Best Spectacle-Corrected Visual Acuity
Number of Ulcers Testing Positive for Bacteria on Repeat Culture 2 Days Microbiological cure on repeat culture: A scraping of the corneal ulcer taken at 48 hours, then swabbed onto a culture plate and assessed for bacteria
Scar Size 3 Weeks, 3 Months, 6 Months 12 Months Geometric Mean
Scar Depth 3 Weeks, 3 Months, 6 Months, 12 Months Geometric Mean
Adverse Events 12 Months Adverse Events
Trial Locations
- Locations (3)
Aravind Eye Care System
🇮🇳Madurai, Tamil Nadu, India
Francis I. Proctor Foundaiton
🇺🇸San Francisco, California, United States
University of Miami
🇺🇸Miami, Florida, United States