Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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
Phase
Phase 3
Funding Agency/Sponsor
Other
Disease
Cornea
Enrollment Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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