Status:
COMPLETED
Steroids and Cross-linking for Ulcer Treatment
Lead Sponsor:
Thomas M. Lietman
Collaborating Sponsors:
Aravind Eye Care System
National Eye Institute (NEI)
Conditions:
Keratitis Bacterial
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2024
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT04097730
Start Date
September 24 2020
End Date
September 18 2024
Last Update
February 3 2025
Active Locations (3)
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1
Francis I. Proctor Foundaiton
San Francisco, California, United States, 94143
2
University of Miami
Miami, Florida, United States, 33136
3
Aravind Eye Care System
Madurai, Tamil Nadu, India