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| ID | Type | Description | Link |
|---|---|---|---|
| UG1EY028518 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Aravind Eye Care System | OTHER |
| National Eye Institute (NEI) | NIH |
| University of Miami | OTHER |
| Stanford University |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Therapy | Placebo Comparator | Participants in this arm will receive topical 0.5% moxifloxacin plus topical placebo plus sham corneal cross-linking. |
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| Early Steroids | Experimental | Participants in this arm will receive topical 0.5% moxifloxacin plus topical steroids plus sham corneal cross-linking. |
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| Cross-Linking plus Early Steroids | Experimental | Participants in this group will receive topical 0.5% moxifloxacin plus topical steroids plus corneal cross-linking. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxifloxacin Ophthalmic | Drug | Topical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is standard therapy for bacterial keratitis. Immediately after CXL/sham CXL and repeat culture, all participants will receive topical moxifloxacin drops every 1 hour for 2 days, and then every 2 hours while awake until resolution of the epithelial defect. |
| Measure | Description | Time Frame |
|---|---|---|
| Best Spectacle-Corrected Visual Acuity | Best Spectacle-Corrected Visual Acuity | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Best Spectacle-Corrected Visual Acuity | Best Spectacle-Corrected Visual Acuity | 3 Weeks, 3 Months, 12 Months |
| Number of Ulcers Testing Positive for Bacteria on Repeat Culture | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tom Lietman, MD | University of California, San Francisco | Principal Investigator |
| Jennifer Rose-Nussbaumer, MD | Stanford University | Principal Investigator |
| Nicole Varnado, MPH | Stanford University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Francis I. Proctor Foundaiton | San Francisco | California | 94143 | United States | ||
| University of Miami |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40705354 | Derived | Prajna NV, Lalitha P, Chandru S, Radhakrishnan N, Christy J, Karthikeyan A, Rajaraman R, Ramesh R, Amescua G, Mandlik K, Abdelrahman S, Varnado N, Kanchugantla M, Arnold B, Lietman TM, Rose-Nussbaumer JR. Steroids and Cross-Linking for Ulcer Treatment: The SCUT II Randomized Clinical Trial. JAMA Ophthalmol. 2025 Jul 24;143(9):723-30. doi: 10.1001/jamaophthalmol.2025.2188. Online ahead of print. | |
| 38112645 | Derived | Keenan JD. Steroids in the Management of Infectious Keratitis. Cornea. 2023 Nov 1;42(11):1333-1339. doi: 10.1097/ICO.0000000000003340. Epub 2023 Jul 4. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 12, 2025 | May 28, 2025 | 14 | ||
| Jul 1, 2025 |
| ID | Term |
|---|---|
| D000094504 | Corneal Cross-Linking |
| ID | Term |
|---|---|
| D010778 | Photochemotherapy |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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| OTHER |
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| Difluprednate Ophthalmic | Drug | Difluprednate 0.05% is a corticosteroid used to reduce inflammation in the eye. Participants will receive one drop of 0.05% difluprednate four times daily beginning 24 hours after the initiation of antibiotics for 1 week, decreased by 1 drop weekly for a total of 4 weeks of steroid therapy. |
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| Riboflavin Ophthalmic | Drug | All participants will receive a 30 minute loading dose of topical 0.1% riboflavin and 20% dextran T500 drops every 2 minutes. For participants randomized to corneal cross-linking(CXL), this will be followed by exposure to UV-A light at a wavelength of 365 nm with an irradiance of 3 mW/cm2 for 30 minutes for a total dose of 5.4 J/cm2 (UV lamp: PESCHKE Meditrade GmbH, Hueneberg, Switzerland for India; Avedro KXL System, Waltham, MA, USA for USA). During irradiation patients will continue to receive topical riboflavin at 5-minute intervals. For those randomized to sham CXL, this experience is simulated however the light will be shined adjacent to the patient, careful to avoid exposure to the cornea. |
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| Topical Placebo | Other | Participants randomized to topical placebo will receive topical placebo on the same medication schedule as difluprednate: one drop of 0.05% difluprednate four times daily beginning 24 hours after the initiation of antibiotics for 1 week, decreased by 1 drop weekly for a total of 4 weeks of placebo therapy. Placebo will be the vehicle used in difluprednate. |
|
| 2 Days |
| Scar Size | Geometric Mean | 3 Weeks, 3 Months, 6 Months 12 Months |
| Scar Depth | Geometric Mean | 3 Weeks, 3 Months, 6 Months, 12 Months |
| Adverse Events | Adverse Events | 12 Months |
| Miami |
| Florida |
| 33136 |
| United States |
| Aravind Eye Care System | Madurai | Tamil Nadu | India |
| 34901464 | Derived | Radhakrishnan N, Prajna VN, Prajna LS, Venugopal A, Narayana S, Rajaraman R, Amescua G, Porco TC, Lietman TM, Rose-Nussbaumer J. Double-masked, sham and placebo-controlled trial of corneal cross-linking and topical difluprednate in the treatment of bacterial keratitis: Steroids and Cross-linking for Ulcer Treatment Trial (SCUT II) study protocol. BMJ Open Ophthalmol. 2021 Nov 29;6(1):e000811. doi: 10.1136/bmjophth-2021-000811. eCollection 2021. |
| Jul 17, 2025 |
| 15 |
| Jan 15, 2026 | Jan 30, 2026 | 16 |
| D010789 |
| Phototherapy |