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A clinical trial to study the outcomes of additional steroid drops and a corneal strengthening procedure in corneal ulcers caused by bacteria

Steroids and Cross-linking for Ulcer Treatment (SCUT II)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/017136
Enrollment
270
Registered
2019-01-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H160- Corneal ulcer

Interventions

Intervention1: Intervention 2 - Difluprednate 0.05% with moxifloxacin: Difluprednate 0.05% 4t/d for 1 week followed by tapering doses, decreased by 1 drop weekly for a total of 4 weeks of steroid ther

Sponsors

Dr Thomas M Lietman
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Corneal ulcer that is smear positive for typical bacteria (i.e. non-Nocardia or Mycobacteria) 2. Moderate to severe vision loss, defined as Snellen visual acuity of 20/40 or worse 3. Corneal thickness �300 µm, as measured on Anterior Segment-Optical Coherence Tomography 4. Basic understanding of the study as determined by the physician 5. Commitment to return for follow up visits

Exclusion criteria

Exclusion criteria: 1. Evidence of concomitant infection on exam, gram stain, or confocal microscopy (i.e. herpes, both bacteria and acanthameoba on gram stain) 2. Impending or frank perforation at recruitment 3. Involvement of sclera at presentation 4. Non-infectious or autoimmune keratitis 5. History of corneal transplantation or recent intraocular surgery 6. Pinhole visual acuity worse than 20/200 in the unaffected eye 7. Participants who are decisionally and/or cognitively impaired

Design outcomes

Primary

MeasureTime frame
Assessment of Best-spectacle corrected visual acuity 3 months after enrollment in the study Timepoint: 3 months

Secondary

MeasureTime frame
1) To determine if early topical steroids are a beneficial adjuvant in the treatment of smear-positive bacterial ulcers. 2) To determine which ulcer characteristics predict the most benefit from the addition of adjuvant corneal cross-linking and/or early steroids.Timepoint: 3 months

Countries

United States of America

Contacts

Public ContactDr N Venkatesh Prajna

Aravind Eye Hospital

prajna@aravind.org914524356312

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026