A clinical trial to study the outcomes of additional steroid drops and a corneal strengthening procedure in corneal ulcers caused by bacteria
- Conditions
- Health Condition 1: H160- Corneal ulcer
- Registration Number
- CTRI/2019/01/017136
- Lead Sponsor
- Dr Thomas M Lietman
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of Best-spectacle corrected visual acuity 3 months after enrollment in the study <br/ ><br>Timepoint: 3 months
- Secondary Outcome Measures
Name Time Method <br/ ><br>1) To determine if early topical steroids are a beneficial adjuvant in the treatment of smear-positive bacterial ulcers. <br/ ><br>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