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Cross-linking for Corneal Ulcers Treatment Trial
Recruiting
Trial ID: NCT02570321
Purpose
The primary purpose of this study is to determine if patients randomized to corneal collagen
cross-linking plus medical therapy will have a lower prevalence of positive bacterial or
fungal cultures immediately after the procedure than patients who received medical therapy
alone.
The secondary purpose of this study is to determine if patients randomized to corneal
collagen cross-linking will have a better visual acuity at 3 and 12 months than patients who
receive medical therapy alone.
Official Title
Cross-linking for Corneal Ulcers Treatment Trial
Stanford Investigator(s)
Jennifer Rose-Nussbaumer
Associate Professor of Ophthalmology
Eligibility
Inclusion criteria:
- Corneal ulcer that is smear positive for either bacteria or filamentous fungus
- Pinhole visual acuity worse than 20/70 in the affected eye
- Not treated already with antimicrobial medications at presentation
- 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 or gram stain (i.e. herpes, both bacteria
and acanthamoeba 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
- No light perception in the affected eye
- Pinhole visual acuity worse than 20/200 in the unaffected eye
- Participants who are decisionally and/or cognitively impaired
Intervention(s):
procedure: Bacterial ulcer cross-linking
procedure: Bacterial ulcer control
procedure: Fungal ulcer cross-linking
procedure: Fungal ulcer control
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305