Cross-linking for Corneal Ulcers Treatment Trial
Completed · Phase 3
Conditions studied: Corneal Ulcer, Infectious Keratitis, Bacterial Ulcer, Fungal Ulcer
In brief
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.
Key facts
- Study ID
- NCT02570321
- Run by
- University of California, San Francisco
- People needed
- 147
- Starts
- 2015-11-01
- Expected to finish
- 2019-03-19
- Last updated by the study team
- 2025-06-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Proctor Foundation, UCSF — San Francisco, California, United States
- Aravind Eye Hospitals — Madurai, Tamil Nadu, India
Full record on ClinicalTrials.gov
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