Phase 3
N=147
Cross-linking for Corneal Ulcers Treatment Trial
Corneal Ulcer · Infectious Keratitis · Bacterial Ulcer · Fungal Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT02570321 ↗Enrolled (actual)
147
Serious AEs
23.1%
Results posted
Aug 2024
Primary outcome: Primary: Microbiological Cure on Repeat Culture — 5; 5; 17; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Corneal Cross-linking (Procedure); Anti Fungal Drug (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Microbiological Cure on Repeat Culture |
5; 5; 17; 14; 15; 13 | — |
| SECONDARY Best Spectacle-corrected Visual Acuity |
0.82; 1.32; 0.43; 1; 0.48; 0.8 | — |
| SECONDARY Scar Size |
3.5; 3.0; 3.0; 3.9; 3.5; 3.1 | — |
| SECONDARY Adverse Events Including Rate of Perforation/Need for Therapeutic Penetrating Keratoplasty |
1; 0; 2; 1; 4; 3 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02570321). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.