Swiss PACK-CXL Multicenter Trial for the Treatment of Infectious Keratitis
Keratitis; Infectious Disease (Manifestation)
About this trial
This is an interventional treatment trial for Keratitis; Infectious Disease (Manifestation) focused on measuring Collagen cross-linking, PACK-CXL, infectious keratitis, CXL.
Eligibility Criteria
Inclusion Criteria:
- Patient exhibit clinical signs of corneal infiltrate or beginning corneal ulcer on at least one eye, of suspected bacterial, fungal or mixed (bacterial and fungal) origin.
- Infiltrates and early ulcers up to a maximum 2mm in diameter; may lie close to the corneal limbus, but at a minimal distance of 2mm from central cornea.
- Infiltrates and early ulcer depth of a maximum of 300 μm, assessed by either OCT or Scheimpflug imaging
- All lesions must show an open epithelium with fluorescein positive staining
- No previous antibiotic/antifungal treatment OR at least no antibiotic/antifungal treatment for a minimum of 48 hours from last treatment
- Provide signed and dated patient consent form
- Patient willing to comply with all study procedures and be available for the duration of the study
- Male or female, >18 years of age. No children or adolescents of 18 years and less of age will be included in this study.
Exclusion Criteria:
- Lesion/infiltrate involving the central 2mm diameter of the cornea
- Suspicion of non-infectious keratitis, viral or acanthamoeba keratitis or sterile infiltrate.
- Closed epithelium over the lesion
- Pachymetry of less than 400 microns at the thinnest point.
- Patients who cannot participate in the treatment or be monitored with frequent clinician controls as required in the study protocol.
- Corneal perforation
- Descemetocele
- Pregnancy or breastfeeding
- Active corneal herpetic disease
- Systemic treatment involving steroids
- Immunosuppressed/immune-compromised patients
- Patients with diagnosed eczema (or atopic dermatitis)
- Previous keratoplasty
- Patients with monocular vision
Sites / Locations
- University of Geneva
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Treatment (PACK-CXL)
Antimicrobial therapy
Photoactivated chromophore for infectious keratitis-corneal cross-linking (PACK-CXL)
Control arm consists of standard topical antimicrobial therapy recommended for the treatment of microbial keratitis by the American Academy of Ophthalmology. Initial empiric topical antibiotic therapy (eye drops or ocular ointment): 1a. Cefazolin (50mg/ml) in combination with either tobramycin (9-14mg/ml) or gentamicin (9-14mg/ml). OR 1b. a Fluoroquinolones (Besifloxacin 6 mg/ml; ciprofloxacin 3 mg/ml; gatifloxacin 3 mg/ml; levofloxacin 15 mg/ml; moxifloxacin 5 mg/ml; ofloxacin 3 mg/ml) 2. Cycloplegic agents (cyclopentolate 1% eye drops): to decrease pain and synechia risk is at the physician discretion. 3. Corticosteroids (prednisolone acetate 0.5% or 1% eye drops): use of corticosteroids for patients included in the study only after complete closure of the epithelium