At a glance
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Swiss PACK-CXL (Photoactivated Chromophore for Infectious Keratitis Cross-linking) Multicenter Trial for the Treatment of Infectious Keratitis
In Brief
A Phase 3 clinical trial evaluating PACK-CXL, Cefazolin in combination with either tobramycin or gentamicin, and 3 other interventions for Keratitis; Infectious Disease (Manifestation). Completed, enrolled 35 participants across 1 site.
Detailed Summary
To assess the safety and efficacy of PACK-CXL (photoactivated chromophore for infectious keratitis cross-linking) as a firstline treatment for infectious corneal infiltrates and early corneal ulcers, and compare it to the current standard of care, antimicrobial therapy.
Study Details
Timeline
Interventions
Local anesthesia \- Oxybuprocaine or Tetracaine, 1 drop each, applied together, every 3 minutes, total of 3 times Abrasio - Abrasio: 1 mm around the borders of the infiltrate/ulcer Corneal scrape Hypo-osmolaric riboflavin solution \- Apply one drop every 2 minutes for 20 minutes UV-A irradiation * 3 mW/cm2 for 30 minutes or 9 mW/cm2 for 10 minutes, 18 mW/cm2 for 5 minutes, 30 mW/cm2 for 3 minutes all allowed (see paper Richoz et al) * Treatment diameter: use a irradiation diameter of 6 to 8 mm, keep the infiltrate/ulcus centered. Additional postoperative treatment * Homatropin or Scopolamin, if anterior chamber reaction * Systemic NSAID/NSAR, if substantial pain * Do not use: topical or systemic steroids, topical NSAID/NSAR, paracetamol, vitamin A ointment, patching
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).
Cycloplegic agents (cyclopentolate 1% eye drops): to decrease pain and synechia risk is at the physician discretion.
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)
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