Swiss PACK-CXL Multicenter Trial for the Treatment of Infectious Keratitis

PHASE3CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

October 31, 2020

Study Completion Date

October 31, 2020

Conditions
Keratitis; Infectious Disease (Manifestation)
Interventions
DEVICE

PACK-CXL

"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"

DRUG

Cefazolin in combination with either tobramycin or gentamicin

"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)."

DRUG

Cycloplegic agents (cyclopentolate 1% eye drops)

Cycloplegic agents (cyclopentolate 1% eye drops): to decrease pain and synechia risk is at the physician discretion.

DRUG

Fluoroquinolones (Besifloxacin ; ciprofloxacin ; gatifloxacin ; levofloxacin ; moxifloxacin ; ofloxacin )

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)

DRUG

Corticosteroids (prednisolone acetate 0.5% or 1% eye drops)

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

Trial Locations (1)

1211

University of Geneva, Geneva

All Listed Sponsors
lead

University Hospital, Geneva

OTHER

NCT02717871 - Swiss PACK-CXL Multicenter Trial for the Treatment of Infectious Keratitis | Biotech Hunter | Biotech Hunter