PACK-CXL multicenter trial: preliminary results

Session Details

Session Title: Presented Poster Session: Cross-Linking

Venue: Poster Village: Pod 2

First Author: : E.Torres-Netto SWITZERLAND

Co Author(s): :    R. Shetty   H. Nagaraja   B. Knyazer   S. Chen   S. Kling   F. Hafezi        

Abstract Details

Purpose:

Severe visual impairment due to corneal infection is a major cause of global blindness. The socioeconomic costs related to corneal ulcers and their treatment are immense. PACK-CXL (photoactivated chromophore for infectious keratitis-corneal cross-linking), in contrast, does not require expensive medication, but rather Vitamin B2 solution and a light source. In addition, previous data show that PACK-CXL is also efficient in antibiotic-resistant infections. Our objective was to analyze the time to corneal epithelization with PACK-CXL as a first-line treatment in early infectious corneal ulcers, and compare it to the current standard of care, antimicrobial therapy.

Setting:

This preliminary phase of the study was conducted jointly by the Center for Applied Biotechnology and Molecular Medicine at the University of Zurich (Zurich, Switzerland), the Narayana Nethralaya Eye Hospital (Bangalore, India), the Ben-Gurion University of the Negev Sheva (Beer-Sheva, Israel) and the Wenzhou Medical University (Wenzhou, China).

Methods:

This is a prospective, interventional, multicenter, randomized controlled phase-III clinical trial. The inclusion criteria were infiltrates and early ulcers up to 2mm in diameter and 300μm depth. If patient was on antibiotic/antifungal therapy, it was interrupted at least one day prior to PACK-CXL treatment. Patients were randomized into two groups: PACK-CXL only or Medication only. In the PACK-CXL group, epithelial removal around the borders was followed by application of a riboflavin and irradiation with UV-A (total energy 5.4J/cm2). The medication group received the current standard of care, antimicrobial therapy. Time of corneal re-epithelialization was compared in both groups.

Results:

Nineteen patients were included in this phase, seven in the PACK-CXL group and twelve in the medication group. One patient in the medication group developed corneal perforation on the eleventh day after initiation of antibiotic therapy and was removed from this analysis. Gram-positive cocci were the most commonly identified pathogens. One case of filamentous fungal keratitis (Aspergillus sp) was identified in one eye treated with PACK-CXL. No significant differences in corneal re-epithelization time were observed between the groups (respectively, 10.0 7.3 vs 7.0 6.0 days, p = 0.354).

Conclusions:

Our results suggest that PACK-CXL may be an alternative primary treatment for infectious corneal infiltrates and early corneal ulcers. Even with a tendency for a longer healing (non-significant difference of 3 days), all eyes treated with PACK-CXL healed without the use of antimicrobial therapy. While the preliminary results of this multicenter randomized trial are promising, a larger sample is needed to further investigate the efficacy and safety of this treatment modality.

Financial Disclosure:

has significant investment interest in a company producing, developing or supplying product or procedure presented, receives non-monetary benefits from a company producing, developing or supplying the product or procedure presented.