A Prospective Study of Outcomes with Corneal Tissue Preserved in Amphotericin B Supplemented Corneal Storage Media

Background:

Fungal infections (endophthalmitis and keratitis) are rare after penetrating keratoplasty. However, with the increasing popularity of endothelial keratoplasty, a coincidental increase in the rate of fungal infections post-keratoplasty has been seen in the United States and abroad. It has been hypothesized that the lamellar interface is a potential space for fungal elements to congregate and proliferate, while being protected from eye drops, combined with additional warming that occurs during tissue preparation for endothelial keratoplasty, may be some of the driving factors. The purpose of this study is the evaluate the outcomes after supplementing the corneal storage media with Amphotericin B at (0.255 μg/mL) to prevent post-keratoplasty fungal infections.

Significance:

Fungal infections after corneal transplantation are uncommon, reported in only 0.035% of US transplants between 2012 and 2014.  When fungal infection occurs, however, it is often visually devastating. At present, the most commonly used corneal storage medium in the United States is Optisol-GS, which contains antibiotics, but no antifungal agents. The most commonly used corneal storage medium in Europe, which has a 30-year track record of safety and efficacy, contains antibiotics as well as the antifungal Amphotericin B. 

Objectives and Purpose:

The primary objective is to evaluate the transplant outcomes post addition of Amphotericin B (0.255 μg/mL) to the corneal storage media. The only way to reliably confirm efficacy in cold storage media is in a human patient clinical trial, much like the clinical trials on intracameral antibiotic efficacy for post cataract surgery endophthalmitis. We will examine all post-operative fungal keratitis, endophthalmitis and primary graft failures.  These will be measured 3 to 6 months post-operatively for all keratoplasties.

Next Steps:

To take part in this important IRB-based study you may simply request inclusion by adding your name to the study register.  Surgeons will have a choice between media with or without Amphotericin B and infection rates will be compared. This study will include all corneal tissue utilized for keratoplasty.  In 3-4 weeks, the study coordinator will contact you to provide the appropriate training and documentation requirements to allow your patient to become a part of this study.