Evaluation of Amphotericin B in Optisol-GS for Prevention of Post-Keratoplasty Fungal Infections.

Cornea Research Foundation of America

Status and phase

Withdrawn

Phase 3

Phase 2

Conditions

Fuchs' Endothelial Dystrophy

Treatments

Drug: Amphotericin B

Study type

Interventional

Funder types

Other

Identifiers

NCT04018417

2019-005

Details and patient eligibility

About

With the increasing popularity of endothelial keratoplasty, a coincident increase in the rate of fungal infections post-keratoplasty has been seen in the United States. In this study, the eye bank will harvest pairs of donor corneas and randomize one cornea from each pair to be stored in Optisol-GS per Eye Bank Association of America guidelines. The eye bank will add amphotericin B 0.255 μg/mL (antifungal) to the storage solution for the mate cornea. The study donor corneas will be assigned to participants who are scheduled to undergo Descemet membrane endothelial keratoplasty. The surgeons, participants, and evaluators will remain masked regarding the donor cornea storage solution assignment. The participants will be followed for 6 months.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female at least 18 years of age and any race or ethnicity
Scheduled to have Descemet membrane endothelial keratoplasty

Exclusion criteria

History of glaucoma surgery in operative eye
Known allergy or intolerance to amphotericin B
Presence of anterior chamber intraocular lens
Corneal stromal or epithelial dysfunction
Presence of glaucoma defined as optic nerve damage as confirmed on Humphrey visual field testing or retinal nerve fiber layer analysis
Presence of peripheral anterior synechiae