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

• Status: Withdrawn
• Trial end date: 2019-07-03
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cornea Research Foundation of America
• Treatments: Amphotericin B; Liposomal amphotericin B

Criteria

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