Evaluation of Amphotericin B in Optisol-GS for Prevention of Post-Keratoplasty Fungal Infections.
Withdrawn before enrolling · Phase 2/Phase 3
Conditions studied: Fuchs' Endothelial Dystrophy
In brief
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.
Key facts
- Study ID
- NCT04018417
- Run by
- Cornea Research Foundation of America
- People needed
- 0
- Starts
- 2019-07-03
- Expected to finish
- 2019-07-03
- Last updated by the study team
- 2019-07-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female at least 18 years of age and any race or ethnicity
- Scheduled to have Descemet membrane endothelial keratoplasty
You may not qualify if…
- 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
Where it is running
- Price Vision Group — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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