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

A Randomized, Double-masked, Placebo-controlled Study of the Safety of Amphotericin 0.255 μg/mL in Optisol-GS

Status

Withdrawn

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04018417

Enrollment

Registered

2019-07-12

Start date

2019-07-03

Completion date

2019-07-03

Last updated

2019-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fuchs' Endothelial Dystrophy

Brief 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.

Interventions

DRUGAmphotericin B

Drug concentration: 0.255 μg/mL

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Endothelial cell density	6 months	Central corneal endothelial cell density will be assessed by specular microscopy

Secondary

Measure	Time frame	Description
Incidence of post-keratoplasty fungal keratitis	6 months	The incidence of post-keratoplasty fungal keratitis will be assessed.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026