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

Phase 2

Withdrawn

• Conditions: Fuchs' Endothelial Dystrophy
• Interventions: Drug: Amphotericin B

• Registration Number: NCT04018417
• Lead Sponsor: Cornea Research Foundation of America

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-07
• Study Start: 2019-07-03
• Primary Completion: 2019-07-03
• Study Completion: 2019-07-03
• Study First Submitted: 2019-07-11
• Study First Submitted QC: 2019-07-11
• Last Update Submitted: 2019-07-11
• Study First Posted: 2019-07-12
• Last Update Posted: 2019-07-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amphotericin B	Amphotericin B	The eye bank will add amphotericin B 0.255 μg/mL to the Optisol-GS donor cornea storage solution.

Primary Outcome Measures

Name	Time	Method
Endothelial cell density	6 months	Central corneal endothelial cell density will be assessed by specular microscopy

Secondary Outcome Measures

Name	Time	Method
Incidence of post-keratoplasty fungal keratitis	6 months	The incidence of post-keratoplasty fungal keratitis will be assessed.

Trial Locations

Locations (1)

Price Vision Group; 🇺🇸 Indianapolis, Indiana, United States