A Randomized, Double-masked, Placebo-controlled Study of the Safety of Amphotericin 0.255 μg/mL in Optisol-GS
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Endothelial cell density
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female at least 18 years of age and any race or ethnicity
- •Scheduled to have Descemet membrane endothelial keratoplasty
排除标准
- •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
研究组 & 干预措施
Amphotericin B
The eye bank will add amphotericin B 0.255 μg/mL to the Optisol-GS donor cornea storage solution.
干预措施: Amphotericin B (Drug)
结局指标
主要结局
Endothelial cell density
时间窗: 6 months
Central corneal endothelial cell density will be assessed by specular microscopy
次要结局
- Incidence of post-keratoplasty fungal keratitis(6 months)