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评估新型 Descemet 膜内皮角膜移植供体准备设备 DescePrep 在非糖尿病和糖尿病供体角膜中的疗效、效率和细胞活力。

Evaluation of Efficacy, Efficiency, and Cell Viability of a Novel Descemet Membrane Endothelial Keratoplasty Graft Preparation Device, DescePrep, in Nondiabetic and Diabetic Human Donor Corneas.

机构信息

Eyedea Medical, Inc., Baltimore, MD.

Center for Bioengineering Innovation & Design, Johns Hopkins University, Baltimore, MD.

出版信息

Cornea. 2022 Apr 1;41(4):505-511. doi: 10.1097/ICO.0000000000002861.

Abstract

PURPOSE

The purpose of this study was to evaluate the safety, efficacy, and efficiency of a Descemet membrane endothelial keratoplasty (DMEK) graft preparation device, DescePrep, through measurement of graft viability, yield, and preparation time in both healthy and diabetic (high-risk) donor eyes.

METHODS

Twenty nondiabetic and 10 diabetic donor corneas were processed using DescePrep, which standardizes the liquid bubble technique. Corneas were stained with trypan blue and then processed. Cell counts through specular microscopy, optical coherence tomography imaging, and slit-lamp analysis were used for the evaluation of graft separation and viability in 5 nondiabetic corneas. The remaining 25 corneas (15 nondiabetic and 10 diabetic) were evaluated for preparation success rate and processing time. Ten corneas (5 nondiabetic and 5 diabetic) were randomly selected for further evaluation of global cell loss through staining.

RESULTS

Ninety-seven percent of corneas (29 of 30) were prepared successfully with DescePrep. The average preparation time was 2.83 ± 1.8 minutes. There was no significant difference in the time of preparation between the nondiabetic and diabetic groups (P = 0.077). The overall average cell death after processing was 7.9% ± 3.7% for all corneas. There was no significant difference in cell viability between diabetic and nondiabetic tissues after DescePrep processing (P = 0.769).

CONCLUSIONS

DescePrep is a new DMEK preparation technique that can process both nondiabetic and diabetic donor corneas at high yields in minutes. High-yield preparation of diabetic corneas may offer eye banks access to a larger donor pool, which is important because the demand for DMEK grafts continues to rise worldwide.

摘要

目的

本研究旨在评估 Descemet 膜内皮角膜移植(DMEK)移植物制备设备 DescePrep 的安全性、有效性和效率,通过测量健康和糖尿病(高危)供体眼中移植物的活力、产量和制备时间来实现。

方法

使用 DescePrep 处理 20 只非糖尿病和 10 只糖尿病供体角膜,该设备标准化了液体气泡技术。用台盼蓝染色后处理角膜。通过共焦显微镜、光学相干断层扫描成像和裂隙灯分析进行细胞计数,用于评估 5 只非糖尿病角膜的移植物分离和活力。其余 25 只角膜(15 只非糖尿病和 10 只糖尿病)用于评估制备成功率和处理时间。随机选择 10 只角膜(5 只非糖尿病和 5 只糖尿病)通过染色进一步评估整体细胞丢失。

结果

97%(30 只中的 29 只)的角膜用 DescePrep 成功制备。平均制备时间为 2.83±1.8 分钟。非糖尿病组和糖尿病组之间的制备时间无显著差异(P=0.077)。所有角膜处理后的平均细胞死亡率为 7.9%±3.7%。DescePrep 处理后,糖尿病和非糖尿病组织的细胞活力无显著差异(P=0.769)。

结论

DescePrep 是一种新的 DMEK 制备技术,可在数分钟内以高产量处理非糖尿病和糖尿病供体角膜。高产量制备糖尿病角膜可能使眼库能够获得更大的供体群体,这很重要,因为全球对 DMEK 移植物的需求持续上升。

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