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临床试验/CTRI/2023/06/054433
CTRI/2023/06/054433尚未招募不适用

An interventional study to evaluate surgical outcomes after descemets membrane endothelial keratoplasty(DMEK) and pre-descemets endothelial keratoplasty(PDEK) for corneal endotheliopathies

department of OPhthalmology1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年6月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
visual acuity

研究概览

简要总结

Until the last years of last century, Penetrating Keratoplasty (PK) was theonly way to surgically treat endothelial dysfunction. . Since then there has been a major change in medical management of thesepathologies.

A technique of EK is  Descemet Membrane Endothelial Keratoplasty (DMEK). It involves removal of Descemet’s membrane andendothelium,but with replacement of only these two layers without posteriorstroma. It claims an even faster visual recovery and better visual outcome thanwith DSAEK(Also a technique of EK)       Pre‑Descemet’s EK (PDEK) is a newer variant in the arena of EK , is a novel procedure and itinvolves the separation of PDL along with DM‑endothelium asa donor lenticule after performing descemetorrhexis. Accordingto proponents of the technique PDEK offers the ability to use corneal tissuefrom younger donars.

The most significant advantage of PDEK is that it is notdependent on the corneal donor age, whereas DMEK cannot be done unless thedonor is above 40 years of age, given the increased tendency for graftscrolling. Additionally, a PDEK graft is advantageous in that it is only 25 µmto 30 µm thick, minimizing graft-host interface postoperative haze. Notably,even though the PDEK graft is thin, the pre-Descemet’s layer preservationwithin the graft is the critical component that allows for ease of graftmovement within the eye, minimizing the risk of graft tearing.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •Patients who will give written informed consent.
  • •All patients of PBK, Corneal Decompensation, Endotheliopathies without any active infection.

排除标准

  • Patients with Corneal Scar .
  • Patient with anterior chamber IOL (ACIOL) .
  • Patient with iris Scars and large Atrophic Patches .Patient with Glaucoma Shunt Surgery.

结局指标

主要结局

visual acuity

时间窗: 3 month

endothelial count

时间窗: 3 month

central corneal thickness

时间窗: 3 month

NCT

时间窗: 3 month

次要结局

  • visual acuity(endothelial count)

研究者

申办方类型
Government medical college

研究点 (1)

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