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临床试验/NCT04752020
NCT04752020已完成早期 1 期

Prospective Assessment of Whether Adjuvant Netarsurdil Use Improves Post-Operative Outcomes in Patients Undergoing Descemetorhexis Without Endothelial Keratoplasty

Massachusetts Eye and Ear Infirmary1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年3月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
25
试验地点
1
主要终点
Change in endothelial cell count over time

研究概览

简要总结

This will be a prospective assessment of whether adjuvant Netarsudil use in patients undergoing Descemetorhexis without endothelial keratoplasty improves time to corneal clearance and post-operative central endothelial cell counts. The anticipated enrollment is 25 patients.

详细描述

Subjects meeting inclusion criteria will be identified by Massachusetts Eye and Ear cornea surgeons during their pre-operative assessment and invited to participate in the study. Written informed consent will be obtained from the patient. The patients will then be added to a shared Epic patient list with a shared to-do column (outside of the patient record) indicating their subject ID and date of recruitment. All subjects will be asked to provide their best contact phone number which will be updated in the chart.

Upon obtaining informed consent, subjects will receive a bottle of Netarsudil from the Massachusetts Eye and Ear research pharmacy with post-operative instructions to use the drop once a day at bedtime starting on post-operative day 1 . Each patient will then receive regular, scheduled post-operative monitoring with a post-operative day 1 visit, post-operative week 1 visit, post-operative month 1 visit, and then every 2 month follow up for twelve months. Clinical examination, including best corrected visual acuity and intraocular pressure, will be recorded during every visit. Corneal topography and specular microscopy will be performed during the pre-operative assessment and during each bi-monthly visit in order to monitor for post-operative outcomes.

A retrospective chart review will be performed prior to new patient enrollment for patients who had previously had DWEK and did not receive a rho-kinase inhibitor. These patients will be included for pre-operative and post-operative vision, pachymetry, corneal topography results, and specular microscopy results with minimization of data acquisition as no informed consent can be obtained from these patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Fuchs corneal dystrophy

排除标准

  • Women of childbearing potential
  • Other corneal eye diseases
  • Non-compliance with netarsudil
  • Intolerance of netarsudil

研究组 & 干预措施

Netarsudil use

Experimental

Patients will receive Netarsudil eye drops to use 1 drop nightly in the operative eye after DWEK surgery until corneal clearance

干预措施: Netarsudil Ophthalmic (Drug)

结局指标

主要结局

Change in endothelial cell count over time

时间窗: Measured at post-operative month one visit and then every 2 months for 1 year

Central endothelial cell count by specular microscopy

Change in central corneal pachymetry over time

时间窗: Measured at post-operative month one visit and then every 2 months for 1 year

Corneal thickness on clinical examination and corneal topography

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emma C. Davies, MD

Principal investigator

Massachusetts Eye and Ear Infirmary

研究点 (1)

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