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临床试验/NCT04727411
NCT04727411已完成不适用

In Vivo Imaging and Impression Cytology Analysis of Conjunctival Changes as Potential Indicators for Ab-interno Gelatin Microstent Implantation Surgery Outcomes

Hospital Clinic of Barcelona2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
2
主要终点
In vivo confocal microscopy of the filtering bleb

研究概览

简要总结

Trabeculectomy and XEN45 gel stent implantation are glaucoma surgeries that creates an aqueous humor (AH) shunt towards the subconjunctival space (filtration bleb). Once the AH reaches the subconjunctival space, it is removed by different paths such as the trans-bleb wall route. For this reason, the conjunctiva is considered an essential structure that may condition the glaucoma filtering procedures outcomes. As part of the inflammatory response, an unbalanced fibrosis during the postoperative period may lead to a bleb cavity scarring and failure; for this reason, bleb massage and antifibrotic injections (i.e., 5-Fluoruracil) are frequently required as part of the postoperative care of these procedures. There have been described several risk factors, such as intraocular pressure (IOP) lowering medications, previous surgical interventions or ocular surface disease that may predispose to an early failure. These preoperative factors fail to aim to predict the surgical outcomes.

However, ocular biomarkers may overcome this limitation. There are promising studies that have analyzed the role of in vivo confocal microscopy (IVCM), anterior-segment optical coherence tomography (AS-OCT) and conjunctival cytology impression as clinical tools that may improve the filtration bleb assessment at a cellular level.

详细描述

Detailed description Hypothesis

  • Conjunctival biomarkers may represent a predictive factor to determine the XEN45 and trabeculectomy surgical success and outcomes
  • A cellular-based analysis may help to predict postoperative pro-fibrotic changes that may lead to an early or mid-term surgery failure, and therefore it could help to improve the postoperative care of the filtering bleb.

Objective

  • To evaluate the preoperative and postoperative conjunctival factors that may influence in the surgical outcomes of XEN45 gel stent compared to trabeculectomy using in vivo confocal microscopy, anterior segment optical coherence tomography and conjunctival cytology impression
  • To assess the efficacy of XEN Gel stent and trabeculectomy to predict IOP, based on the morphologic characteristics of the filtering bleb
  • To analyze the needling rate during the postoperative bleb management and the potential correlation to the pre and postoperative conjunctival changes and surgical success outcomes

Design Single-center, prospective, simple-blind study

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Primary open angle glaucoma
  • Written informed consent
  • Older than 18 years old

排除标准

  • Patients that don't fully understand the purpose and the postoperative care
  • Severe or end-stage glaucoma
  • Patients with prior ocular surgery, excluding uncomplicated phacoemulsification 6 months prior to the inclusion in the study

结局指标

主要结局

In vivo confocal microscopy of the filtering bleb

时间窗: Preoperative to 6 months operative

Increase of the mean microcysts density (MMD): number of cysts/mm2

Conjunctival impression cytology of the filtering bleb

时间窗: Preoperative to 6 months operative

Increase in the percentage of goblet cells biomarkers

Anterior segment optical coherence tomography microscopy of the filtering bleb

时间窗: Preoperative to 6 months operative

Differences in thickness of the conjunctival epithelial surface and the bleb wall, in micrometers

次要结局

  • Intraocular pressure(Preoperative to 6 months visit, at each follow-up visit)
  • Glaucoma medications(Preoperative to 6 months visit, at each follow-up visit)

研究者

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

Néstor Ventura

Investigator, Glaucoma Department

Hospital Clinic of Barcelona

研究点 (2)

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