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临床试验/NCT07506551
NCT07506551进行中(未招募)不适用

Vitreous Proteomics of Patients Suffering From Pseudoexfoliation Syndrome and Epiretinal Membrane or Macular Hole: a Pilot Study

Prim. Prof. Dr. Oliver Findl, MBA1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年7月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
24
试验地点
1
主要终点
Protein levels

研究概览

简要总结

Determination of proteins and their levels in the vitreous of eyes with or without pseudoexfoliation syndrome (PEX)

详细描述

Pseudoexfoliation syndrome (PEX) is a systemic disorder that leads to the deposition of extracellular material in various tissues, particularly in the anterior segment of the eye. This material consists mainly of elastic microfibrils. PEX is believed to be an age-related condition whose incidence and prevalence vary by region but increase in patients over 50 years of age. Due to demographic changes, the number of PEX patients is expected to rise, making it important to understand this condition, its pathogenesis, and its complications.

The pathogenesis of PEX syndrome has not yet been fully elucidated. The interplay of growth factors, oxidative stress, inflammation, and cellular damage is described as a key factor in the development of the disease. Detailed immunohistochemical and biochemical studies have shown that several proteins are heavily involved in the pathogenesis of PEX.

The anterior segment of the eye is frequently affected by PEX, where the PEX material is present in the aqueous humor, and its accumulation leads to visible deposits on the anterior lens capsule, the edge of the pupil, or the anterior chamber angle. Several proteomics studies of the aqueous humor have been conducted, demonstrating that oxidative stress and inflammation contribute to the development of PEX. However, there is a lack of studies on PEX and its effects on the posterior segment. Some studies suggest that the posterior segment is primarily affected. Interestingly, PEX has recently been linked to diseases/pathologies of the vitreoretinal interface (VRI). It has been shown that the rates of posterior vitreous detachment (PVD) and epiretinal membranes (ERM) are higher in eyes with PEX.

The pathogenesis of ERM is not fully understood, but similar to PEX, inflammation, inflammatory proteins, and cytokines appear to play an important role in the development of ERM.

To further investigate the differences in proteins and their levels in the vitreous humor of PEX and non-PEX eyes, the aim of the study is to perform a non-targeted proteomic analysis using liquid chromatography coupled with mass spectrometry (LC-MS) of the vitreous humor from PEX eyes with ERM, compared to vitreous humor without PEX but with ERM.

研究设计

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

入排标准

年龄范围
21 Years 至 105 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • PEX syndrome
  • Macular pucker or macular hole and scheduled for vitrectomy
  • Age 21 or older
  • Written informed consent prior to surgery

排除标准

  • Previous vitrectomy or intravitreal application of drugs
  • Systemic anti-inflammatory drugs
  • Pre- surgical topical anti-inflammatory drugs (NSAR, Steroids)
  • Pre- surgical topical prostaglandins
  • Diabetic retinopathy
  • PEX Syndrome only in the contralateral eye (the eye not scheduled for surgery)

研究组 & 干预措施

Patients scheduled for vitrectomy

Other

Patients with epiretinal membranes or macular holes with or without pseudoexfoliation syndrome

干预措施: Liquid chromatography mass spectrometry (Other)

结局指标

主要结局

Protein levels

时间窗: 24 months

Protein levels in vitreous samples of patients with and without pseudoexfoliation syndrome will be measured using Liquid chromatography mass spectrometry

次要结局

未报告次要终点

研究者

发起方
Prim. Prof. Dr. Oliver Findl, MBA
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prim. Prof. Dr. Oliver Findl, MBA

Principal Investigator

Vienna Institute for Research in Ocular Surgery

研究点 (1)

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