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临床试验/NCT05138315
NCT05138315Unknown不适用

Quantification of Metamorphopsia Using the Alleye App Compared to the M-chart in Patients With Epiretinal Membranes a Pilot Study

Vienna Institute for Research in Ocular Surgery2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年11月16日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
M-chart Scores (horizontal and vertical)

研究概览

简要总结

Aim of this study is to examine metamorphopsia before and 3 months after vitrectomy with membrane peeling among patients with idiopathic epiretinal membranes. Therefore, the correlation between the Alleye App and the M-chart test before and after ERM surgery and the associations of OCT biomarkers to postsurgical changes in metamorphopsia scores will be examined.

详细描述

Epiretinal membranes are common disorders leading to visual loss and metamorphopsia in later stages. In most cases they are idiopathic with no identifiable cause (iERM). ERM can be visualized with optical coherence tomography (OCT) and can cause metamorphopsia, usually diagnosed with the Amsler grid or metamorphopsia chart (M-chart), which have influence on vision. ERM are surgically treated by vitrectomy and membrane peeling, however, postoperative visual acuity and quality of vision are difficult to predict. Quality of vision is highly dependent on metamorphopsia which can be an overlooked symptom. Thus, detailed examinations using M-charts prior to surgery can help to quantify the degree of metamorphopsia and might predict the potential benefit of the surgery. Recently, home monitoring tests for metamorphopsia using handheld mobile devices are becoming increasingly important. The Alleye App is one of two m-health applications with FDA approval, that is already in use for monitoring the progression of metamorphopsia in other retinal diseases such as age-related macular degeneration (AMD). It has yet to be evaluated for ERM. Aim of this study is to examine the correlation between the Alleye App and the M-chart test before and after ERM surgery and the associations of OCT biomarkers to postsurgical changes in metamorphopsia scores.

研究设计

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

入排标准

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

入选标准

  • Idiopathic ERM
  • Sheduled surgery (vitrectomy with membrane peeling)
  • Age 18 and older
  • Written informed consent for participation in the study
  • Metamorphopsia detected by the Amsler grid
  • BCVA ≥ 0,1

排除标准

  • Secondary ERM due to retinal tears, retinal detachment, retinal vascular diseases and uveitis
  • Other macular disorders including AMD
  • Previous intraocular surgery except for uncomplicated cataract surgery
  • Pregnancy (pregnancy test will be performed in women of reproductive age)

结局指标

主要结局

M-chart Scores (horizontal and vertical)

时间窗: 5 minutes

The M-charts measure the degree of horizontal and vertical metamorphopsia, the range of M-charts: 0 to 2.0, with higher values indicating a higher degree of metamorphopsia

Alleye App Score

时间窗: 5 minutes

The Alleye App measures the degree of metamorphopsia, the range of the Alleye App Score: 0 to 100 points, with 100 being the best achievable result, while lower values are associated with increasing degree of metamorphopsia

次要结局

未报告次要终点

研究者

发起方
Vienna Institute for Research in Ocular Surgery
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prim. Prof. Dr. Oliver Findl, MBA

Prof., MD, MBA

Vienna Institute for Research in Ocular Surgery

研究点 (2)

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