跳至主要内容
临床试验/NCT07461129
NCT07461129进行中(未招募)不适用

Electrophysiological Changes in Cases of Different Stages of Keratoconus

Minia University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年8月20日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
50
试验地点
1
主要终点
Measuring the amplitude of P100 wave in pattern visual evoked potential

研究概览

简要总结

Keratoconus is a bilateral and asymmetric disease which results in progressive thinning and steeping of the cornea leading to irregular astigmatism and decreased visual acuity.A typical patient with keratoconus presents in the teens or early twenties with complaints of blurring or distortion in vision and having to change glasses frequently due to changes in refractive error.

Corneal thinning frequently precedes ectasia. In moderate and advance cases, a hemosiderin arc or circle line, known as Fleischer's ring, is frequently seen around the cone base. Vogt's striaes, which are fine vertical lines produced by Descemet's membrane compression, is another characteristic sign. Most patients eventually develop corneal scarring. Munson's sign, a V-shape deformation of the lower eyelid in downward position; Rizzuti's sign, a bright reflection from the nasal area of the limbus when light is directed to the limbus temporal area; and breakages in Descemet's membrane causing acute stromal oedema, known as hydrops, are observed in advanced stages.

Corneal blindness is one of the major causes of reversible blindness, which can be managed with transplantation of a healthy donor cornea. It is the most successful organ transplantation in the human body as cornea is devoid of vasculature, minimizing the risk of graft rejection.

Preoperative clinical evaluation of visual potential after corneal transplantation in the patient with dense corneal opacity remains difficult using only history and biomicroscopic examination. Some studies found that electrophysiologic tests were good predictors of visual prognosis prior to corneal transplantation.

Electrophysiology is an objective functional test of the visual pathway and allows the location of visual dysfunctions to be detected. Full-field electroretinography (ERG) is an established clinical technique used to evoke and record mass responses of the retina to flashes of light. The ISCEV Standard full-field ERGs assess generalized retinal function under dark-adapted (DA) and light-adapted (LA) conditions.The visual evoked potential (VEP) is a cortical response and serves as a functional test of the entire visual pathway from the eye to the visual system of the brain.

详细描述

Aim of the Study To assess the effect of different stages of keratoconus on electrophysiology test results.

All patients will undergo a comprehensive ocular examination including:

  1. Best corrected visual acuity (BCVA).
  2. Anterior segment examination using slit lamp bio microscopy.
  3. Posterior segment examination using a +78 D condensing lens and peripheral retinal examination by means of binocular indirect ophthalmoscopy (keeler ophthalmoscope).
  4. Penatacam examination to define grade of KC and corneal topography.
  5. OCT-ONH to assess the function of optic nerve. 6-Electrophysiological tests:

All subjects will be examined using:

  1. FVEP: via the assessment of the amplitude &latency of P2 wave
  2. PVEP:via the assessment of the amplitude &latency of P100 wave 3- Full field flash ERG: via the assessment of the amplitude & implicit time of a&b waves

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • Patients aged from 18 to 40 years with keratoconus of different stages

排除标准

  • Keratoconus Patients with any prior history of ocular procedures.
  • Patients with dense cataract.
  • Patients with retinal , vitreous problems or uveiitis .
  • Patients with optic nerve pathology
  • History of ocular medications e.g antiglaucoma
  • History of previous ocular surgery

研究组 & 干预措施

Keratoconus group

Patients with different stages of keratoconus

Normal

patients whose pentacam doesn't show any keratoconus findings or any other abnormalities

结局指标

主要结局

Measuring the amplitude of P100 wave in pattern visual evoked potential

时间窗: 6 months

Measuring the amplitude of P100 wave of pattern visual evoked potential in mico-voltage in different stages of keratoconus using the (Roland Consult Supercolor Ganzfeld Q450 SC)

Measuring the Latency of P100 wave of pattern evoked potential

时间窗: 6 months

Measuring the latency of P100 wave of pattern visual evoked potential in mico-second in different stages of keratoconus using the (Roland Consult Supercolor Ganzfeld Q450 SC)

Measuring the Amplitude of P2 of Flash visual evoked potential

时间窗: 6 months

Measuring the amplitude of P2 wave of Flash visual evoked potential in mico-voltage in different stages of keratoconus using the (Roland Consult Supercolor Ganzfeld Q450 SC)

measuring the latency of P2 wave of Flash visual evoked potential

时间窗: 6 months

Measuring the latency of P2 wave of Flash visual evoked potential in mico-second in different stages of keratoconus using the (Roland Consult Supercolor Ganzfeld Q450 SC)

Measuring the Amplitude of a wave of Full Field Flash Electroretinography

时间窗: 6 months

Measuring the amplitude of a wave of full field flash ERG in mico-voltage in different stages of keratoconus using the (Roland Consult Supercolor Ganzfeld Q450 SC)

measuring the implicit time of a wave of Full Field Flash Electroretinography

时间窗: 6 months

Measuring the Implicit time of a wave of full field flash ERG in mico-second in different stages of keratoconus using the (Roland Consult Supercolor Ganzfeld Q450 SC)

Measuring the amplitude of b wave of Full Field Flash Electroretinography

时间窗: 6 months

Measuring the amplitude of b wave of full field flash ERG in mico-voltage in different stages of keratoconus using the (Roland Consult Supercolor Ganzfeld Q450 SC)

Measuring the implicit time of b wave of Full Field Flash Electroretinography

时间窗: 6 months

Measuring the implicit time of b wave of full field flash ERG in mico-second in different stages of keratoconus using the (Roland Consult Supercolor Ganzfeld Q450 SC)

次要结局

未报告次要终点

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa Mohamed Riad Qassem

MD

Minia University

研究点 (1)

Loading locations...

相似试验

Electrophysiological Changes in Cases of Different... | 临床试验