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临床试验/NCT02014389
NCT02014389招募中不适用

Objective Perimetry in Normal Subjects,Glaucoma Patients and Retinal Dystrophy Patients

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2013年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
PLR response amplitude and latency

研究概览

简要总结

Objective perimetry can better monitor visual field defects in retinal dystrophy and Glaucoma patients than conventional subjective perimetry. The PLR ( Pupil Light Reflex to short and long wavelength stimuli should be significantly lower compared to healthy participants in areas of visual field defects in retinal dystrophy and Glaucoma patients.

详细描述

Pupil light reflex (PLR) will be measured by a chromatic multifocal pupillometer in response to short and long wavelength light with small spot stimulus in 76 points of the 30 degree visual field.

A computerized infrared video pupillometer will be used to record changes in pupil diameter in response to short- and long-wavelength stimuli (peak 485 nm and 620 nm, respectively) presented by 76 LEDs, 1.8mm spot size, at light intensities of 10-3000 cd/m2 and duration of 1-3 sec at different points of the 30 degree visual field

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-80 years old.
  • Signing informed consent.
  • Pupillary reflex to light.

排除标准

  • Cloudy corneas.
  • Surgical intraocular ophthalmic procedure within the past 30 days.
  • No reactive pupils.
  • Synechia of the iris to the lens after surgery or inflammation.
  • Neovascularization.
  • Axenfeld-Rieger Syndrome.
  • Iris atrophy (ICE syndrome).
  • Iris coloboma.
  • Sphincter damage due to ischemia.
  • Sphincter damage due to trauma (tears of sphincter or diffuse damage to muscle).
  • Sphincter damage due to Herpes Zoster Uveitis.
  • Sphincter damage due to high intraocular pressure.
  • Iris tumor or cyst.
  • Ectropion uvae.
  • Adie's pupil.
  • Third nerve aberrant regeneration of the iris sphincter.
  • RP patients with Optic neuropathy with the potential of producing a positive RAPD (Relative Afferent Pupillary Defect).
  • Chronic use of myotics or mydriatics.
  • Systemic medication that have affect on pupillary reflex .
  • Any condition preventing accurate measurement or examination of the pupil.

结局指标

主要结局

PLR response amplitude and latency

时间窗: single visit

次要结局

未报告次要终点

研究者

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

Dr. Ygal Rotenstreich

Head of Electrophisiology Unit, Maurice and Gabriela Goldschleger Eye Research Institute

Sheba Medical Center

研究点 (1)

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