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临床试验/NCT01021982
NCT01021982已完成不适用

Objective Perimetry in Normal Subjects,Glaucoma Patients and Retinitis Pigmentosa Patients .

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
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 RP and Glaucoma patients than conventional subjective perimetry.The PLR ( Pupil Light Reflex ) of the short and long wave ratio should be significantly higher in areas of visual field defects in RP and Glaucoma patients.

详细描述

Pupil light reflex will be measured by a pupillometer in response to short and long wavelength light small spot stimulus in different area of the visual field. The PRL will be measured in four quadrant, central, 10, 20, and 30 degree from the visual axis.

Stimulus duration will be 1000 ms (1 sec), with intervals of 890 ms between stimuli. The stimuli size V with light intensity of 39.8 cd-s/m2 for both short wavelength stimuli (peak 485 nm) and long wavelength stimuli (peak 620nm).

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Sign on informed consent
  • Papillary response to light.
  • Groups of : Normal , Glaucoma patients with early glaucoma damage on HVF (nasal step ect. ), Glaucoma patients with advanced glaucoma damage on HVF (arcuate , tubular vision ) and RP patients (Early VF damage , ring scotoma ) .
  • Refractive correction up to -3.5 D.

排除标准

  • Cloudy corneas.
  • Surgical intraocular ophthalmic procedure within the past 30 days.
  • Nonreactive pupils.
  • Synechia of the iris to the lens after surgery or inflammation .
  • Neovascularization.
  • Iris coloboma.
  • Sphincter damage due to ischemia or trauma (tears of sphincter or diffuse damage to muscle).
  • Sphincter damage due to high intraocular pressure .
  • Iris tumor or cyst .
  • Ectropion uvea .
  • Adie's pupil .
  • Optic neuropathy with the potential for producing a positive RAPD (Relative Afferent Pupillary Defect ).
  • Chronic use of myotics or mydriatics.
  • Systemic Medication which affect on papillary response .
  • Any condition preventing accurate measurement or examination of the pupils.

结局指标

主要结局

PLR response amplitude and latency

时间窗: Not defined yet

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

Director, Electrophysiology Clinic, Goldschleger Eye Institute

Sheba Medical Center

研究点 (1)

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