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临床试验/NCT01303939
NCT01303939已完成不适用

Neuroimaging Brain Changes in Glaucoma

Wills Eye2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2010年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
37
试验地点
2
主要终点
Absolute Brain Volume (Size)

研究概览

简要总结

The purpose of the study is to determine if glaucoma is associated with neurodegenerative changes in areas of the brain other than the occipital lobe. This will help guide the direction of further research in the use of neuroprotective agents in preventing or controlling such changes. The final goal is to improve the quality of life for patients with glaucoma.

详细描述

Death of retinal ganglion cells causes loss of neurons in areas other than just the visual cortex. These neurodegenerative changes decrease the patient's ability to perform the activities of daily living. Tensor-based morphometry analysis of magnetic resonance imaging (MRI) brain scans will reveal areas of cortical degeneration in glaucoma patients, and the extent of damage in these areas should correlate with patients ability to perform vision-dependent tasks, as measured by the Assessment of Ability Related to Vision (AARV).

Patients with glaucoma who were outliers in two previous studies, Assessment of Ability Related to Vision (AARV) or Assessment of Disability related to vision (ADREV), in that they had poor performance-based measure scores despite having midrange visual field scores.

Mini-Mental State Exam and T-1 weighted MRI brain scan and will be performed.

研究设计

研究类型
Interventional
分配方式
Non Randomized
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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with glaucoma who were participated in other studies Assessment of Ability Related to Vision (AARV) or Assessment of Disability Related to Vision (ADREV) and were found to be outliers in that they have poor performance-based measure scores (≤ 40) despite having midrange visual field scores (mean deviation of -6 to -20).
  • Age-, gender- and race-matched controls who do not have glaucoma, and who do not have loss of vision for any reason other than cataract or refractive error.

排除标准

  • Patients with any type of neurological disease.
  • Patients with a cognitive deficit which would affect visual functioning, as revealed by score of less than 25 in the mini mental status examination.

研究组 & 干预措施

Glaucoma Patients

Other

Patients who were outliers from two previous studies: Assessment of Ability Related to Vision (AARV) or Assessment of Disability Related to Vision (ADREV) with mini mental status exam score of 25 or higher underwent magnetic resonance imaging (MRI) of the brain to look at structures and volume.

干预措施: magnetic resonance imaging (MRI) of the brain (Diagnostic Test)

Control Patients

Other

Age, gender and race matched (to each glaucoma patient) group of healthy individuals with no ocular diseases with mini mental status exam score of 25 or higher underwent magnetic resonance imaging (MRI) of the brain to look at structures and volume.

干预措施: magnetic resonance imaging (MRI) of the brain (Diagnostic Test)

结局指标

主要结局

Absolute Brain Volume (Size)

时间窗: 2 hours

Absolute volume (size) of inferior occipital gyrus L (a location in the brain structure) is measured in cubic millimeters (mm3).

次要结局

  • Relative Volumes(2 hours)

研究者

发起方
Wills Eye
申办方类型
Other
责任方
Principal Investigator
主要研究者

George L. Spaeth MD

Principal Investigator

Wills Eye

研究点 (2)

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