Assessment of Visual Function in Ophthalmic Disorders Using Virtual Visual Field Analysis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Humphrey visual field result
研究概览
简要总结
- To evaluate the accuracy of virtual visual field (VVF) headsets equipped the standard visual field software in its ability to assess visual function in various retinal, glaucoma and neuro-ophthalmic disorders by comparing retinal fundus and optic nerve images, optical coherence tomography and neuroimages to the VVF produced.
- To test the null hypothesis that VVF testing compares favorably to the gold standard, Humphrey visual field (HVF) by comparing testing time, mean sensitivity, markers of reliability including false positives and negatives and fixation losses and global indices such as mean deviation and pattern standard deviation.
详细描述
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Study Style: Prospective, Controlled Clinical Trial
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Objectives:
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To determine the capacity for a portable head-mounted virtual visual field-testing device, with capacity for remote testing, to accurately analyze visual function in various retina, neuro-ophthalmic and glaucoma disorders.
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To compare virtual visual field results with the "gold standard," Humphrey visual fields.
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Subjects: Consecutive patients already scheduled for visual fields for various retina, glaucoma and neuro-ophthalmic conditions and normal controls.
SETTING AND PROTOCOL FOR HUMAN RESEARCH:
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Location: Ophthalmology Department, Jacobi Medical Center, Bronx New York.
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Recruitment: Patients already presenting to the eye clinic or seen on the wards at Jacobi Medical Center will be offered a chance to participate as volunteers. No other active recruitment will be done.
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Retention and Dropout: Investigators will encourage patients to complete their testing. However, it will be made clear that they can drop out at any time without need to provide a reason. Dropouts will be replaced with other consenting patients.
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Protocol (Interventions and Timing):
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Consecutive patients presenting to the Jacobi eye clinic and wards who are diagnosed with neurologic, glaucoma and retina conditions and already are scheduled to have Humphrey visual field analysis, will be asked if they would like to voluntarily participate in this study.
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Interested patients will be have the study explained to them and an informed consent taken by the study resident/technician.
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The standard Humphrey visual field (HVF) will be conducted by the technician (5-10 minutes) in the usual manner.
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The option of doing the virtual fields immediately, on the same day, will be offered vs returning to conduct the test within 3 months.
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The virtual reality headset will be applied and instructions in the patient's preferred language provided through the earpiece of the virtual visual field (VVF). When the patient indicates they wish to proceed, the test will be started by the technician.
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The technician is already versed in conducting both versions of the visual field tests.
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Clinical Analysis: All fields will be stored digitally within each Health Insurance Portability and Accountability Act (HIPAA) compliant device-specific website for later analyses by respective Attendings (glaucoma, retina and neuro-ophthalmology/neurology).
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Data Collection:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with retina, glaucoma and neuroophthalmic disorders
- •Patients with normal eye exams to act as controls
- •Must be able to comprehend instructions and perform visual fields
排除标准
- •Patients <18years old
- •Patients unable to comprehend visual field instructions or unwilling to participate
- •Patients lacking a complete clinical file or lacking a specific diagnosis
结局指标
主要结局
Humphrey visual field result
时间窗: within 3 months
Gray scale pattern will reveal areas of vision loss or visual depression; this will have a numerical total deviation plot giving numbers in decibels of the points in the visual field of depressed or lost points of vision. Global indices also will be recorded; these give numerical quantification in decibel units of visual field loss. and include: mean deviation - the average of all decreased perception, pattern deviation which highlights localized losses and pattern standard deviation which quantifies the amount of loss and gauges progression.
Virtual visual field result
时间窗: with 3 months
Gray scale pattern will reveal areas of vision loss or visual depression; this will have a numerical total deviation plot giving numbers in decibels of the points in the visual field of depressed or lost points of vision. Global indices also will be recorded; these give numerical quantification in decibel units of visual field loss. and include: mean deviation - the average of all decreased perception, pattern deviation which highlights localized losses and pattern standard deviation which quantifies the amount of loss and gauges progression. Time take to complete fields and reliability indices will be recorded: fixation losses, false positives, false negatives
次要结局
- Comparison of Virtual Visual field (VVF) to Humphrey visual fields (HVF)(At end of study when we have all the data ~ one year)
研究者
Joyce Mbekeani
Associate Professor of Ophthalmology & Visual Sciences
New York City Health and Hospitals Corporation