Clustered home assessment of visual fields in patients with glaucoma

青光眼患者视野的集群家庭评估

• 批准号: 10698909
• 负责人: BENJAMIN T BACKUS
• 金额: $ 83.89万
• 依托单位: VIVID VISION, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-30 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10698909
• 关键词: 7 year old; Agreement; Algorithms; American; Binocular Vision; Blindness; Clinic; Clinical; Clinical Trials; Cognitive; Computer software; Data; Data Collection; Data Set; Devices; Diagnosis; Diagnostic; Disease Progression; Elderly; Equipment; Eye; Eye Movements; FDA Emergency Use Authorization; Fatigue; Feedback; Frequencies; Glaucoma; Health Insurance Portability and Accountability Act; Home; Insurance; Location; Marketing; Measurement; Measures; Medical; Medicare; Methods; Modeling; Modernization; Monitor; Names; Outcome; Patient Education; Patients; Pattern; Perimetry; Persons; Phase; Physicians; Play; Preparation; Procedures; Psychophysics; Sales; Sampling; San Francisco; Screening procedure; Severities; Site; Small Business Innovation Research Grant; Software Engineering; Source; Specialist; Stimulus; Structure; System; Telemedicine; Test Result; Testing; Therapeutic; Time; Training; Video Games; Vision; Visual Fields; aggressive therapy; blind; clinical efficacy; cognitive ability; cost; data exchange; design; effective therapy; field study; home test; improved; mathematical model; medical schools; novel; prevent; rapid detection; sample fixation; skills; standard of care; tool; usability; user-friendly; virtual reality game; virtual reality headset

Project summary/abstract Glaucoma is the second leading cause of irreversible vision loss in Americans. Effective treatment requires the patient to take visual field tests over time, to monitor for progression of visual field loss. In many patients there is no progression, but when it occurs it must be detected as quickly as possible in order to save vision by using a more aggressive treatment. Patients whose vision is actually stable don’t know it, so they worry unnecessarily. Conventional tests to measure visual fields are too difficult to take. They are fatiguing and the equipment they use is expensive and bulky A skilled perimetrist is still required to train the patient how to take the test and to monitor for eye movements and patient fatigue. As a result, glaucoma patients typically have a visual field test only one to three times a year. And unfortunately, the results of these tests have high variability due to the necessarily short duration of the test. Thus, there is large error when estimating the rate of disease progression from visual fields in a patient with glaucoma, and an urgent need to do additional testing at home to overcome the data limitation. We developed a test, called Vivid Vision Perimetry (VVP-10), that substantially increases the quantity of visual field data a patient can collect. Patients take VVP-10 at home on a low-cost virtual reality (VR) headset. We have made the test much more user-friendly, using a novel task. VVP-10 allows the patient to freely move their eyes and to know exactly when stimuli will appear. It gives feedback to the patient after every stimulus , and makes the test more like a video game. Patients have the option of guessing or not, because guessing does not affect the test outcome. During Phase I of this project, we demonstrated feasibility by showing that elderly glaucoma patients can perform the test at home without in-person training. The results agreed well with conventional tests, and our mathematical models suggest that taking a cluster of 10 tests four times a year could reduce by more than half the number of months needed to detect rapid progression. In this Direct to Phase II Project, we will make the test still easier to perform, optimize the quality of the data collected, and verify that VVP-10 can reduce by half the number of months needed to detect rapid progression. The new test is being developed by Vivid Vision, Inc., a seven-year-old company based in San Francisco, CA. The company sells a binocular vision treatment product used by 350 clinics worldwide. It has expertise in psychophysics, software engineering for VR games, HIPAA-compliant telemedicine, IP protection, marketing, and sales. Leading glaucoma specialists at the UCSF School of Medicine and the NYU School of Medicine have joined the team to carry out a one-year, multi-site study of VVP-10 in 65 patients with glaucoma.

项目概要/摘要 青光眼是美国人不可逆视力丧失的第二大原因，需要有效的治疗。 随着时间的推移，患者需要进行视野检查，以监测许多患者视野丧失的进展情况。 没有进展，但当发生时必须尽快检测到以挽救视力 通过使用更积极的治疗，视力实际上稳定的患者不知道这一点，所以他们担心。 不必要的。 测量视野的传统测试太难进行，而且设备很疲劳。 他们使用的设备昂贵且笨重，仍然需要熟练的视野检查员来培训患者如何进行测试和 监测眼球运动和患者疲劳程度。因此，青光眼患者通常有视野。 不幸的是，这些测试的结果每年只进行一到三次。 测试持续时间必然较短，因此，在估计疾病进展速度时存在较大误差。 青光眼患者的视野，并且迫切需要在家进行额外的检查以克服 数据限制。 我们开发了一项名为 Vivid Vision Perimetry (VVP-10) 的测试，可大幅增加 患者可以通过低成本虚拟现实 (VR) 耳机在家中使用 VVP-10 收集视野数据。 我们使用新颖的 VVP-10 使测试变得更加用户友好，允许患者自由移动。 他们的眼睛并准确地知道刺激何时会出现，它会在每次刺激后向患者提供反馈， 并使测试更像是一个电子游戏，患者可以选择猜测或不猜测，因为猜测。 不影响测试结果 在该项目的第一阶段，我们通过证明了可行性。 老年青光眼患者无需亲自培训即可在家中进行测试，结果与预期相符。 传统测试，我们的数学模型建议每年进行四次 10 项测试 可以将检测快速进展所需的月数减少一半以上。 第二阶段项目，我们将使测试更容易执行，优化收集的数据的质量，以及 验证 VVP-10 可以将检测快速进展所需的月数减少一半。 这项新测试由 Vivid Vision, Inc. 开发，这是一家位于旧金山、已有七年历史的公司， CA. 该公司销售的双眼视力治疗产品已被全球 350 家诊所使用。 心理物理学、VR 游戏软件工程、符合 HIPAA 的远程医疗、知识产权保护、营销、 加州大学旧金山分校医学院和纽约大学医学院的领先青光眼专家。 已加入该团队，对 65 名青光眼患者进行了为期一年的 VVP-10 多中心研究。