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。有效治疗需要 患者随时间进行视野检查，以监测视野丧失的进展。在许多患者中 没有进展，但当它发生时，必须尽快发现，以挽救视力 通过更积极的治疗视力实际上是稳定的患者不知道，所以他们担心 不必要的。 测量视野的常规测试太难了。他们很累，设备 他们使用的是昂贵和笨重的，仍然需要熟练的视野检查师来训练患者如何进行测试， 来监测眼球运动和病人疲劳。因此，青光眼患者通常具有视野 每年只测试一到三次。不幸的是，这些测试的结果具有很高的可变性， 测试的持续时间很短。因此，在估计疾病进展速率时存在较大误差 青光眼患者的视野，迫切需要在家里做额外的测试，以克服 数据限制。 我们开发了一种称为生动视觉视野检查（VVP-10）的测试，该测试大大增加了 患者可以在家中通过低成本的虚拟现实（VR）头戴设备使用VVP-10。 我们使用了一个新颖的任务，使测试更加用户友好。VVP-10允许患者自由移动 他们的眼睛，并确切地知道什么时候刺激会出现。它在每次刺激后都会给病人反馈， 让测试更像是电子游戏患者可以选择猜测或不猜测，因为猜测 不会影响测试结果。在该项目的第一阶段，我们证明了可行性， 老年青光眼患者可以在家中进行测试，而无需亲自培训。结果与 传统的测试，我们的数学模型表明，采取一组10测试一年四次， 可以减少一半以上的月数需要检测快速进展。在此直接向 第二阶段项目，我们将使测试更容易执行，优化收集的数据质量， 验证VVP-10可以将检测快速进展所需的月数减少一半。 这项新的测试是由Vivid Vision公司开发的，一家位于旧金山弗朗西斯科的七岁公司， 约该公司销售的双目视觉治疗产品被全球350家诊所使用。它的专长是 心理物理学、VR游戏软件工程、符合HIPAA标准的远程医疗、知识产权保护、市场营销、 和销售UCSF医学院和纽约大学医学院的主要青光眼专家 已经加入该团队，在65名青光眼患者中进行为期一年的VVP-10多中心研究。