SHORT WAVELENGTH AUTOMATED PERIMETRY IN THE OHTS TRIAL

OHTS 试验中的短波长自动视野检查

• 批准号: 6194632
• 负责人: CHRIS A JOHNSON
• 金额: $ 11.62万
• 依托单位: LEGACY EMANUEL HOSPITAL AND HEALTH CENTER
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-09-01 至 2005-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6194632
• 关键词: African American; bioimaging /biomedical imaging; biomedical automation; clinical research; clinical trials; cooperative study; diagnosis design /evaluation; diagnosis quality /standard; disease /disorder prevention /control; early diagnosis; glaucoma; human subject; human therapy evaluation; longitudinal human study; ocular hypotensive; optic disk; optic nerve; pathologic process; perimetry; prognosis; racial /ethnic difference; visual fields

The Ocular Hypertension Treatment Study (OHTS) is a long-term randomized multicenter clinical trial that began in 1994 to determine whether medical reduction of intraocular pressure prevents or delays the onset of glaucomatous optic nerve damage and/or visual field loss in ocular hypertensive subjects. More than 1,500 subjects with intraocular pressures of greater than or equal to 24 mm Hg but less than or equal to 32 mm Hg in at least one eye (with an intraocular pressure of 21 mm Hg or greater in the fellow eye), and normal visual fields and normal optic discs in both eyes were randomly assigned to receive stepped medical treatment to both eyes or to close observation only to both eyes. Participants have been followed for approximately five years with conventional automated perimetry twice yearly and stereoscopic optic disc photographs once yearly. The study endpoints are reproducible optic nerve damage and/or reproducible glaucomatous visual field loss in either eye of a patient. Short Wavelength Automated Perimetry (SWAP) is a new visual field test procedure that isolates and measures the sensitivity of short wavelength (blue) sensitive visual mechanisms by projecting large (Size V) blue targets on a high luminance yellow background. Previous longitudinal studies conducted at the University of California, Davis and the University of California, San Diego have established that (1) SWAP is more sensitive than conventional automated perimetry for detection of early losses in glaucoma, (2) SWAP deficits in ocular hypertensive patients and glaucoma suspects are predictive of the onset and location of future glaucomatous visual field loss for standard automated perimetry, (3) that the progression of SWAP deficits is approximately twice as great as for standard automated perimetry, and (4) that early SWAP deficits is ocular hypertensive patients and glaucoma suspects are correlated with other risk factors associated with the development of glaucoma, especially glaucomatous optic disc cupping. This proposal requests a 5 year extension of the original SWAP ancillary study to the OHTS trial. Since 1994, more than 350 OHTS patients have been enrolled in the SWAP ancillary study. The main objective of this study is to determine the effect of treatment versus no treatment on SWAP results in ocular hypertensive patients. In particular, this investigation will examine the influence of treatment on reversibility of early SWAP deficits, determine whether progression of SWAP deficits is retarded by treatment, and whether the incidence of new SWAP deficits during the OHTS trial are reduced by treatment. A secondary goal of this study is to confirm previous findings that SWAP can predict the onset and location of future glaucomatous visual field loss, and that progression of SWAP deficits is more than twice as rapid as progression of visual field loss with conventional automated perimetry. Additionally, the prevalence of SWAP deficits in African American patients participating in OHTS will be evaluated to determine whether African-American ocular hypertensives have a higher prevalence of SWAP deficits.

眼部高血压治疗研究（OHTS）是一项长期随机多中心临床试验，始于1994年，旨在确定眼内压力的医学降低是否阻止或延迟了眼镜神经神经损伤和/或视觉场中视野损失和/或视觉场中的视野丧失。 至少一只眼睛的1,500多名眼内压力大于或等于24 mm Hg，但小于或等于32 mm Hg的受试者（眼睛的眼内压力为21 mm Hg或更高的眼睛），正常的视野和正常视野和正常的光盘随机分配了两者，以接收踩踏的医疗治疗，以近眼观察到两只眼睛。每年两次，参与者进行了大约五年的时间，并每年两次进行立体视盘照片。 研究终点是可再现的视神经损伤和/或患者的可再现的青光眼视野损失。短波长度自动化（swap）是一种新的视野测试过程，它通过在高亮度黄色背景上投影大的（尺寸V）蓝色目标来隔离并测量短波长（蓝色）敏感的视觉机制的灵敏度。 以前在加利福尼亚大学戴维斯分校和加利福尼亚大学圣地亚哥分校进行的纵向研究已经确定，（1）互换比常规自动化周围更敏感，用于检测青光眼的早期损失，（2）互换在Ocular hypertgensial and Plaimate of Tivation of Tivation of Tivation of Tivation of Tivation of Tivation otim of Tivation of Tivation of Tivation of Tivation of Tivation of Tivation of Tivation of Tivation otim of Tivation of Tivation of Tivation of Tivation of Tivation of Tivation otim（掉期缺陷的进展大约是标准自动化周围的两倍，并且（4）早期掉期缺陷是眼部高血压患者，而青光眼嫌疑犯与其他风险因素相关，尤其是与青光眼的发展相关的风险因素，尤其是青光眼的光学盘中。该提案要求将原始的辅助研究延长为5年，以延长OHTS试验。 自1994年以来，已有350多名OHTS患者参加了辅助研究。这项研究的主要目的是确定治疗与无治疗对掉期交换的影响，导致眼部高血压患者。 特别是，这项研究将检查治疗对早期掉期缺陷可逆性的影响，确定掉期缺陷的进展是否受到治疗的阻碍，以及在OHTS试验期间新掉期缺陷的发生率是否通过治疗降低。 这项研究的次要目标是确认以前的发现，即掉期可以预测未来的青光眼视野损失的发作和位置，并且掉期缺陷的进展是通过传统自动化局部使用视野损失的进展的两倍以上。 此外，将评估参加OHTS的非裔美国人患者的掉期缺陷的患病率，以确定非裔美国人眼高血压是否具有较高的掉期缺陷患病率。