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: 2888484
• 负责人: CHRIS A JOHNSON
• 金额: $ 8.79万
• 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: 1995-07-01 至 2000-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2888484
• 关键词: African American; bioimaging /biomedical imaging; clinical trials; cooperative study; evaluation /testing; glaucoma; human subject; optic disk; optic nerve; perimetry; prognosis; racial /ethnic difference; visual fields

The Ocular Hypertension Treatment Study (OHTS) is a long-term randomized multicenter clinical trial 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. 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 are randomly assigned to receive stepped medical treatment to both eyes or to close observation only to both eyes. Participants are followed for a minimum of 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 independently at the University of California, Davis and the University of California, San Diego have established that (l) SWAP is more sensitive than conventional automated perimetry for detection of early functional 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 conventional automated perimetry, (3) that the progression of SWAP deficits is approximately twice as great as for conventional automated perimetry, and (4) that early SWAP deficits in 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 describes an ancillary study to the OHTS trial that is to be performed at five of the participating OHTS Clinical Centers, in which participants will undergo SWAP testing. 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 and incidence of SWAP deficits in African American patients participating in OHTS will be evaluated to determine whether African-American ocular hypertensives have a higher prevalence and/or incidence of SWAP deficits.

眼高血压治疗研究（OHTS）是长期随机的 多中心临床试验，以确定医疗降低是否减少 眼内压力阻止或延迟青光眼光学的发作 眼部高血压受试者的神经损伤和/或视野丧失。 1,500名眼内压力大于或等于24的受试者 MM Hg，但至少一只眼睛小于或等于32毫米Hg 眼内压21毫米汞柱或更高的眼睛）和正常 两只眼睛中的视野和正常视盘被随机分配给 双眼或关闭观察 只是两只眼睛。遵循参与者至少五年 每年两次和立体镜检查带有传统的自动化元素 光盘照片每年一次。研究终点是可重现的视线 神经损伤和/或可重现的两种方法 病人的眼睛。 短波长自动化（交换）是一个新的视野测试 分离和测量短波长的灵敏度的过程 （蓝色）敏感的视觉机制通过投影大（V）蓝色 高亮度黄色背景的目标。以前的纵向 研究在加利福尼亚大学，戴维斯大学和 加州大学圣地亚哥分校已经确定（l）交换是 比传统的自动构造更敏感 青光眼中的早期功能损失，（2）眼部掉期缺陷 高血压患者和青光眼嫌疑犯可预测发作 和未来的青光眼视野损失的位置 自动化的局部，（3）交换缺陷的进展为 大约是传统自动化的两倍，并且 （4）眼部高血压患者和青光眼的早期交换缺陷 可疑嫌疑人与与 青光眼的发展，尤其是青光眼视盘拔罐。 该提案描述了OHTS试验的辅助研究 在参与的OHTS临床中心中进行的五个 参与者将接受掉期测试。这项研究的主要目标 是确定治疗与无治疗对掉期的影响 导致眼部高血压患者。特别是这个调查 将检查治疗对早期掉期可逆性的影响 缺陷，确定掉期缺陷的进展是否受到智障 治疗，以及在OHTS期间新交换缺陷的发生率是否 通过治疗减少试验。这项研究的次要目标是 确认交换可以预测的先前发现 未来的青光眼视野损失和交换的进展 缺陷是视野损失进展的两倍以上 具有常规的自动化范围。此外，患病率和 参加活动的非裔美国人患者的掉期缺陷的发生率 将对OHTS进行评估以确定是否是非裔美国人 高血压的患病率和/或交换缺陷的发生率更高。