CRYO ROP PARTICIPATING CENTER--PHASE III

CRYO ROP 参与中心--第三期

• 批准号: 2163524
• 负责人: Stephen S. Feman
• 金额: $ 1.78万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-06-01 至 1998-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2163524
• 关键词: child (0-11); color visions; cooperative study; cryotherapy; disease /disorder proneness /risk; eye disorder diagnosis; human subject; human therapy evaluation; longitudinal human study; low birth weight infant human; pediatrics; perimetry; premature infant human; retinopathy of prematurity; vision disorders; visual fields; visual perception

DESCRIPTION (Investigator's Abstract) The purpose of the proposed study is to examine the long-term structural and functional effects of cryotherapy as a treatment for severe retinopathy of prematurity (ROP). In the initial phase of the study, eyes with 5 contiguous or 8 total clock hours of stage 3 plus ROP, in 291 infants with birth weights less than 1251 g., were randomized to received cryotherapy or no cryotherapy. Follow-up to age 12 months indicated that cryotherapy reduced the incidence of unfavorable structural outcome by 45.8 percent, and the incidence of unfavorable visual acuity outcome by 37.8 percent. Based on the preliminary data, follow-up to age 42 months during Phase II of the study indicated that cryotherapy reduced the incidence of unfavorable resolution acuity outcome by 21.4 percent, and by 19.7 percent when based on measurement of recognition acuity. The present study proposes to follow patients in the randomized group and a relatively small subgroup (67) of potentially high risk patients from the Natural History study through age 10 years, to determine whether the reduction in benefit of cryotherapy noted between ages 12 and 42 months continues into mid-childhood. Evaluation of the effects of cryotherapy will be based on examination findings in the posterior pole of the eye and on assessment of visual acuity, as in Phase II. In addition, a more complete evaluation of visual function will be conducted at age 9 years, through assessment of monocular contrast sensitivity, monocular color vision, and stereopsis, and at age 10 years, through measurement of the extent of the visual field by Goldmann perimetry.

描述（研究者摘要） 建议研究的目的，是研究香港的长远结构， 冷冻疗法作为治疗严重 早产儿视网膜病变（ROP）。 在研究的初始阶段， 具有5个连续或总共8个时钟小时的阶段3加ROP的眼睛， 291名出生体重低于1251 g的婴儿，随机分配至 接受冷冻治疗或不接受冷冻治疗。 随访至12个月 表明冷冻治疗降低了不良反应的发生率， 结构性结果减少45.8%， 视力改善37.8%。 根据初步数据， 在研究的第二阶段期间随访至42个月大， 冷冻治疗降低了不良分辨率敏锐度的发生率 结果为21.4%，根据测量结果为19.7% 认知敏锐度的能力 本研究建议对随机分组的患者进行随访， 相对较小的潜在高风险患者亚组（67例）， 通过10岁的自然历史研究，以确定是否 在12至42个月之间观察到冷冻治疗的益处减少 一直持续到童年中期。 冷冻治疗效果的评估将基于检查 眼睛后极的发现和视力评估 如第二阶段一样。 此外，更全面的评价 视功能将在9岁时进行，通过评估 单眼对比敏感度、单眼色觉和立体视觉， 在10岁时，通过测量视觉的范围， Goldmann perimetry视野检查