CRYO ROP PARTICIPATING CENTER--PHASE III

CRYO ROP 参与中心--第三期

• 批准号: 2159967
• 负责人: GARY L ROGERS
• 金额: $ 2.01万
• 依托单位: CHILDREN'S HOSPITAL (COLUMBUS)
• 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/2159967
• 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 receive 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 12 months during Phase II of the study indicated that cryotherapy reduced the incidence of unfavorable structural outcome by 39.1 percent. As for vision, cryotherapy reduced the incidence of unfavorable acuity outcome by 21.4 percent, and 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 the benefit of cryotherapy seen 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. The natural history subgroup, who weighed less than 1000 grams at birth, will provide data to study the incidence of structural and functional ocular abnormalities due to prematurity and/or ROP. Complete eye examinations will be done at age 9 and 10 years. Further developmental status data will also be collected at age 10 years.

说明(调查人员摘要) 建议研究的目的是研究香港的长远结构 冷冻治疗对重症急性胰腺炎的功能影响 早产儿视网膜病变(ROP)。在研究的初始阶段， 眼睛连续5个或8个总时钟小时的阶段3加上ROP，291 出生体重小于1251克的婴儿被随机接受 不管是不是冷冻治疗。对12个月的随访表明 冷冻治疗通过以下方式减少不良结构结局的发生率 45.8%和不良视力结局的发生率 37.8%。根据初步数据，随访至12个月龄 在第二阶段的研究中表明，冷冻治疗降低了 不良结构结果发生率下降39.1%。至于 视力、冷冻治疗降低了不良视力结局的发生率 增长21.4%，基于 识别敏锐度。 本研究建议对随机组中的患者进行跟踪调查，并 潜在高危患者的相对较小的亚组(67人) 通过10年的自然历史研究，来确定 12岁至42岁之间的冷冻治疗益处减少 几个月的时间一直持续到童年中期。项目效果的评估 冷冻治疗将基于后极的检查结果。 和视力评估，如在第二阶段。 此外，还将对视觉功能进行更全面的评估 在9岁时，通过单眼对比敏感度评估， 单眼色觉和立体视觉，在10岁时， 用Goldmann视野计测量视野范围。 自然历史亚组出生时体重不到1000克， 将为研究结构性和功能性的发病率提供数据 早产和/或ROP引起的眼部异常。完全眼 考试将在9岁和10岁进行。进一步发展 状态数据也将在10岁时收集。