CRYO-ROP PARTICIPATING CENTER--PHASE III

CRYO-ROP 参与中心--第三期

• 批准号: 2161166
• 负责人: RAND SPENCER
• 金额: $ 1.26万
• 依托单位: TEXAS RETINA ASSOCIATES, INC.
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-09-30 至 1998-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2161166
• 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 grams, were randomized to receive cryotherapy or not 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 structural outcome by 39.1 percent. As for vision, 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 Stud 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 acuity will be conducted at age 9 years, through assessment of monocular contrast sensitivity, 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."

说明(调查人员摘要) 他说：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， 具有5个连续或8个总时钟小时的阶段3加上ROP，in 291名出生体重小于1251克的婴儿被随机分为 接受或不接受冷冻治疗。随访至12个月大的婴儿 表明冷冻治疗降低了不良反应的发生率。 结构性结果增加45.8%，不利因素的发生率 视力提高37.8%。根据初步数据， 在研究的第二阶段，对42个月大的婴儿进行的跟踪调查表明 冷冻治疗通过以下方式减少不良结构结局的发生率 39.1%。在视力方面，冷冻治疗降低了 不良分辨率敏锐度结果分别下降21.4%和19.7% 基于识别敏锐度的测量时的百分比。 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岁的自然历史研究，来确定是否 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，还将进行更全面的视力评估 在9岁时，通过单眼对比敏感度评估， 单眼对比敏感度、单眼色觉和立体视觉， 在10岁时，通过测量视力范围 戈德曼视野测度仪的视野。