CRYO ROP PARTICIPATING CENTER--PHASE III

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， 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 接受过冷冻治疗或没有接受过冷冻治疗。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 冷冻治疗降低了不良分辨敏锐度的发生率。 结果减少21.4%，根据测量结果减少19.7% 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 冷冻治疗的益处在12至42个月龄之间减少 一直持续到童年中期。 冷冻治疗效果的评估将以检查为基础 眼后极部的发现和视力评估 敏锐度，如在第二阶段。此外，更全面的评估 视觉功能将在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，通过测量视力范围 戈德曼视野测量仪的视野。

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.