CRYO-ROP HEADQUARTERS - 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)。1986年1月，体重较轻的婴儿 在出生时，他们第一次参加了一项前瞻性的考试 导致291名这样的婴儿参与了一项 冷冻治疗指定阈值严重程度的随机试验 ROP。对12个月龄的随访表明，冷冻治疗降低了 不良结构结果的发生率增加45.8%， 不良视力结局发生率为37.8%。基座 根据初步数据，在第二阶段对12个月龄的婴儿进行随访 研究表明，冷冻治疗降低了不良反应的发生率。 结构性成果增加39.1%。至于视力，冷冻治疗减少了 不良分辨率视力结局发生率为21.4%， 当基于识别敏锐度的测量时，下降了19.7%。这个 治疗眼和未治疗眼之间的结果差异缩小 眼睛，尤其是视力，带来了足够的不确定性， 继续跟踪这些人口被认为是至关重要的，直到 冷冻治疗对这些患者眼部视觉发育的影响 童年可以牢固地建立起来。 有必要将这种新流行的疗法应用于临床。 透视。注册的儿童代表了一个独特的群体，在这个群体中 对照组为对照眼。目前的建议 会继续跟随随机化的患者和相对较小的 潜在高危患者的额外亚组(67人)(世卫组织几乎 有资格参加治疗试验)到10岁，以确定 数据表明冷冻治疗的益处是否减少 12个月至12个月之间的婴儿将持续到儿童中期。 冷冻治疗的结果和效果的评估将基于 眼后极检查结果及评估 远见卓识。除了敏锐度，9岁时还将进行视力评估 在单目对比敏感度、单目色觉方面，以及 立体视；在10岁时，通过测量 戈德曼视野计视野检查。

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 January 1986, infants weighing less than 1251 g. at birth were first enrolled in a prospective examinations sequence that led to the participation of 291 such infants in a randomized trial of cryotherapy for a specified threshold severity of ROP. 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 indicates 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 diminished outcome difference between the treated eyes and the untreated eyes, particularly for visual acuity, raises sufficient uncertainty that it is deemed vital to continue following this population until the impact of cryotherapy on ocular visual development in these patients through childhood can be firmly established. It is necessary to place this newly popular therapy into clinical perspective. The enrolled children represent a unique group in which a control group of eyes is available for comparison. The present proposal would continue to follow the randomized patients and a relatively small additional subgroup (67) of potentially high risk patients (who nearly qualified for the therapy trial) through age 10 years, to determine whether the reduction in the benefit of cryotherapy suggested by the data between ages 12 and 12 months will continue into mid-childhood. Evaluation of outcome and the effects of cryotherapy will be based on examination findings in the posterior pole of the eye and on assessment of vision. In addition to acuity, vision will be assessed at age 9 years in terms 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.