CRYO-ROP PARTICIPATING CENTER PHASE III

这项研究的目的是研究长期的结构性和 冷冻术治疗重症视网膜病变的功能效应 早产儿(ROP)。1986年1月，体重不到1251岁的婴儿 例如，出生时首次登记参加预期检查序列 导致291名婴儿参与了一项关于 冷冻治疗指定阈值的ROP严重程度。对年龄的随访 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， 在研究第二阶段，对42个月大的婴儿进行了跟踪调查，结果表明 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。被削弱的人 治疗眼和未治疗眼之间的结果差异， 尤其是视觉敏锐度，带来了足够的不确定性， 被认为至关重要的是继续跟踪这一人群，直到 冷冻治疗对这些患者眼视觉发育的影响 童年可以牢固地建立起来。 这项研究目前正在缩小规模，跟踪所有随机的 患者(n=256)和仅有自然历史研究人群在 费城中心，婴儿期未发生ROP者104例。他们会 被跟踪到10岁，以确定是否减少了 12岁至42岁之间的数据表明冷冻治疗的好处 几个月的时间将持续到童年中期。对结果的评价和 冷冻治疗的效果将基于He的检查结果。 眼睛的后极和视力评估。除了……之外 敏锐度，视力将在10岁时通过测量 戈德曼视野检查的视野范围取决于 目前正在进行一项试点研究，以确定可行性。

The purpose of the 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 prospective examinations sequence that led to the participation of 291 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 42 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 he 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. The study is currently scaled down, following up all the randomized patients (n=256) and only the natural history study population at the Philadelphia Center who did not develop ROP as infants (n=104). They will be followed through age 10 years, to determine whether the reduction in the benefit of cryotherapy suggested by the data between ages 12 and 42 months will continue into mid-childhood. Evaluation of outcome and the effects of cryotherapy will be based on examination findings in he posterior pole of the eye and on assessment of vision. In addition to acuity, vision will be assessed at age 10 years through measurement of the extent of the visual field by Goldmann perimetry contingent on feasibility determination through a pilot study, currently underway.