CRYO-ROP PARTICIPATING CENTER PHASE III

研究的目的是研究长期结构和 冷冻疗法治疗严重视网膜病变的功能效果 早产儿（ROP）1986年1月，体重低于1251磅的婴儿 G.在出生时首先参加前瞻性检查序列， 导致291名婴儿参与了一项随机试验， 冷冻疗法用于ROP的指定阈值严重性。年龄跟踪 12个月表明冷冻治疗减少了不良反应的发生率， 结构性结果减少45.8%， 视力改善37.8%。根据初步数据， 在研究的第二阶段期间随访至42个月大，表明 冷冻治疗降低了不良结构结果的发生率， 39.1百分之至于视力，冷冻治疗降低了 不良的分辨率视力结果，21.4%，19.7 根据识别敏锐度的测量，减弱 治疗眼和未治疗眼之间的结果差异， 特别是对于视觉敏锐度，这引起了足够的不确定性， 被认为是至关重要的，继续跟踪这一人口，直到影响 冷冻治疗对这些患者的眼视觉发育的影响， 童年是可以建立的。 该研究目前正在缩小规模，随访所有随机 患者（n=256）和仅自然史研究人群 Philadelphia中心的患者，在婴儿期未发生ROP（n=104）。他们将 在10岁时进行跟踪，以确定是否减少 12岁到42岁之间的数据表明冷冻疗法的好处 几个月将持续到童年中期。成果评价和 冷冻治疗的效果将根据检查结果在他 眼后极和视力评估。除了 将在10岁时通过测量以下指标评估视力： 通过Goldmann视野检查的视野范围取决于 目前正在通过试点研究确定可行性。

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.