CRYO ROP PARTICIPATING CENTER--PHASE III

描述（研究者摘要） 拟议研究的目的是检查长期结构性 冷冻疗法作为治疗严重 早产儿视网膜病变（ROP）。 在研究的初始阶段， 在291只眼中，有5个连续或8个总时钟小时的阶段3加ROP， 出生体重小于1251克的婴儿，被随机分配到 接受或不接受冷冻治疗。 随访至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， 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， 本研究建议对随机分组的患者进行随访， 相对较小的潜在高风险患者亚组（67例）， 自然历史研究通过年龄10年，以确定是否 在12岁至42岁之间，冷冻治疗的益处减少 几个月的时间一直持续到童年中期。 的效果评价 冷冻疗法将基于后极部的检查结果 眼睛和视力评估，如在第二阶段。 在 此外，还将对视力进行更全面的评估 在9岁时，通过评估单眼对比敏感度， 单眼对比敏感度、单眼色觉和立体视觉， 在10岁时，通过测量视觉的范围， Goldmann perimetry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 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 Study 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.