CRYO ROP PARTICIPATING CENTER--PHASE III

描述（研究者摘要） 建议研究的目的，是研究香港的长远结构， 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 g的婴儿随机接受 冷冻治疗或不冷冻治疗。随访至12个月，结果表明， 冷冻治疗降低了不良结构结果的发生率， 45.8百分比和不良视力结局的发生率， 37.8百分之 根据初步数据，随访至12个月龄 在第二阶段的研究表明，冷冻治疗减少了 不良结构性结局发生率降低39.1%。 至于 冷冻治疗降低了视力不良结局的发生率 21.4%，19.7%，根据测量， 识别敏锐度 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，还将进行更全面的视觉功能评估 在9岁时，通过评估单眼对比敏感度， 单眼色觉和立体视觉，并在10岁时，通过 通过戈德曼视野计测量视野范围。 自然史亚组出生时体重不足1000克， 将提供数据来研究结构性和功能性 由于早产和/或ROP导致的眼部异常。 全眼 检查将在9岁和10岁时进行。 进一步发展 还将在10岁时收集状况数据。

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 receive 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 12 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 acuity outcome by 21.4 percent, and 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 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. The natural history subgroup, who weighed less than 1000 grams at birth, will provide data to study the incidence of structural and functional ocular abnormalities due to prematurity and/or ROP. Complete eye examinations will be done at age 9 and 10 years. Further developmental status data will also be collected at age 10 years.