MULTICENTER CRYOTHERAPY FOR RETINOPATHY OF PREMATURITY

据估计，将有2100名婴儿受到瘢痕性肺炎的影响 美国每年都有早产儿视网膜病变(ROP)，有许多 世界上其他国家发生的病例更多。1979年， 美国因ROP失明的婴儿数量约为546人，而Numbmer 据信一直在稳步增长。陈旧性唇裂的外科治疗 发生在ROP晚期的视网膜脱离尚未得到证实 成功。 据推测，视网膜缺血组织的消融可以使 或者终止变态的视网膜前血管增殖，就像在 糖尿病眼病。有报道称，无论是光凝还是冷冻凝聚 外周视网膜有一些好处已经出现了不止 10年了，但有足够的治疗失败或 在接受冷冻治疗时须谨慎接受怀疑对眼睛造成的伤害 作为有效的治疗方法。不幸的是，没有一份积极的报告包含 接受治疗的眼睛数量足以产生统计上有效的 信息。大多数研究都是回溯性的，并没有随机选择患者。 他们有相似程度的ROP。使用的各种分类方案 使研究无法进行比较。众所周知，令人印象深刻的 视网膜病变的分期可以退化并离开眼睛，而不会严重 后遗症，只有一小部分ROP的眼睛会失明 在童年时期。 最近制定的《ROP国际分类》现在允许 协作审判，案件识别一致，登记人数 疾病的统一分期和观察员之间的数据比较 不同的地点。目前的建议是随机的、前瞻性的 经巩膜外冷凝治疗安全性和有效性的多中心试验 某些视网膜病变患者的外周视网膜损害 早产(ROP)，延缓急性疾病向严重疾病的进展 瘢痕性晶状体后纤维增生症(RLF)分级。 所有符合条件的婴儿(出生体重低于1251克，存活)的数据 28天)将进行前瞻性累积，以供描述性分析 确定ROP发展过程中的因素，例如位置、范围和 有无“加”病(ROP国际分类) 它们对预后有一定的影响。据估计，有6000到7000名婴儿必须 被跟踪，以确定为冷冻治疗候选者的所有婴儿 疾病进展到ROP的“临界值”(在第5章中定义)。 在估计的300至400名门槛婴儿中，约有80%需要 被随机进行这项研究的人预计会有两种疾病影响 眼睛对称。在这些手术中，一只眼睛将接受冷冻治疗，而 另一只眼睛将不接受治疗，治疗的眼睛在 随机的。20%受不对称影响的临界儿将只有 第一眼到达阈值随机分配给冷冻治疗或 控制力。 冷冻治疗的疗效将通过治疗前后的比较来判断。 对照眼分别随访3个月和1年。这件事会做到的 在一家摄影阅读中心对照片进行蒙面评估。

An estimated 2,100 infants will be affected by the cicatricial form of Retinopathy of Prematurity (ROP) annually in the United States, with many more cases occurring in other countries throughout the world. In 1979, the number of U.S. infants blinded by ROP was approximately 546, and the nubmer is believed to have been increasing steadily. Surgical treatment of the retinal detachments that occur in advanced stages of ROP has not proven successful. It is hypothesized that ablation of ischemic retinal tissue could minimize or terminate the perverted pre-retinal vasoproliferation, as it does in diabetic eye disease. Reports that either photo- or cryo-coagulation of the peripheral retina have some benefit have been appearing for more than 10 years, yet there have been sufficient reports of treatment failure or suspected harm to treated eyes to warrant caution in accepting cryotherapy as valid treatment. Unfortunately, none of the positive reports contain sufficient numbers of treated eyes to produce statistically valid information. Most studies are retrospective and do not randomize patients who have similar degrees of ROP. The various classification schemes used make comparison of studies impossible. It is well known that impressive stages of retinopathy can regress and leave the eye without serious sequellae, and only a small minority of eyes with ROP go on to blindness during childhood. The recently developed International Classification of ROP now permits a collaborative trial, with consistent identification of cases, enrollment of uniform stages of the disease and comparison of data among observers at different locations. The present proposal is for a randomized, prospective multicenter trial of the safety and efficacy of trans-scleral cryotherapy of the peripheral retina in certain patients with retinopathy of prematurity (ROP), in retarding progression of the acute disease to severe grades of cicatricial retrolental fibroplasia (RLF). Data on all eligible infants (birth weight less than 1251 grams, surviving 28 days) will be prospectively accumulated for descriptive analyses to identify factors in the development of ROP, such as location, extent, and presence or absence of "plus" disease (International Classification of ROP) which play a role in prognosis. An estimated 6,000 to 7,000 infants must be followed, to identify as cryotherapy candidates all infants in whom the disease progresses to a "threshold" (defined in chapter 5) severity of ROP. Approximately 80% of the estimated 300 to 400 threshold infants required to be randomized for this study are expected to have disease affecting the two eyes symmetrically. In these, one eye will receive cryotherapy and the other eye will receive no treatment, the treated eye being selected at random. The 20% asymmetrically affected threshold infants will have only the first eye reaching threshold randomly allocated to cryotherapy or control. Efficacy of cryotherapy will be judged by comparison of the treated vs. the control eyes at three months and one year of follow-up. This will be done by masked evaluation of photographs at a Photograph Reading Center.