CRYO-ROP PARTICIPATING CENTER

CRYO-ROP 参与中心

• 批准号: 3551729
• 负责人: CHARLES C BARR
• 金额: $ 0.98万
• 依托单位: UNIVERSITY OF LOUISVILLE
• 依托单位国家: 美国
• 财政年份: 1985
• 资助国家: 美国
• 起止时间: 1985-09-30 至 1994-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3551729
• 关键词: blindness; case history; cooperative study; cryotherapy; disease /disorder prevention /control; human subject; human therapy evaluation; longitudinal human study; pediatrics; premature infant human; prognosis; retina disorder; vision tests

The evaluation of retinal structure as determined by photographic documentation at the three month follow-up examination has indicated a favorable outcome in eyes treated in the CRYO-ROP trial. This outcome makes long-term follow-up of infants in the CRYO-ROP trial essential to evaluate the long-term safety and efficacy of the procedure, to determine the optimal disease threshold for application of the therapy, and to define the indications for routine follow-up of infants with mild retinopathy of prematurity. The primary outcome measure of the CRYO-ROP study was the status of the retinal structure, as determined by photographic documentation at one year after cryotherapy. During the time since the intake of patients for the trial began in 1986 the technology for measuring visual function in infants has evolved to the point that it has been possible to add a second outcome measure at one year after cryotherapy. This second outcome measure is grating visual acuity, as assessed monocularly by the Teller Acuity Card method. We propose to continue to evaluate retinal structure and visual function in infants in the CRYO-ROP trial for an additional five year follow-up period in order to attempt for the first time to correlate the structural changes observed in both the acute proliferative and the scarring phases of ROP with the eventual visual function of the eye. We will also evaluate the long term risk/benefit ratio of recommending cryotherapy in infants with differing degrees of ROP and document the long term eye status and visual function of very low birthweight infants with varying degrees of treated or untreated ROP. Three specific questions will be examined: 1. Are there long term structural or functional ocular sequelae in eyes treated with cryotherapy that could require re-evaluation of the risk/benefit ratio of recommending cryotherapy? 2. Do long term data on structural and functional sequelae in untreated eves with ROP indicate that the "threshold" for cryotherapy should be lowered? 3. Is the incidence of structural or functional ocular abnormalities any different in infants with mild ROP than in infants with no ROP? If not, future resources could be focused on follow-up of infants who have moderate or severe ROP.

照相确定的视网膜结构的评价 文件在三个月的跟踪检查中有 表明冷凝器治疗眼的效果良好。 审判。这一结果使得对婴幼儿的长期随访 冷冻-ROP试验对评估长期安全性和 该程序的疗效，以确定最佳疾病 治疗应用的门槛，并定义 婴幼儿轻度视网膜病变常规随访的适应证 早产儿的。 冷冻-ROP研究的主要结果衡量标准是 视网膜结构的，由照相确定的 冷冻治疗后一年的记录。在那之后的时间里 这项技术于1986年开始接受患者参与试验。 为了测量婴儿的视觉功能已经进化到了 已经有可能在一处添加第二个结果度量 冷冻治疗后一年。这第二个结果衡量标准是刺耳的。 视觉敏锐度，由出纳员视力卡单眼评估 方法。 我们建议继续评估视网膜结构和视力 在另外五个冷冻-ROP试验中婴儿的功能 一年的跟踪期，以便首次尝试 将观察到的结构变化与急性期 ROP的增生期和瘢痕期，最终 眼睛的视觉功能。我们还将评估长期 推荐冷冻治疗的婴儿的风险/收益比 不同程度的ROP，并记录长期的眼睛状态和 极低出生体重儿视功能的变化 已处理或未处理的ROP的程度。将有三个具体问题 被检查： 1.是否有长期的结构性或功能性眼后遗症 接受冷冻治疗的眼睛可能需要重新评估 推荐冷冻治疗的风险/收益比？ 2.做关于结构和功能后遗症的长期数据 未经治疗的ROP EWS表明， 冷冻治疗应该降低吗？ 3.结构眼或功能性眼的发生率 轻度ROP婴儿的异常与正常婴儿有什么不同 没有ROP的婴儿？如果不是，未来的资源可以集中在 对中、重度ROP婴儿的随访。