CRYO-ROP FOLLOW-UP CLINICAL CTR

CRYO-ROP 后续临床 CTR

• 批准号: 3559518
• 负责人: RAND SPENCER
• 金额: $ 1.26万
• 依托单位: BAYLOR RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 1986
• 资助国家: 美国
• 起止时间: 1986-06-01 至 1994-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3559518
• 关键词: blindness; case history; cooperative study; cryotherapy; disease /disorder prevention /control; human subject; human therapy evaluation; longitudinal human study; low birth weight infant human; 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.

通过照相确定的视网膜结构评估 三个月后续检查的文件已 表明在 CRYO-ROP 治疗的眼睛中取得了良好的结果 审判。 这一结果使得对婴儿的长期随访 CRYO-ROP 试验对于评估长期安全性和 程序的功效，以确定最佳的疾病 应用治疗的阈值，并定义 轻度视网膜病变婴儿常规随访的指征 的早产。 CRYO-ROP 研究的主要结果指标是状态 通过照相确定的视网膜结构 冷冻治疗后一年的记录。 自从那段时间以来 该技术于 1986 年开始招募患者进行试验 用于测量婴儿视觉功能的技术已经发展到了这样的程度 可以在一次结果测量中添加第二个结果测量 冷冻治疗后一年。 第二个结果指标令人震惊 视力，通过柜员视力卡进行单眼评估 方法。 我们建议继续评估视网膜结构和视觉 CRYO-ROP 试验中的婴儿功能另外五次 年随访期，以便首次尝试 将急性期观察到的结构变化关联起来 ROP 的增殖期和疤痕期，最终 眼睛的视觉功能。 我们还将评估长期 推荐对患有以下疾病的婴儿进行冷冻治疗的风险/效益比 不同程度的 ROP 并记录长期眼睛状态 极低出生体重儿视功能的不同程度 治疗或未治疗的 ROP 程度。 三个具体问题将 被检查： 1. 是否存在长期的结构性或功能性眼部后遗症 接受冷冻疗法治疗的眼睛可能需要重新评估 推荐冷冻疗法的风险/效益比如何？ 2. 收集有关结构和功能后遗症的长期数据 未经处理的 ROP 表明，“阈值” 冷冻疗法应该降低吗？ 3. 眼部结构性或功能性病变的发生率 轻度 ROP 婴儿的异常情况与普通婴儿不同 没有 ROP 的婴儿？ 如果没有，未来的资源可能会集中在 对患有中度或重度 ROP 的婴儿进行随访。