PHASE II CRYOTHERAPY FOR RETINOPATHY OF PREMATURITY

照相确定的视网膜结构的评价 为期三个月的跟踪检查的文件表明 在冷冻-ROP试验中接受治疗的眼睛获得了良好的结果。这个结果 使得对冷冻-ROP试验中的婴儿进行长期跟踪至关重要 评估手术的长期安全性和有效性，以确定 应用治疗的最佳疾病阈值，并定义 婴幼儿轻度视网膜病变的常规随访指征 早产儿。 冷冻-ROP研究的主要结果衡量标准是 视网膜结构，由一年的摄影资料确定 在冷冻治疗之后。在患者接受治疗后的一段时间内 1986年开始试验测量婴儿视觉功能的技术 已经发展到有可能添加第二个结果 在冷冻治疗后一年测量。第二个结果衡量标准是 由出纳员视力卡单眼评估的格栅视力 方法。 我们建议继续评估视网膜结构和视觉功能 冷冻-ROP试验中的婴儿额外五年随访期 为了第一次尝试将结构性变化联系起来 在ROP的急性增生期和瘢痕期均可观察到 最终影响眼睛的视觉功能。我们还将评估 推荐冷冻治疗的婴儿的长期风险/收益比 不同程度的ROP，并记录长期的眼睛状态和视力 极低出生体重儿不同程度治疗或治疗后的功能 未经处理的ROP。将考察三个具体问题： 1.眼部是否有长期的结构性或功能性后遗症 接受冷冻治疗，需要重新评估 推荐冷冻治疗的风险/收益比？ 2.对未经治疗的眼的结构和功能后遗症进行长期数据分析 ROP是否表明冷冻治疗的“门槛”应该降低？ 3.眼部结构或功能异常的发生率 轻度ROP的婴儿与没有ROP的婴儿有什么不同？如果没有， 未来的资源可以集中在对中度肥胖婴儿的随访上。 或者严重的ROP。

The evaluation of retinal structure as determined by photographic documentation at the three-month follow-up examination has indicated 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 ration 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 would require re-evaluation of the risk/benefit ratio of recommending cryotherapy? 2.Do long-term data on structural and functional sequelae in untreated eyes 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.