PHASE II CRYOTHERAPY FOR RETINOPATHY OF PREMATURITY

视网膜结构的评估，通过照相确定 三个月随访检查的文件表明， 在CRYO-ROP试验中治疗的眼睛中获得了有利的结局。 这一结果 因此，在CRYO-ROP试验中对婴儿进行长期随访至关重要， 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 轻度视网膜病变婴儿常规随访的适应症 早产 CRYO-ROP研究的主要结果指标是 视网膜结构，通过1年时的照片文件确定 冷冻治疗后 在接收患者后的一段时间内， 1986年开始试验测量婴儿视觉功能的技术， 已经发展到可以增加第二种结果的地步 在冷冻治疗后一年测量。 第二个结果指标是 光栅视力，通过Teller视力卡进行单眼评估 法 我们建议继续评估视网膜结构和视觉功能， CRYO-ROP试验中的婴儿额外5年随访期 为了第一次尝试将结构变化 在ROP的急性增殖期和瘢痕形成期均观察到 与眼睛的最终视觉功能有关。 我们还将评估 推荐冷冻治疗婴儿的长期风险/效益比 不同程度的ROP，并记录长期的眼睛状态和视觉 功能极低出生体重儿与不同程度的治疗或 未处理的ROP。 将审查三个具体问题： 1.眼睛是否有长期的结构或功能性后遗症 冷冻治疗，这将需要重新评估 推荐冷冻治疗的风险/收益比？ 2.未治疗眼的结构和功能后遗症的长期数据 与ROP表明，"阈值"冷冻治疗应降低？ 3.结构或功能性眼部异常的发生率是否 有轻度ROP的婴儿与无ROP的婴儿有何不同？ 如果没有的话， 未来的资源可以集中在对患有中度抑郁症的婴儿的随访上。 或严重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.