CRYOTHERAPY FOR ROP PARTICIPATING CENTER

视网膜结构的评估，通过照相确定 三个月随访检查时的记录 表明在CRYO-ROP中治疗的眼睛的结局良好 审判 这一结果使得对婴儿的长期随访成为可能。 CRYO-ROP试验对于评估长期安全性和 该程序的有效性，以确定最佳的疾病 治疗应用的阈值，并定义 轻度视网膜病变婴儿常规随访的适应症 早产儿 CRYO-ROP研究的主要结局指标是 视网膜结构，如通过照相确定的 冷冻治疗后一年的记录。 在这段时间里， 该试验的患者开始于1986年， 测量婴儿视觉功能的方法已经发展到 有可能在一年内增加第二项成果措施， 冷冻治疗后一年。 这第二个结果的衡量标准是光栅 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 在CRYO-ROP试验中， 一年的随访期，以便首次尝试 将急性和慢性炎症中观察到的结构变化 ROP的增殖期和瘢痕形成期， 眼睛的视觉功能。 我们还将评估长期 推荐冷冻治疗婴儿的风险/受益比 不同程度的ROP，并记录长期的眼睛状态， 极低出生体重儿的视觉功能 处理或未处理的ROP的程度。 三个具体问题将 审查： 1. 是否有长期的结构或功能性眼部后遗症 在接受冷冻治疗的眼睛中，可能需要重新评估 推荐冷冻疗法的风险/收益比 2. 做长期的结构和功能后遗症的数据， 未治疗的ROP患者的眼睛表明， 冷冻疗法应该降低吗？ 3. 是结构性还是功能性眼部病变的发生率 轻度ROP的婴儿与轻度ROP的婴儿相比， 没有ROP的婴儿？ 如果没有，今后的资源可集中用于 对患有中度或重度ROP的婴儿进行随访。

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.