CYRO-ROP PARTICIPATING CENTER

照相确定的视网膜结构的评价 在为期三个月的跟踪检查中，文件显示 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 CRY0-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 冷冻-ROP试验中207名婴儿的功能 五年的随访期，以便第一次尝试 为了将观察到的结构变化与急性脑脊髓炎 增生期和瘢痕期ROP最终视力 眼睛的功能。我们还将评估长期的 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 在接受冷冻治疗的17只眼中，需要再次 推荐冷冻治疗的风险/收益比的评估？ 2.在283做结构和功能后遗症的长期数据 ROP未经治疗的眼睛表明 冷冻治疗应该降低吗？ 3.结构眼或功能性眼的发生率 98例轻度ROP患儿的异常情况与63例有无差异 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。

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 CRY0-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 207 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 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 birth weight 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 17 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 283 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 98 infants with mild ROP than in 63 infants with no ROP? If not, future resources could be focused on follow-up of infants who have moderate or severe ROP.