CRYO-ROP FOLLOW-UP VISUAL ACUITY 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。这一结果使婴儿在冷冻-ROP中得到随访 试验对评估阿司匹林的长期安全性和有效性至关重要 程序，以确定最佳疾病阈值为 治疗的应用，并确定治疗的适应症 轻度ROP婴儿的常规随访。 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 该试验于1986年开始招收患者，该技术为4 测量婴儿的视觉功能发展到了这样一个地步 有可能在一年后增加第二个结果衡量标准 冷冻疗法。第二个测量结果是视觉敏锐度， 由Teller Acuity Card单眼评估。 我们建议继续评估视网膜结构和视力 在冷冻-ROP试验中，婴儿的功能增加了5- 一年的跟踪期，以便首次尝试 将观察到的结构变化与急性期 ROP的增生期和瘢痕期，最终 眼睛的视觉功能。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。 视觉敏锐度中心将培训八名测试员学习 评估功能视力(分辨率敏感度、识别敏感度、 和视野)，将监测研究中的儿童 测试员的活动，因为他们测试了所有随机和自然的 参与这项研究的23个中心的历史患者将 确保保持质量控制，并将参与 与视觉功能相关的稿件的数据分析和撰写 在研究人群中。

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 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 ROP. 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 intake of patients for the trial began in 1986, the technology for4 measuring visual function in infants evolved to the point that it was possible to add a second outcome measure at one year after cryotherapy. This second outcome measure is grating visual acuity, as assessed monocularly by Teller Acuity Cards. 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. The Visual Acuity Center will train eight testers in methods of assessing functional vision (resolution acuity, recognition acuity, and visual fields) of children in the study, will monitor the activities of the testers as they test all randomized and natural history patients at the 23 centers participating in the study, will assure that quality control is maintained, and will participate in data analysis and writing of manuscripts related to visual function in the study population.