CRYO-ROP FOLLOW-UP VISUAL ACUITY CENTER

视网膜结构的评估，通过照相确定 在三个月的随访检查中， 表明在CRYO-ROP中治疗的眼睛的结局良好 审判 这一结果使得在CRYO-ROP中对婴儿的随访成为可能。 评价长期安全性和有效性的重要试验 该程序，以确定最佳疾病阈值， 治疗的应用，并定义适应症 轻度ROP婴儿的常规随访。 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， 该试验的病人开始于1986年，该技术为4 测量婴儿的视觉功能已经发展到 可以在术后一年增加第二个结局指标， 冷冻疗法 第二个结果指标是光栅视敏度， 通过泰勒视力卡进行单目评估。 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。 视力中心将培训八名测试人员， 评估功能视力（分辨敏锐度，识别敏锐度， 和视野）的儿童在研究中，将监测 测试人员的活动，因为他们测试所有随机和自然 参与研究的23家中心的病史患者将 确保质量控制得到维持，并将参与 数据分析和撰写与视觉功能相关的文稿 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.