CRYO-ROP VISUAL ACUITY CENTER

说明(调查人员摘要) 低温ROP后续视力中心的目的是 在三个月的随访中实施视功能评估 参加多中心冷冻治疗的儿童团体 用于早产儿视网膜病变(CRYO-ROP)研究。第一组 由256名儿童组成，他们发展了5个连续时钟或8个总时钟 3期早产儿视网膜病变(ROP)合并Plus病和 都是试验随机部分的参与者。第二 小组由67名儿童组成，即“特殊阈值前”小组，他们 在第3阶段的ROP中连续开发不到5个小时或总时长不到8个小时 患有PLUS疾病。这些小组将被作为 11期冷冻-ROP随访研究。第三组包括 539名出生体重低于1000克的儿童中有5名 23个学习中心。这些儿童没有发生ROP或不太严重的ROP 比其他两组的孩子更多，他们将作为一部分 冷冻-ROP自然历史后续研究。 所有三组的儿童都将接受单眼视力评估 视力、单眼对比敏感度、单眼色觉和 9岁时的立体视和单眼视力的评估 10岁时单眼视野大小。在随机化的和 特别阈值前小组，评估将由三个人进行 前往当地中心的测试员。这三个测试仪，外加两个 非旅行测试员将对患者进行评估 自然历史组。 视觉敏锐度中心将培训测试者使用的方法来评估 功能视觉，将监视测试人员的活动，因为他们 在23个中心和中心测试随机和特殊的阈值前患者 自然病史患者在五个中心，将确保质量 控制得到维护，并将参与数据分析和编写 在研究人群中与视觉功能相关的手稿。

DESCRIPTION (Investigator's Abstract) The purpose of the CRYO-ROP Follow-up Visual Acuity Center is to implement the assessment of visual function in the follow-up of three groups of children who were participants in the Multicenter Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) Study. The first group consists of 256 children who developed 5 contiguous or 8 total clock hours of stage 3 retinopathy of prematurity (ROP) with plus disease and were participants in the randomized portion of the trial. The second group consists of 67 children, the "special prethreshold" group, who developed fewer than 5 contiguous or 8 total clock hours of stage 3 ROP with plus disease. These groups will be followed as part of the Phase 11 CRYO-ROP Follow-up Study. The third group consists of 539 children with birth weights less than 1000g at five of the 23 study centers. These children developed no ROP or less severe ROP than children in the other two groups, and they will be followed as part of the CRYO-ROP Natural History Follow-up Study. Children in all three groups will receive assessments of monocular visual acuity, monocular contrast sensitivity, monocular color vision, and stereopsis at age 9 years, and assessments of monocular visual acuity and monocular visual field size at age 10 years. In the randomized and special prethreshold groups, assessments will be conducted by three Testers who travel to the local centers. These three Testers, plus two non-traveling testers, will conduct the assessments of the patients in natural history group. The Visual Acuity Center will train Testers in the methods used to assess functional vision, will monitor the activities of the Testers as they test randomized and special prethreshold patients in 23 centers and natural history patients in five centers, 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.