CYRO-ROP PARTICIPATING CENTER

CYRO-ROP 参与中心

• 批准号: 3559301
• 负责人: GARY L ROGERS
• 金额: $ 23.29万
• 依托单位: CHILDREN'S HOSPITAL (COLUMBUS)
• 依托单位国家: 美国
• 财政年份: 1985
• 资助国家: 美国
• 起止时间: 1985-09-30 至 1994-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3559301
• 关键词: blindness; case history; cooperative study; cryotherapy; disease /disorder prevention /control; human subject; human therapy evaluation; longitudinal human study; pediatrics; premature infant human; prognosis; retina disorder; vision tests

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.

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 这一结果使得对婴儿的长期随访成为可能。 2010-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， 冷冻治疗一年后。 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试验中的207名婴儿中， 五年随访期，以便首次尝试 为了将在急性和慢性脑损伤中观察到的结构变化 ROP的增殖和瘢痕形成阶段， 眼睛的功能。 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. 是否有长期的结构性或功能性眼部后遗症 在17只接受冷冻治疗的眼睛中， 推荐冷冻治疗的风险/效益比的评估？ 2. 做283例结构和功能后遗症的长期数据 未治疗的ROP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 98例轻度ROP婴儿与63例轻度ROP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。