CRYO-ROP PARTICIPATING CENTER--PHASE III

CRYO-ROP 参与中心--第三期

• 批准号: 2159962
• 负责人: CHARLES C BARR
• 金额: $ 0.35万
• 依托单位: UNIVERSITY OF LOUISVILLE
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-06-01 至 1998-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2159962
• 关键词: child (0-11); color visions; cooperative study; cryotherapy; disease /disorder proneness /risk; eye disorder diagnosis; human subject; human therapy evaluation; longitudinal human study; low birth weight infant human; pediatrics; perimetry; premature infant human; retinopathy of prematurity; vision disorders; visual fields; visual perception

DESCRIPTION (Investigator's Abstract) The purpose of the proposed study is to examine the long-term structural and functional effects of cryotherapy as a treatment for severe retinopathy of prematurity (ROP). In the initial phase of the study, eyes with 5 contiguous or 8 total clock hours of stage 3 plus ROP, in 291 infants with birth weights less than 1251 grams, were randomized to receive cryotherapy or not cryotherapy. Follow-up to age 12 months indicated that cryotherapy reduced the incidence of unfavorable structural outcome by 45.8 percent and the incidence of unfavorable visual acuity outcome by 37.8 percent. Based on the preliminary data, follow-up to age 42 months during Phase II of the study indicated that cryotherapy reduced the incidence of unfavorable structural outcome by 39.1 percent. As for vision, cryotherapy reduced the incidence of unfavorable resolution acuity outcome by 21.4 percent, and by 19.7 percent when based on measurement of recognition acuity. The present study proposes to follow patients in the randomized group and a relatively small subgroup (67) of potentially high risk patients from the Natural History Stud through age 10 years, to determine whether the reduction in the benefit of cryotherapy seen between ages 12 and 42 months continues into mid-childhood. Evaluation of the effects of cryotherapy will be based on examination findings in the posterior pole of the eye and on assessment of visual acuity, as in Phase II. In addition, a more complete evaluation of visual acuity will be conducted at age 9 years, through assessment of monocular contrast sensitivity, monocular contrast sensitivity, monocular color vision, and stereopsis, and at age 10 years, through measurement of the extent of the visual field by Goldmann perimetry.

描述（研究者的摘要） 拟议研究的目的是检验长期结构性 冷冻疗法治疗严重疾病的功能效果 早产儿视网膜病变（ROP）。 在研究的初始阶段， 具有 5 个连续或 8 个总时钟小时的第 3 阶段加 ROP 的眼睛， 291 名出生体重低于 1251 克的婴儿被随机分组 是否接受冷冻治疗 冷冻疗法。 12 个月大时的随访表明冷冻疗法 不良结构结果的发生率降低了 45.8% 视力不良的发生率降低了 37.8%。 根据初步数据，阶段随访至 42 个月 研究 II 表明冷冻疗法降低了以下疾病的发生率： 不利的结构性结果达 39.1%。 至于愿景， 冷冻疗法降低了不良分辨率的发生率 结果提高了 21.4%，根据测量结果提高了 19.7% 的识别敏锐度。 本研究建议对随机分组的患者进行随访， 一个相对较小的潜在高风险患者亚组（67） 自然历史研究直到 10 岁，以确定是否 12 岁至 42 岁之间冷冻疗法的效果有所下降 几个月一直持续到童年中期。 效果评估 冷冻治疗将基于后极检查结果 与第二阶段一样，对眼睛进行检查并评估视力。 在 此外，还将对视力进行更完整的评估 9岁时，通过单眼对比敏感度评估， 单眼对比敏感度、单眼色觉和立体视觉， 10岁时，通过测量视觉范围 戈德曼视野计的视野。