CRYO-ROP VISUAL ACUITY CENTER

说明(调查人员摘要) 建议研究的目的是研究香港的长远结构 冷冻治疗对重症急性胰腺炎的功能影响 早产儿视网膜病变(ROP)。在研究的初始阶段， 眼睛连续5个或8个总时钟小时的阶段3加上ROP，291 出生体重小于1251克的婴儿被随机接受 不管是不是冷冻治疗。对12个月的随访表明 冷冻治疗通过以下方式减少不良结构结局的发生率 45.8%和不良视力结局的发生率 37.8%。根据初步数据，随访至42个月 在第二阶段的研究中表明，冷冻治疗降低了 不良结构结果发生率下降39.1%。至于 视力、冷冻治疗降低了不良分辨率的发生率 敏感度结果提高21.4%，基于 识别敏锐度的测量。 本研究建议对随机组中的患者进行跟踪调查，并 潜在高危患者的相对较小的亚组(67人) 通过10年的自然历史研究，来确定 12岁至42岁之间的冷冻治疗益处减少 几个月的时间一直持续到童年中期。项目效果的评估 冷冻治疗将基于后极的检查结果。 和视力评估，如在第二阶段。 此外，还将对视觉功能进行更全面的评估 在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， 在10岁时，通过测量视力范围 戈德曼视野测量仪的视野。

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 g., were randomized to receive cryotherapy or no 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 study 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 function 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.