课题基金 / 基金详情

CRYO-ROP VISUAL ACUITY CENTER

CRYO-ROP VISUAL ACUITY CENTER
CRYO-ROP 视力中心
批准号:
2159627
负责人:
EARL A PALMER
金额:
$18.1万
依托单位国家:
美国
项目类别:
财政年份:
1990
资助国家:
美国
项目状态:
已结题
起止时间:
1990-06-01 至 1999-05-31

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项目成果

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中文摘要
翻译
描述(研究者摘要) 建议研究的目的,是研究香港的长远结构, 冷冻疗法作为治疗严重 早产儿视网膜病变(ROP)。 1986年1月,体重较轻的婴儿 1251 g。 在出生时,首先参加了一项前瞻性检查, 这一序列导致291名这样的婴儿参与了一项 冷冻治疗的一项随机试验, ROP。 对12个月大的婴儿的随访表明,冷冻治疗减少了 不良结构性结局的发生率降低了45.8%, 视力不良发生率下降37.8%。 基于 根据初步数据,在第二阶段随访至12个月大, 该研究表明,冷冻治疗降低了不良反应的发生率, 结构性成果39.1%。 至于视力,冷冻治疗降低了 不良缓解视力结局的发生率降低了21.4%, 而根据识别敏锐度的测量,则为19.7%。 的 治疗眼和未治疗眼之间的结果差异减小 眼睛,特别是视力,引起足够的不确定性, 继续跟踪这一种群直到撞击发生 冷冻治疗对这些患者的眼睛视觉发育的影响, 童年是可以建立的。 有必要将这一新兴的治疗方法应用于临床 perspective.登记的儿童代表了一个独特的群体, 对照组的眼睛可用于比较。 现时的建议 将继续跟踪随机化患者, 额外的亚组(67例)潜在高风险患者(近 有资格进行治疗试验)至10岁,以确定 数据显示的冷冻治疗的益处减少 在12至12个月之间,将持续到儿童中期。 冷冻治疗的结果和效果的评价将基于 眼睛后极的检查结果和评估 视觉。 除了敏锐度,视力将在9岁时进行评估 在单眼对比敏感度、单眼色觉和 立体视觉;在10岁时,通过测量 Goldmann视野计视野。
英文摘要
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 January 1986, infants weighing less than 1251 g. at birth were first enrolled in a prospective examinations sequence that led to the participation of 291 such infants in a randomized trial of cryotherapy for a specified threshold severity of ROP. 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 12 months during Phase II of the study indicates 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 diminished outcome difference between the treated eyes and the untreated eyes, particularly for visual acuity, raises sufficient uncertainty that it is deemed vital to continue following this population until the impact of cryotherapy on ocular visual development in these patients through childhood can be firmly established. It is necessary to place this newly popular therapy into clinical perspective. The enrolled children represent a unique group in which a control group of eyes is available for comparison. The present proposal would continue to follow the randomized patients and a relatively small additional subgroup (67) of potentially high risk patients (who nearly qualified for the therapy trial) through age 10 years, to determine whether the reduction in the benefit of cryotherapy suggested by the data between ages 12 and 12 months will continue into mid-childhood. Evaluation of outcome and the effects of cryotherapy will be based on examination findings in the posterior pole of the eye and on assessment of vision. In addition to acuity, vision will be assessed at age 9 years in terms of 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.
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