EARLY TMT RETINOPATHY OF PREMATURITY HEADQUARTER GRANT

早期 TMT 早产儿视网膜病变总部拨款

• 批准号: 7277196
• 负责人: WILLIAM V GOOD
• 金额: $ 20.51万
• 依托单位: SMITH-KETTLEWELL EYE RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-30 至 2009-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7277196
• 关键词: Ablation; Blindness; Child; Clinical Trials; Disease; Early treatment; Enrollment; Eye; Grant; Infant; National Eye Institute; Numbers; Outcome; Peripheral; Premature Infant Diseases; Probability; Randomized; Rate; Retinal; Retinal Detachment; Retinopathy of Prematurity; Risk; Risk Factors; Risk Management; Staging; Time; Treatment outcome; Vision; Visual; improved; programs; retina blood vessel structure

Retinopathy of prematurity (ROP) is a potentially blinding disease of premature infants in which retinal blood vessels fail to develop properly. A multicentered clinical trial (CRYO-ROP Study) sponsored by the National Eye Institute demonstrated that peripheral retinal ablation at a defined stage of the disease reduced the risk of unfavorable structural outcome (i.e., retinal detachment); however, over 47.1 percent of treated eyes had vision greater than 20/200 at 5 1/2 years. The CRYO-ROP Study also defined a number of risk factors for unfavorable visual and structural outcome in ROP. Despite these advances, ROP remains a leading cause of blindness in children. More effective treatment is required in order to further reduce the rate of blindness. It is hypothesized that earlier treatment of ROP will improve the visual and structural outcome in infants with ROP. Peripheral retinal ablation will be administered to infants who develop prethreshold ROP (ROP that is severe, but not as advanced as threshold ROP as defined by the CRYO-ROP Study). To minimize the risk of treating eyes unnecessarily, since ROP may regress spontaneously in some cases, we will apply a risk management analysis program (RM-ROP2) to eyes with prethreshold disease and enroll infants with a 15 percent or greater risk of an unfavorable structural outcome for treatment. The RM-ROP2 utilizes a number of risk factors to calculate the probability of an eye having an unfavorable structural outcome. Prethreshold infants with a 15 percent or higher risk of an unfavorable outcome will be randomized. One eye will receive earlier treatment and the other will receive conventionally-timed treatment, as defined by the CRYO-ROP Study if required. Outcome will be determined at a 6 month post-term ophthalmologic examination and at a 9 month post-term visual assessment examination.

预性预性（ROP）是一种早产婴儿的盲目疾病，其中视网膜血管无法正常发育。 由国家眼科研究所发起的一项多中心临床试验（冷冻研究）表明，在疾病的定义阶段，周围视网膜消融降低了不利的结构性结果的风险（即视网膜脱离）。但是，超过47.1％的眼睛在5 1/2年的视力大于20/200。 该冷冻研究还定义了ROP中不利的视觉和结构结果的许多风险因素。 尽管取得了这些进步，但ROP仍然是儿童失明的主要原因。 为了进一步降低失明率，需要更有效的治疗方法。假设较早的ROP治疗将改善ROP婴儿的视觉和结构性结果。 外围视网膜消融将对发展为Prethreshold ROP的婴儿（严重的ROP，但不如Cryo-Rop研究所定义的阈值ROP高级ROP）。 为了最大程度地减少不必要地治疗眼睛的风险，因为在某些情况下，ROP可能会自发地退化，我们将应用风险管理分析计划（RM-ROP2）对患有prethreshold疾病的眼睛，并招募患有不利结构性结构结果风险的婴儿。 RM-ROP2利用许多风险因素来计算眼睛具有不利结构结果的概率。 将随机分配为不利结果风险15％或更高风险的prethreshold婴儿。 一只眼睛将接受较早的治疗方法，另一种眼睛将接受常规时定的治疗，如需要的（如果需要）的情况下，则定义。 结局将在后期眼科检查后6个月和后期的视觉评估检查中确定。