EARLY TMT RETINOPATHY OF PREMATURITY HEADQUARTER GRANT

早产儿早期 TMT 视网膜病变总部拨款

• 批准号: 6179064
• 负责人: WILLIAM V GOOD
• 金额: $ 11.08万
• 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 2004-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6179064
• 关键词: blindness; clinical research; clinical trials; cooperative study; disease /disorder prevention /control; eye surgery; human subject; human therapy evaluation; infant human (0-1 year); retinopathy of prematurity

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.

早产儿视网膜病变（ROP）是早产儿的一种潜在致盲性疾病，其中视网膜血管不能正常发育。 由国家眼科研究所赞助的一项多中心临床试验（CRYO-ROP研究）表明，在疾病的限定阶段进行外周视网膜消融可降低不利结构结局的风险（即，视网膜脱离）;然而，超过47.1%的治疗眼在5年半时视力大于20/200。 CRYO-ROP研究还定义了ROP中不利视觉和结构结局的许多风险因素。 尽管有这些进步，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。据推测，ROP的早期治疗将改善ROP婴儿的视觉和结构结果。 将对发生阈值前ROP（严重ROP，但不像CRYO-ROP研究定义的阈值ROP那么严重）的婴儿进行周边视网膜消融。 为了最大限度地减少不必要治疗眼睛的风险，由于ROP在某些情况下可能会自发消退，我们将对阈值前疾病的眼睛应用风险管理分析程序（RM-ROP 2），并招募具有15%或更高风险的婴儿进行治疗。 RM-ROP 2利用许多风险因素来计算眼睛具有不利结构结果的概率。 阈值前婴儿的不利结局风险为15%或更高，将被随机分组。 一只眼睛将接受早期治疗，另一只眼睛将接受常规时间的治疗，如需要，根据CRYO-ROP研究的定义。 将在6个月后的眼科检查和9个月后的视力评估检查时确定结局。