EARLY TMT RETINOPATHY OF PREMATURITY HEADQUARTER GRANT

早产儿视网膜病变（ROP）是早产儿视网膜血管不能正常发育的一种潜在致盲疾病。由美国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，在疾病的特定阶段，周围视网膜消融可降低不良结构结果（即视网膜脱离）的风险；然而，超过47.1%的接受治疗的眼睛在5年半时视力超过20/200。CRYO-ROP研究还定义了ROP中一些不利的视觉和结构结果的危险因素。尽管取得了这些进展，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，早期治疗ROP将改善ROP婴儿的视觉和结构结果。外周视网膜消融将用于发生阈前ROP（严重的ROP，但不像CRYO-ROP研究定义的阈前ROP那么严重）的婴儿。由于ROP在某些情况下可能会自发消退，为了将不必要的眼睛治疗风险降至最低，我们将对具有阈前疾病的眼睛应用风险管理分析程序（RM-ROP2），并招募具有15%或更大不利结构结果风险的婴儿进行治疗。RM-ROP2利用许多风险因素来计算眼睛出现不利结构结果的概率。有15%或更高不良结局风险的阈前婴儿将被随机分组。如果需要，一只眼睛将接受早期治疗，另一只眼睛将接受CRYO-ROP研究定义的常规定时治疗。术后6个月的眼科检查和术后9个月的视力评估检查将决定结果。

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.