EARLY TMT/RETINOPATHY OF PREMATURITY (ETROP)- COORD CTR

早产儿视网膜病变(ROP)是早产儿视网膜血管发育不良的一种潜在致盲疾病。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，在疾病的特定阶段进行周边视网膜切除术可以降低不良结构结果(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年半时视力大于或等于20/200。CRYO-ROP研究还确定了ROP患者不良视觉和结构结局的一些危险因素。尽管取得了这些进展，ROP仍然是导致儿童失明的主要原因。为了进一步降低失盲率，需要进行更有效的治疗。据推测，早期治疗ROP将改善ROP婴儿的视觉和结构结果。周边视网膜消融术将用于出现阈值前ROP(ROP严重，但不像冷冻ROP研究定义的阈值ROP那么严重)的婴儿。为了最大限度地减少不必要地治疗眼睛的风险，由于ROP在某些情况下可能会自发退化，我们将对患有阈值前疾病的眼睛应用风险管理分析程序(RM-ROP2)，并招募结构不良结果风险为15%或更高的婴儿进行治疗。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。具有15%或更高不良结局风险的临界值前婴儿将被随机分组。如果需要，一只眼睛将接受更早的治疗，另一只眼睛将接受按照低温ROP研究定义的常规时间治疗。结果将在学期后6个月的眼科检查和9个月的学期后视力评估检查中确定。

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 or equal to 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.