Final results of the Early Treatment for Retinopathy of Prematurity (ETROP) randomized trial.
Final results of the Early Treatment for Retinopathy of Prematurity (ETROP) randomized trial.
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发表时间：
2004
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通讯作者：
W. Good
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作者：
W. Good
目的介绍早产儿视网膜病变早期治疗研究的最终结果。方法：317例双侧高危阈值前早产儿视网膜病变（ROP）患儿，随机选择一只眼进行早期视网膜消融治疗，另一只眼进行常规治疗（对照眼）。在不对称病例（n = 84）中，将阈值前ROP高危眼随机分为早期治疗组和常规治疗组。使用基于早产儿视网膜病变自然史队列的冷冻治疗模型确定高风险。主要结果是由戴面具的测试者使用Teller视力卡程序评估视力。在6个月和9个月时进行结构检查。结果光栅视力结果显示，早期治疗的不良视力结果从19.8%降低到14.3%（P <0.005）。9个月时，不良结构结局从15.6%降至9.0%（P <0.001）。进一步的分析支持视网膜消融治疗I型ROP的眼睛，定义为I区，任何阶段的ROP+疾病; I区，3期ROP无+疾病;或II区，2期或3期+疾病。该分析支持对II型ROP的“等待和观察”方法，II型ROP定义为I区，1期和2期无正疾病，或II区，3期无正疾病。只有当这些眼睛进展到I型ROP或阈值时，才应考虑治疗。结论：早期治疗高危阈值前ROP可显著降低主要和次要（结构性）指标的不良结局。
PURPOSE To present the final results of the Early Treatment for Retinopathy of Prematurity Study. METHODS Infants with bilateral high-risk prethreshold retinopathy of prematurity (ROP) (n = 317) had one eye randomized to early retinal ablative treatment and the fellow eye managed conventionally (control eye). In asymmetric cases (n = 84), the eye with high-risk prethreshold ROP was randomized to early or to conventional management. High risk was determined using a model based on the Cryotherapy for Retinopathy of Prematurity natural history cohort. The primary outcome was visual acuity assessed by masked testers using the Teller acuity card procedure. Structural examinations were performed at 6 and 9 months. RESULTS Grating acuity results showed a reduction in unfavorable visual acuity outcomes with earlier treatment, from 19.8% to 14.3% (P < .005). Unfavorable structural outcomes were reduced from 15.6% to 9.0% (P < .001) at 9 months. Further analysis supported retinal ablative therapy for eyes with type I ROP, defined as zone I, any stage ROP with plus disease; zone I, stage 3 ROP without plus disease; or zone II, stage 2 or 3 with plus disease. The analysis supported a "wait and watch" approach to type II ROP, defined as zone I, stage 1 and 2 without plus disease, or zone II, stage 3 without plus disease. These eyes should be considered for treatment only if they progress to type I ROP or threshold. CONCLUSION Early treatment of high-risk prethreshold ROP significantly reduced unfavorable outcomes in both primary and secondary (structural) measures.